federal guidance on emergeny drug kits containing ... kit compliance overview provided to dopl on...
TRANSCRIPT
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Emergency Kit Compliance Overview Provided to DOPL on 2122014 by Jared Memmott
Federal Guidance on Emergeny Drug Kits Containing Controlled Substances
httpllwwvvdeadiversionusdojgovfaqgeneralhtm (Frequently Asked Questions from DEA Diversion website)
httpllwwwdeadiversionusdoLgovfed regsnoticesotherfr 0409l980pdf (Original publication of in the Federal Register Vol 45 No 70 Wednesday April 9 1980)
Question Can aft LTCF store cofttrolled substaftces ift aft emergency kit without being registered with DEA
Answer DEA published the following Statement of Policy in the April 9 1980 Federal Register regarding the placement of controlled substances in an emergency kit located in an LTCF
STATEMENT OF POLICY
The placement of emergency kits containing controlled substances in non-federally registered Long Term Care Facilities (LTCF) shall be deemed to be in compliance with the Comprehensive Drug Abuse Prevention and Control Act of 1970 if the appropriate state agency or regulatory authority specifically approves such placement and promulgates procedures which delineate
A The source from which an LTCF may obtain controlled substances for emergency kits The source of supply must be a DEA registered hospitaUclinic pharmacy or practitioner
B Security safeguards for each emergency kit stored in the LTCF which include the designation of Individuals who may have access to the emergency kits and a specific Iimitation of the type and quantity of controlled substances permitted to be placed in each emergency kit
C Responsibility for proper control and accountability of such emergency kits within the LTCF to include the requirement that the LTCF and the providing DEA registered hospitalclinic pharmacy or practitioner maintain complete and accurate records of the controlled substances placed in the emergency kit the disposition of these controlled substances plus the requirement to take periodic physical inventories
D The emergency medical conditions under which the controlled substances may be administered to patients in the LTCF to include the requirement that medication be administered by authorized personnel only as expressly authorized by an individual practitioner and in compliance with the provisions of21 CFR 130611 and 21 CFR 130621
E Prohibited activities which can result in the state revocation denial or suspension of the privilege of having or placing emergency kits containing controlled substances in an LTCF
IMPORTANT POINTS
~ 21 CFR 130611 pertains to the requirements of a CII prescription and only being able to dispense a prescription pursuant to a prescription
~ 21 CFR 130621 pertains to the requirements of a CIII-V prescription and only being able to dispense a prescription pursuant to a prescription
Page 1 of 5
Emergency Kit Compliance Overview Provided to DOPL on 2122014 by Jared Memmott
Emergency Kit Guidance from the American Society of Consultant Pharmacists
Question When is a nurse authorized to remove a controlled drug from an e-kit
Answer Controlled drugs in e-boxes are treated the some way as all other conrrolled drugs Before a drug can be removed there must be a volid written prescription Iwhich may be a fax unless the emergency exception applies E-boxes should never be used routinely to dispense drugs that should hove been reordered Raiher e-boxes should be used only for unanticipated emergendes that may be a new admission or a new order Due to the importance of state law in authorizing the use of eshykits in long-term care it is critical that practitioners pharmacists and facilities understond all pertishynent stole lows and regulotions governing e-kits in oddition to federal requirements
Question What are the potential consequences if nurse take a controlled drug from e-kit before the practitioner has issued a valid prescription
Answer Taking possession of a controlled drug without proper authorization con be a serious offense A nurse who removes a controlled drug from on e-kit without volid authorization may be subject to civil and criminal fines and penalties disciplinary action by the state licensing board and exclusion from federal health core programs
Question Is it permissible for a nurse to remove a controlled drug from an e-kit if slhe has received an oral order from the practitioner
Answer Some states permit this practice However DEA rules require that the practitioner provide oral authorization or a foxed prescription to the pharmacist before a drug is dispensed Consequently a practitioner who gives an oral order to the nurse in the facility by telephone must
also ensure that the pharmacy receives either an oral emergency order or a written prescription order (which may be sent via facsimile)
Question Can a nurse in a long-term care facility remove drugs from an E-kit based upon a standing order
Answer No An e-kit should only used in an emergency situation which by definition must be unanticipated
Question Can a nurse remove a CII from an e-kit for a patient who already has a valid prescription for a ell drug but has run out of medication at 200 am
Assuming this situation meets the criteria for an emergency situation the nurse would need to contact the practitioner for an orol authorization (which must be communicated by the pradifQner to the pharmacist either orally or by fax) While these situations sometimes cannot be avoided nursing facilities and pharmacies should hove systems in pJoce that ensure the timely reshyordering of medications for patients with on-going need for pain management
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Page 2 of 5
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Emergency Kit Compliance Overview Provided to DOPL on 2122014 by Jared Memmott
Conflicts with Current Utah Statute
The Utah Controlled Substance Act in UCA sect 58-37-6 (2)(e) states
A separate license is reg uired at each principal place of business or professional practice where the applicant manufactures produces distributes dispenses conducts research with or performs laboratory analysis upon controlled substances
The Utah Pharmacy Practice Act in U CA sect 58-17b-302(3) states
Each place of business shall require a separate license If multiple pharmacies exist at the same address a separate license shall be required for each pharmacy
Conflicts with Current Utah Administrative Rules
R432 Health Family Health and Preparedness Licensing
Rule R432-1 50 Nursing Care Facility
R432-150-19 Pharmacy Services
(1) The facility must provide or obtain by contract routine and emergency drugs biologicals and pharmaceutical
services to meet resident needs
(2) The facility must employ or obtain the services of a licensed pharmacist who
(a) provides consultation on all aspects of pharmacy services in the facility
(b) establishes a system of records of receipt and disposition of all controlled substances which documents an
accurate reconciliation and
(c) determines that drug records are in order and that an account of all controlled substances is maintained and
reconciled monthly_
(3) The drug regimen of each resident must be reviewed at least once a month by a licensed pharmacist
(a) The pharmacist must report any irregularities to the attending physician and the director of nursing or health
services supervisor
(b) The physician and the director of Nursing or health services supervisor must indicate acceptance or rejection of
the report and document any action taken
(4) Pharmacy personnel must ensure that labels on drugs and biologicals are in accordance with currently accepted professional principles and include the appropriate accessory and cautionary instructions and the expiration date
(5) The facility must store all drugs and biologicals in locked compartments under proper temperature controls according to R432- I 50- I 9 (6)e) and permit only authorized personnel to have access to the keys
Page 3 of 5
Emergency Kit Compliance Overview Provided to DOPL on 2122014 by Jared Memmott
(a) The facility must provide separately locked permanently affixed compartments for storage of controlled substances listed in Schedule II of the Comprehensive Drug Abuse Prevention and Control Act of 1976 and other drugs subject to abuse except when the facility uses single unit dose package drug distribution systems in which the
quantity stored is minimal and a missing dose can be readily detected
(b) Non-medication materials that are poisonous or caustic may not be stored with medications
(c) Containers must be clearly labeled
(d) Medication intended for internal use shall be stored separately from medication intended for external use
(e) Medications stored at room temperature shall be maintained within 59 and 80 degrees F
() Refrigerated medications shall be maintained within 36 and 46 degrees F
(6) The facility must maintain an emergency drug supply
(a) Emergency drug containers shall be sealed to prevent unauthorized use
(b) Contents of the emergency drug supply must be listed on the outside of the container and the use of contents shall be documented by the nursing staff
(c) The emergency drug supply shall be stored and located for access by the nursing staff
(d) The pharmacist must inventory the emergency drug supply monthly
(e) Used or outdated items shall be replaced within 72 hours by the pharmacist
(7) The pharmacy must dispense and the facility must ensure that necessary drugs and biologicals are
provided on a timely basis
(8) The facility must limit the duration of a drug order in the absence of tbe prescribers specific
instructions
(9) Drug references must be available for all drugs used in the facility References shall include generic and brand
names available strength and dosage forms indications and side effects and other pharmacological data
(10) Drugs may be sent with the resident upon discharge if so ordered by the discharging physician provided
tbat
(a) such drugs are released in compliance R156-17a-619 and
(b) a record of the drugs sent with the resident is documented in the residents health record
(II) Disposal of controlled substances must be in accordance with the Pharmacy Practice Act
Page 4 of 5
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Emergency Kit Compliance Overview Provided to DOPL on 2122014 by Jared Memmott
IMPORTANT POINTS
~ The practice of pharmacy definition and the above described statute prohibit anyone other than a properly licensed pharmacy from possessing stock controlled substances or legend drugs
~The Utah Department of Health has invalid and antiquated administrative rules that supersedes what statute does not allow and existing pharmacy law and rule does not even address some of the operating standards mandated by the pharmacist and pharmacy who are providing pharmacy services
~As the Federal Register states that emergency kits in Long Term Care Facilities are only viewed as compliant with the Controlled Substance Act IF the appropriate state agency or regulatory authority specifically approves such placement anltLQ()lgates procedures which delineate The Utah Department of Health is not the appropriate state agency and moreover the appropriate Utah statute conflicts with the inappropriate state agency administrative rules
~ Additionally the existing administrative rules do not define and cover everything mandated in the Federal Register to even be considered compliant
Page 5 of 6
State of Utah Department of Comnlerce Division of Occupational and Professional Licensing
GARY R HERBERT FRANCINEA GIANI MARK B STEINAGEL GOlernnr Executive Director DiviSIOn Director
GUIDELINES FOR HOSPITAL PHARMACIES and EMERGENCY DEPARTMENT TREATMENT
Approved by the Board of Pharmacy May 21 2012
The pharmacist is responsible for all pharmacy practice as del ineated under Utah Code 58-17b and 58-37fto include
bull ordering receiving and stocking bull filling drug carts drug rooms emergency drug stocks bull controlling inventory including audit trail [or each controlled substance bull maintaining and adhering to policies and protocols that maintain controls over controlled
substances (Utah Controlled Substances Act Subsection R156-37-502 defines unprofessional conduct to include (4) failing to maintain controls over controlled substances which would be considered by a prudent practitioner to be effective against diversion theft or shortage of controlled substances (5) being unable to account for shortages of controlled substances for any controlled substance inventory for which the licensee has responsibility)
bull reviewing Medication Proof of Use forms or logs returned to the pharmacist for purposes of review and reconciliation and
bull submitting all required controlled substance prescription information to the Controlled Substance Database pursuant to Utah Code 58-37f-203
NOTE Responsible means accountable for The pharmacist may delegate the task yet is ultimately accountable for the outcome Final checks of medications or medication profiles cannot be delegated
After-hours Medications Taken from Pharmacy When a Pharmacy is Closed
Only a pharmacist nurse supervisor or charge nurse can enter the pharmacy when the bull pharmacy is closed Medications can only be taken from the pharmacy on an emergency as needed basis Abull medication log must be used to keep a per medication inventory Only a pharmacist nurse supervisor or charge nurse can have access and the alarm code bull to whel1_~ltj)armacL~19~~~alth0lglil~one~~tthe p(irmacist can _~~___ ~ have a key to the locked controlled substance inventory in the pharmacy The pharmacy must still be equipped with a security system to permit detection of entry at all times when the facility is closed An adequate security system for inpatient phannacies within hospitals would be a system similar to a badge reader access which could uniquely store and retain which authorized person had made entry into the pharmacy after regular hours
wwwdoplulahgoYmiddot Heber M Wells Buildingmiddot 160 East300 South PO Box 146741 Salt Lake City UT 84114-6741 telephone (801) 530-6628 bull tollmiddot free in Utah (866) 275-3675 bull fax (801) 530-651 1 bull investigations fax (801) 530middot630 I UTAH
Dispensing of Drugs from an Emergency Room
bull Emergency room staff including the prescribing practitioner or Iicensed nurse cannot dispense prescriptions to a patient The prescribing practitioner can give an emergency supply which is properly labeled to a patient to get a patient started on the medication until a pharmacy is open This is not to be construed to allow a prescribing practitioner to give out an entire prescription amount
The related community standard for the treatment of typical Emergency Department conditions and STI prophylaxis is seven days
bull Such emergency doses of medications shall be labelcd with at least -Prescribing practitioners name and facility name and telephone number -Patients name -Name ormedication and strength -Number oftablets given -Date given and -I nstrLlctions for use
bull Records of controlled substances dispensed by the prescribing practitioner must be provided to the pharmacy so that applicable prescription data can be reported to the CSD
NOTE Physicians may give out samples which are clearly marked as a sample not for resale unti I the patient can get to a pharmacy or to try the medication for possible untoward effects Samples must be dispensed pursuant to Utah Code Annotated sect 58shy17b-610
Repackaging bull It is illegal for retail phannacies to repackage medications for resale to hospitals clinics
or other pharmacies The hospital pharmacy could legally repackage medications for use in its own institution
Federal Statute
According to Federal regulations repackaging requires a manufacturers license as stated in US Code 21-130001(27) and USC 21-1301lI(a)
USC 21-130001 reads Manufacture means the producing preparation propagation compounding or processing of a drug or other substance or the packaging or repackaging of such substance or the labeling or relabeling of the commercial container of such substance but
~----- middotmiddotmiddotmiddot_~aoesmmiddotnot IncluOelne-aCliiities omiddotf-a-praclilioifef-wlio~middotasan1nci(rentwhlS1hmiddoteraoffilnistratle)ffT5f-
dispensing such substance in the course of hisher professional practice prepares compounds packages or labels such substance
USC 21-130111 (a) reads Every person who manufactures distributes dispenses imports or exports any controlled substances or who proposes to engage in the manufacture distribution dispensing importation or exportation of any controlled substances shall obtain a registration
wwwdoptutahgovmiddot Heber M Wells Buildingmiddot 160 East 300 Southmiddot PO Box 146741 Salt Lake City UT 84114-6741 telephone (801) 530-6628middot toll-free in Utah (866) 275-3675 fax (801) 530-6511 investigations fax (801) 530-6301
LEGISLA TIVE GENERAL COUNSEL SB178 ct Approved for Filing Sc Allred ct
ct 02-05-14 1 56 PM ct
1 CONTROLLED SUBSTANCE DATABASE MODIFICATIONS
2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Evan J Vickers
5 House Sponsor Bradley G Last
6
7 LONG TITLE
8 General Description
9 This bill modifies the Controlled Substance Database Act regarding access by pharmacy
10 technicians
11 Highlighted Provisions
12 This bill
13 ~ allows the phannacist-in-charge to designate a licensed phannacy technician to have
14 access to the database on behalf of the phannacist in accordance with statutory
15 requirements
16 Money Appropriated in this Bill
17 None
18 Other Special Clauses
19 None
20 Utah Code Sections Affected
21 AMENDS
22 58-37fmiddot301 as last amended by Laws of Utah 2013 Chapters 12 130 and 262
23
24 Be it enacted by the Legislature ofthe state ofUtah
25
26
27
Section 1 Section 58-37fmiddot301 is amended to read
58-37fmiddot301 Access to database
(1) The division shall make rules in accordance with Title 63G Chapter 3 Utah
rJlbull =bull
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02-05-14 156 PM SB178
59 (A) fit within the responsibilities of the Department of Health for health and welfare
60 (B) are reviewed and approved by an Institutional Review Board that is approved for
61 human subject research by the United States Department of Health and Human Services and
62 (C) are not conducted for profit or commercial gain and
63 (D) are conducted in a research facility as defined by division rule that is associated
64 with a university or college in the state accredited by the Northwest Commission on Colleges
65 and Universities
66 (iii) the designee protects the information as a business associate of the Department of
67 Health and
68 (iv) the identity of the prescribers patients and pharmacies in the database are
69 de-identified confidential not disclosed in any manner to the designee or to any individual
70 who is not directly involved in the scientific studies
71 (e) a licensed practitioner having authority to prescribe controlled substances to the
72 extent the information
73 (i) (A) relates specifically to a current or prospective patient of the practitioner and
74 (B) is provided to or sought by the practitioner for the purpose of
75 (I) prescribing or considering prescribing any controlled substance to the current or
76 prospective patient
77 (II) diagnosing the current or prospective patient
78 (nn providing medical treatment or medical advice to the current or prospective
79 patient or
80 (IV) determining whether the current or prospective patient
81 (Aa) is attempting to fraudulently obtain a controlled substance from the practitioner
82 or
83 (Bb) has fraudulently obtained or attempted to fraudulently obtain a controlled
84 substance from the practitioner
85 (ii) (A) relates specifically to a fonner patient of the practitioner and
86 (B) is provided to or sought by the practitioner for the purpose of determining whether
87 the former patient has fraudulently obtained or has attempted to fraudulently obtain a
88 controlled substance from the practitioner
89 (iii) relates specifically to an individual who has access to the practitioners Drug
- 3 shy
02-05-14 156 PM SB178
121 58-3 7f-203(3 )(b) with respect to the employee
122 (h) a licensed pharmacist having authority to dispense a controlled substance to the
123 extent the information is provided or sought for the purpose of
124 (i) dispensing or considering dispensing any controlled substance or
125 (ii) determining whether a person
126 (A) is attempting to fraudulently obtain a controlled substance from the pharmacist or
127 (B) has fraudulently obtained or attempted to fraudulently obtain a controlled
128 substance from the pharmacist
129 (i) in accordance with Subsection (3)(a) a licensed pharmacy technician who is an
]30 employee of a pharmacy as defined in Section 58-17b-l 02 for the purposes described in
131 Subsection (2)(h)(i) or (iO if
132 0) the employee is designated by the pharmacist-in-charge as an individual authorized
133 to access the information on behalf of a licensed pharmacist employed by the pharmacy
134 (ii) the pharmacist-in-charge provides written notice to the division of the identity of
135 the employee and
136 (iii) the division
137 CA) grants the employee access to the database and
138 (B) provides the employee with a password that is unique to that employee to access
139 the database in order to permit the division to comply with the requirements of Subsection
140 58-37f-203(3)(b) with respect to the employee
141 [fiJ] ill federal state and local law enforcement authorities and state and local
142 prosecutors engaged as a specified duty of their employment in enforcing laws
143 (i) regulating controlled substances
144 (ii) investigating insurance fraud Medicaid fraud or Medicare fraud or
145 (iii) providing information about a criminal defendant to defense counsel upon request
146 during the discovery process for the purpose of establishing a defense in a criminal case
147 [61] fhl employees ofthe Office oflntemal Audit and Program Integrity within the
148 Department of Health who are engaged in their specified duty of ensuring Medicaid program
149 integrity under Section 26-18-23
150 [fki] ill a mental health therapist if
151 (i) the information relates to a patient who is
- 5 shy
02-05-14 156 PM SB178
183 designated under Subsection (2)(f) (2)(g) or (4)(c) should be granted access to the database
184 and
185 (ii) establish the information to be provided by an emergency room employee under
186 Subsection (4)
187 (c) The division shall grant an employee designated under Subsection (2)(f) (2)(g) or
188 (4)( c) access to the database unless the division determines based on a background check that
189 the employee poses a security risk to the information contained in the database
190 (4) (a) An individual who is employed in the emergency room ofa hospital may
191 exercise access to the database under this Subsection (4) on behalf of a licensed practitioner if
192 the individual is designated under Subsection (4)( c) and the licensed practitioner
193 (i) is employed in the emergency room
194 Oi) is treating an emergency room patient for an emergency medical condition and
195 (iii) requests that an individual employed in the emergency room and designated under
196 Subsection (4)( c) obtain information regarding the patient from the database as needed in the
197 course of treatment
198 (b) The emergency room employee obtaining information from the database shall
199 when gaining access to the database provide to the database the name and any additional
200 identifiers regarding the requesting practitioner as required by division administrative rule
201 established under Subsection (3)(b)
202 (c) An individual employed in the emergency room under this Subsection (4) may
203 obtain information from the database as provided in Subsection (4)(a) if
204 (i) the employee is designated by the practitioner as an individual authorized to access
205 the information on behalf of the practitioner
206 (ii) the practitioner and the hospital operating the emergency room provide written
207 notice to the division of the identity of the designated employee and
208 (iii) the division
209 (A) grants the employee access to the database and
210 (B) provides the employee with a password that is unique to that employee to access
211 the database in order to permit the division to comply with the requirements of Subsection
212 58-37f-203(3)(b) with respect to the employee
213 (d) The division may impose a fee in accordance with Section 63J-I-504 on a
- 7
LEGISLATIVE GENERAL C01JNSEL SB55 iL Approved for Filing Cl Dupont iL lst Sub (Green)
iL 02-07-14 416 PM iL
Senator Evan J Vickers proposes the following substitute bill
PHARMACEUTICAL DISPENSING AMENDMENTS
2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Evan J Vickers
5 House Sponsor Stewart Barlow
6
7 LONG TITLE
8 General Description
9 This bill amends the Pharmacy Practice Act to create a dispensing medical practitioner
10 license and a license classification for a dispensing medical practitioner clinic
11 pharmacy
12 Highlighted Provisions
13 This bill
14 defines terms
15 establishes the license classification dispensing medical practitioner under the
16 Pharmacy Practice Act for medical practitioners who prescribe and dispense a drug
17 establishes the pharmacy facility license classification dispensing medical
18 practitioner clinic pharmacy under the Pharmacy Practice Act
19 creates Part 8 Dispensing Medical Practitioner and Dispensing Medical Practitioner
20 Clinic Pharmacy
21 removes the exemption from the Pharmacy Practice Act for medical practitioners
22 who prescribe and dispense a cosmetic drug injectable weight loss drug or a cancer
23 drug treatment regimen
24 requires a license as a dispensing medical practitioner for a health care practitioner 00
25 to dispense bull bull=
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02-07-14 416 PM 1st Sub (Green) SB 55
615 Practitioner Clinic Pharmacy II
616 Section 8 Section 58-17b-802 is enacted to read
617 58-17b-802 Definitions
618 As used in this part
619 (1) (a) Cosmetic drug means a prescription drug that
620 (i) is for the purpose of promoting attractiveness or altering the appearance of an
621 individual and
622 (ii) (A) is listed as a cosmetic drug subject to the exemption under this section by the
623 division by administrative rule or
624 CB) has been expressly approved for online dispensing whether or not it is dispensed
625 online or through a physicians office
626 (b) Cosmetic drug does not include a prescription drug that is
627 (i) a controlled substance
628 (ii) compounded by the physician or
629 (iii) prescribed or used for the patient for the purpose of diagnosing curing or
630 preventing a disease
631 (2) Employer sponsored clinic means an entity that S-t has a medical director who is
631 a licensed as a physician as defined in Section 58-67-102 and S offers health care only to the
632 employees of an exclusive group of employers and the employees dependents
633 (3) Health care is as defined in Section 31A-1-301
634 (4) Ca) Injectable weight loss drug means an injectable prescription drug
635 (n prescribed to promote weight loss and
636 (ii) listed as an injectable prescription drug subject to exemption under this section by
637 the division by administrative rule
638 (b) Injectable weight loss drug does not include a prescription drug that is a
639 controlled substance
640 (5) Prepackaged drug means a prescription drug that
641 (a) is not listed under federal or state law as a Schedule I II ill IV or V drug and
642 (b) is packaged in a fixed quantity per package by
643 (i) the drug manufacturer
644 (ii) a pharmaceutical wholesaler or distributor or
645 (iii) a pharmacy licensed under this title
- 21 Senate Committee Amendments 2-13-2014 Jplcjd
1st Sub (Green) SB 55 02-07-14 416 PM
646 Section 9 Section 58-17b-803 is enacted to read
647 58-17b-803 Qualifications for licensure as a dispensing medical practitioner -shy
648 Scope of practice
649 (1) An applicant for a license as a dispensing medical practitioner shall
650 (a) be licensed in good standing under at least one of the chapters listed in Subsection
651 58-17b-l02(23)(a) and
652 (b) submit an application for a license as a dispensing medical practitioner in a form
653 prescribed by the division and pay a fee established by the S [depal tment] divisionS ~
654 (2) The division shall accept the licensing in good standing under Subsection (1) in lieu
655 of requiring an applicant for a license under this part to comply with Sections 58-17b-303 and
656
657 (3) A dispensing medical practitioner may dispense in accordance with this part
658 (a) a cosmetic drug and an injectable weight loss drug if
659 (i) the drug was prescribed by the dispensing medical practitioner to the dispensing
660 medical practitioners patient and
661 Oi) the dispensing medical practitioner complies with administrative rules adopted by
662 the division under Subsection 58-17-802(1)
663 (b) a cancer drug treatment regimen if the dispensing medical practitioner complies
664 with Section 58-17b-805 and
665 (c) a pre-packaged drug to an employee or a dependent of an employee at an employer
666 sponsored clinic if the dispensing medical practitioner
667 (i) treats an employee or the dependent of an employee of one of an exclusive group
668 of employers at an employer sponsored clinic
669 (ii) prescribes a prepackaged drug to the employee or the employees dependent
670 (iii) dispenses the prepackaged drug at the employer sponsored clinic and
671 (iv) complies with administrative rules adopted by the division in consultation with the
672 Board of Pharmacy that establish labeling record keeping patient counseling purchasing and
673 distribution operating treatment quality of care and storage requirements
674 (4) A dispensing medical practitioner
675 Ca) shall inform the patient
676 (i) that the drug dispensed by the practitioner may be obtained from a pharmacy
- 22 - Senate Committee Amendments 2-13-2014 picjd
02-07-14 416 PM 1st Sub (Green) SB 55
739 58-17b-806 Dispensing medical practitioner -- Dispensing medical practitioner
740 clinic pharmacy -- Unprofessional and Unlawful conduct
741 ill S Ull S The division S [ iii consultation witb tile boal d shall
742 (a) I epol t a violation of this chapter b a dispensing medical pi actitiollel to] shall consult
742a with S the
743 dispensing medical practitioners appropriate licensing board as designated in Subsection
744 5S-17b-l02(23)(a) S reeardine a violation oftMs chapterS and
745 (hl S the Pharmacy Board shall if requested by the licensine board of the dispensine
745a medical practitionerS assist the licensing board for the dispensing medical practitioner with
745b reviewing the
746 violations of the provisions of this chapter
747 (2) The division S [ in collabOi atioll with the Boal d ofPhall1l3C]S may take
747a appropriate
748 action against a dispensing medical practitioner in accordance with this chapter if the
749 licensing board designated in Subsection 58-17b- 02(23)(a) recommends to the division that
750 action be taken under this chapter
751 (3) The division in consultation with the board is the primary enforcer under this
752 chapter for a dispensing medical practitioner clinic pharmacy licensed under Section
753 58-17b-804
754 Section 13 Section 58-31b-502 is amended to read
755 58-31b-502 Unprofessional conduct
756 Unprofessional conduct includes
757 (l) failure to safeguard a patients right to privacy as to the patients person condition
758 diagnosis personal effects or any other matter about which the licensee is privileged to know
759 because of the licensees or person with a certifications position or practice as a nurse or
760 practice as a medication aide certified
761 (2) failure to provide nursing service or service as a medication aide certified in a
762 manner that demonstrates respect for the patients human dignity and unique personal character
763 and needs without regard to the patients race religion ethnic background socioeconomic
764 status age sex or the nature of the patients health problem
765 (3) engaging in sexual relations with a patient during any
766 (a) period when a generally recognized professional relationship exists between the
767 person licensed or certified under this chapter and patient or
768 (b) extended period when a patient has reasonable cause to believe a professional
769 relationship exists between the person licensed or certified under the provisions of this chapter
- 25 - Senate Committee Amendments 2-13-2014Iplcjd
LEGISLA TIVE GENERAL COUNSEL SB138 ct Approved for Filing Sc Allred ct
ct 02-04-14 1220 PM ct
1 CONTROLLED SUBSTANCES ACT AMENDMENTS
2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Evan J Vickers
5 House Sponsor Stewart Barlow
6
7 LONG TITLE
8 General Description
9 This bill modifies the Utah Controlled Substances Act regarding prescriptions for
10 controlled substances
11 Highlighted Provisions
12 This bill
13 ~ provides that more than one controlled substance may be included in a prescription
14 Money Appropriated in this Bill
15 None
16 Other Special Clauses
17 None
18 Utah Code Sections Affected
19 AMENDS
20 58-37-6 as last amended by Laws of Utah 2012 Chapter 272
21
22 Be it enacted by the Legislature of the state ofUtah
23 Section 1 Section 58-37-6 is amended to read
24 58-37-6 License to manufacture produce distribute dispense administer or
25 conduct research -- Issuance by division -- Denial suspension or revocation -- Records
26
27
required -- Prescriptions
(1) (a) The division may adopt rules relating to the licensing and control of the bull
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SB138 02-04-14 1220 PM
214 (ii) the prescribed controlled substance is to be used in research
215 (f) Except when administered directly to an ultimate user by a licensed practitioner
216 controlled substances are subject to the following restrictions
217 (i) (A) A prescription for a Schedule IT substance may not be refilled
218 (B) A Schedule II controlled substance may not be filled in a quantity to exceed a
219 one-months supply as directed on the daily dosage rate of the prescriptions
220 (ii) A Schedule ill or IV controlled substance may be filled only within six months of
221 issuance and may not be refilled more than six months after the date of its original issuance or
222 be refilled more than five times after the date of the prescription unless renewed by the
223 practitioner
224 (iii) All other controlled substances in Schedule V may be refilled as the prescribers
225 prescription directs but they may not be refilled one year after the date the prescription was
226 issued unless renewed by the practitioner
227 (iv) Any prescription for a Schedule IT substance may not be dispensed if it is not
228 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days
229 after the date the prescription was issued or 30 days after the dispensing date if that date is
230 specified separately from the date of issue
231 (v) A practitioner may issue more than one prescription at the same time for the same
232 Schedule IT controlled substance but only under the following conditions
233 (A) no more than three prescriptions for the same Schedule IT controlled substance may
234 be issued at the same time
235 (B) no one prescription may exceed a 30-day supply
236 (C) a second or third prescription shall include the date of issuance and the date for
237 dispensing and
238 (D) unless the practitioner determines there is a valid medical reason to the contrary
239 the date for dispensing a second or third prescription may not be fewer than 30 days from the
240 dispensing date of the previous prescription
241 [(1i) Each prescription rot a controlled snbstance may eontain only one controlled
242 substance per pIescription frlim and may not contain any other legend dmg 01 prescription
243 item]
244 (g) An order for a controlled substance in Schedules IT through V for use by an
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LEGISLATIVE GENERAL COUNSEL it Approved for Filing CJ Dupont it
HB114
it 02-06-14855 AM it
1 MAIL-ORDER WHOLESALE DRUG AMENDMENTS 2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Stewart Barlow
5 Senate Sponsor ______
6
7 LONG TITLE
8 General Description
9 This bill amends the Pharmacy Practice Act
10 Highlighted Provisions
11 This bill
12 ~ amends the definition of a class C pharmacy subject to regulation under the
13 Pharmacy Practice Act
14 Money Appropriated in this Bill
15 None
16 Other Special Clauses
17 This bi II takes effect on July 1 2014
18 Utah Code Sections Affected
19 AMENDS
20 58-17b-102 as last amended by Laws of Utah 2013 Chapters 52 166 and 423
21
22 Be it enacted by the Legislature ofthe state ofUtah
23 Section 1 Section 58-17b-102 is amended to read
24 58-17b-102 Definitions
25 In addition to the definitions in Section 58-1-102 as used in this chapter
26
27
(1) Administering means
(a) the direct application of a prescription drug or device whether by injection
==bull =bull
1111111111111111111111111111111111111111
02-06-14855 AM HB114
59 (9) Centralized prescription processing means the processing by a pharmacy of a
60 request from another pharmacy to fill or refill a prescription drug order or to perform
61 processing functions such as dispensing drug utilization review claims adjudication refill
62 authorizations and therapeutic interventions
63 (10) Class A pharmacy means a pharmacy located in Utah that is authorized as a
64 retail pharmacy to compound or dispense a drug or dispense a device to the public under a
65 prescription order
66 (11) Class B pharmacy
67 (a) means a pharmacy located in Utah
68 (i) that is authorized to provide pharmaceutical care for patients in an institutional
69 setting and
70 (ii) whose primary purpose is to provide a physical environment for patients to obtain
71 health care services and
72 (b) (i) includes closed-door hospital clinic nuclear and branch pharmacies and
73 (ii) pharmaceutical administration and sterile product preparation facilities
74 (12) Class C pharmacy means a pharmacy [located ill Utah that is anthOl ized to
75 engage] that engages in the manufacture production wholesale or distribution of drugs or
76 devices in Utah
77 (13) Class D pharmacy means a nonresident pharmacy
78 (14) Class E pharmacy means all other pharmacies
79 (15) Closed-door pharmacy means a pharmacy that provides pharmaceutical care to a
80 defined and exclusive group of patients who have access to the services of the pharmacy
81 because they are treated by or have an affiliation with a specific entity including a health
82 maintenance organization or an infusion company but not including a hospital pharmacy a
83 retailer of goods to the general public or the office of a practitioner
84 (16) Collaborative pharmacy practice means a practice of pharmacy whereby one or
85 more pharmacists have jointly agreed on a voluntary basis to work in conjunction with one or
86 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical
87 care functions authorized by the practitioner or practitioners under certain specified conditions
88 or limitations
89 (17) Collaborative pharmacy practice agreement means a written and signed
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02-06-14855 AM HB114
369 and
370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in
371 collaboration with the board
372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501
373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and
374 may be further defined by rule
375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that
376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration
377 for animals
378 Section 2 Effective date
379 This bill takes effect on July I 2014
Legislative Review Note as of 2-4-14 1243 PM
Office of Legislative Research and General Counsel
- 13 shy
LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t
t 02-05-14 122PM t
1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG
2 AMENDMENTS
3 2014 GENERAL SESSION
4 STATE OF UTAH
5 Chief Sponsor Stewart Barlow
6 Senate Sponsor
7
8 LONG TITLE
9 General Description
10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from
11 its licensing requirements under certain circumstances
12 Highlighted Provisions
13 This bill
14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy
15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an
16 employer sponsored clinic and complies with other requirements
17 repeals subject to sunset review the provisions of this bill relating to the exemption
18 described above and
19 ~ makes technical and conforming changes
20 Money Appropriated in this Bill
21 None
22 Other Special Clauses
23 None
24 Utah Code Sections Affected
25 AMENDS
26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~
27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull
1111111111111111111111111111111111111111
HBI06 02-05-14 122 PM
28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278
29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234
30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351
31 ENACTS
32 58-17b-3097 Utah Code Annotated 1953
33
34 Be it enacted by the Legislature ofthe state ofUtah
35 Section 1 Section 58-17b-301 is amended to read
36 58-17b-301 License required -- License classifications for individuals
37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the
38 practice of a pharmacy technician except as specifically provided in Section 58-1-307
39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097
40 (2) The division shall issue to an individual who qualifies under this chapter a license
41 in the classification of
42 (a) pharmacist
43 (b) pharmacy intern or
44 (c) pharmacy technician
45 Section 2 Section 58-17b-302 is amended to read
46 58-17b-302 License required -- License classifications for pharmacy facilities
47 (l) A license is required to act as a pharmacy except as specifically exempted from
48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or
49
50 (2) The division shall issue a pharmacy license to a facility that qualifies under this
51 chapter in the classification of a
52 (a) class A pharmacy
53 (b) class B pharmacy
54 (c) class C pharmacy
55 (d) class D pharmacy or
56 (e) class E pharmacy
57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist
58 at the same address a separate license shall be required for each pharmacy
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02-05-14 122 PM HBI06
59 (4) The division may further define or supplement the classifications of pharmacies
60 The division may impose restrictions upon classifications to protect the public health safety
61 and welfare
62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by
63 rule
64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy
65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities
66 of the pharmacy regardless of the form of the business organization
67 Section 3 Section 58-17b-309 is amended to read
68 58-17b-309 Exemptions from licensure
69 (l) [For ptnp05C5 of] As used in this section
70 (a) Cosmetic drug
71 (i) means a prescription drug that is
72 (A) for the purpose of promoting attractiveness or altering the appearance of an
73 individual and
74 (8) listed as a cosmetic drug subject to the exemption under this section by the division
75 by administrative rule or has been expressly approved for online dispensing whether or not it is
76 dispensed online or through a physicians office and
77 (ii) does not include a prescription drug that is
78 (A) a controlled substance
79 (8) compounded by the physician or
80 (C) prescribed or used for the patient for the purpose of diagnosing curing or
81 preventing a disease
82 (b) Injectable weight loss drug
83 (i) means an injectable prescription drug
84 (A) prescribed to promote weight loss and
85 (8) listed as an injectable prescription drug subject to exemption under this section by
86 the division by administrative rule and
87 (ii) does not include a prescription drug that is a controlled substance
88 (c) Prescribing practitioner means an individual licensed under
89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with
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HB106 02-05-14 122 PM
90 prescriptive practice
91 (ii) Chapter 67 Utah Medical Practice Act
92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or
93 (iv) Chapter 70a Physician Assistant Act
94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l
95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the
96 acts or practices described in this section without being licensed under this chapter
97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the
98 individual notifies the division in writing of the individuals intent to dispense a drug under this
99 [snbsectioll] Subsection (2)
100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1
101 (c) an individual engaging in the practice of pharmacy technician under the direct
102 personal supervision of a pharmacist while making satisfactory progress in an approved
103 program as defined in division rule
104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an
105 injectable weight loss drug to the prescribing practitioners patient in accordance with
106 Subsection (4) or
107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists
108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic
109 drug to the optometrists patient in accordance with Subsection (4)
110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under
111 Subsection (2)( c) must take all examinations as required by division rule following completion
112 of an approved curriculum of education within the required time frame This exemption
113 expires immediately upon notification of a failing score of an examination and the individual
114 may not continue working as a pharmacy technician even under direct supervision
115 (4) A prescribing practitioner or optometrist is exempt from licensing under the
116 provisions of this part if the prescribing practitioner or optometrist
117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the
118 authority to dispense under Subsection (4)(b) and
119 (ii) informs the patient
120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing
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HB106 02-05-14 122 PM
152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the
153 prescribing practitioners or optometrists office and determine if the provisions of this section
154 are being met by the prescribing practitioner or optometrist
155 (d) If a prescribing practitioner or optometrist violates a provision of this section the
156 prescribing practitioner or optometrist may be subject to discipline under
157 (i) this chapter and
158 (ii) (A) Chapter 16a Utah Optometry Practice Act
159 (B) Chapter 31 b Nurse Practice Act
160 (C) Chapter 67 Utah Medical Practice Act
161 (D) Chapter 68 Utah Osteopathic Medical Practice Act
162 (E) Chapter 70a Physician Assistant Act or
163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act
164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the
165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah
166 Optometry Practice Act
167 Section 4 Section 58-17b-3095 is amended to read
168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy
169 Division study of dispensing practitioners
170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen
171 (a) means a prescription drug used to treat cancer manage its symptoms or provide
172 continuity of care for a cancer patient
173 (b) includes
174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal
175 methods and
176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize
177 physical and psychological symptoms or pain or to improve patient tolerance of cancer
178 treatments or prepare a patient for a subsequent course of therapy and
179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug
180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections
181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt
182 from licensure under this chapter
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HB106 02-05-14 122 PM
214 (ii) is acting under the direction of a prescribing practitioner who is immediately
215 available on site for any necessary consultation and who has complied with Subsection
216 (2)(b)(i)
217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the
218 outpatient clinic setting and
219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)
220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to
221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section
222 (b) The evaluation under this Subsection (3) shall include
223 (i) practitioner compliance with the requirements of this section and Section
224 58-l7b-309
225 (ii) current research on dispensing and patient safety
226 (iii) survey of other state dispensing laws and
227 (iv) recommendations for future action concerning practitioner dispensing
228 (c) The division shall report to the Legislatures Health and Human Services Interim
229 Committee by November 302012 and by November 302013 with the results and
230 recommendations from the evaluation required by this Subsection (3)
231 (4) This section sunsets in accordance with Section 631-1-258
232 Section 5 Section 58-17b-3097 is enacted to read
233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an
234 employer sponsored clinic
235 (1) As used in this section
236 (a) Employer sponsored clinic means an entity that offers health care only to the
237 employees of an exclusive group of employers and the employees dependents
238 (b) Health care is as defined in Section 31 A-J-301
239 (c) Prepackaged drug means a prescription drug that
240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and
241 (ii) is packaged in a fixed quantity per package by
242 (A) the drug manufacturer
243 (B) a pharmaceutical wholesaler or distributor or
244 (C) a pharmacy licensed under this title
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~ -- -------------------
02-05-14 122 PM HB106
245 Cd) Prescribing practitioner is as defined in Section 58-17b-309
246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309
247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing
248 requirements of this chapter if the prescribing practitioner
249 Ca) treats an employee of one of an exclusive group of employers at an employer
250 sponsored clinic
251 Cb) prescribes a prepackaged drug to the employee
252 Cc) dispenses the prepackaged drug at the employer sponsored clinic
253 (d) notifies the division
254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the
255 employer sponsored clinic and
256 (ii) of the drug the prescribing practitioner intends to dispense
257 Ce) determines that providing the prepackaged drug to the employee at the employer
258 sponsored clinic is in the employees best interest
259 (f) informs the employee
260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner
261 from a pharmacy that is unaffiliated with the prescribing practitioner
262 (ii) of the directions for appropriate use of the prepackaged drug
263 (iii) of potential side effects to the use of the prepackaged drug and
264 (iv) how to contact the prescribing practitioner if the employee has questions or
265 concerns regarding the drug
266 (g) offers the employee the opportunity to consult with a pharmacist if the employee
267 asks for patient counseling and
268 (h) follows the administrative rules for a prescribing practitioner at an employer
269 sponsored clinic established by the division under Subsection (4)
270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a
271 prepackaged drug under this section requires physician supervision in its scope ofpractice
272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the
273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter
274 68 Utah Osteopathic Medical Practice Act
275 (4) The division shall in consultation with the board of pharmacy and the Physicians
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HBI06 02-05-14 122 PM
276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title
277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping
278 patient counseling purchasing and distribution operating treatment quality of care and
279 storage requirements for a prescribing practitioner at an employer sponsored clinic
280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a
281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing
282 practitioner is in compliance with this section
283 (6) If a prescribing practitioner violates a provision of this section the prescribing
284 practitioner may be subject to discipline under
285 (a) this chapter and
286 (b) any other chapter that governs the terms of the prescribing practitioners license
287 (7) The division shall evaluate the exemption created by this section and report to the
288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1
289 2018 on the results of the evaluation and the divisions recommendations regarding the
290 exemption
291 Section 6 Section 631-1-258 is amended to read
292 631-1-258 Repeal dates Title 58
293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is
294 repealed July 12016
295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015
296 (3) Section 58-17b-3095 is repealed July 1 2015
297 (4) Section 58-17b-3097 is repealed on July 12018
298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1
299 2018
300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1
301 2023
302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing
303 Act is repealed July 1 2019
304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1
305 2015
306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is
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02-05-14 1 22 PM HB106
307 repealed July 12023
308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1
309 2014
310 [ttej] ill) Section 58-69-3025 is repealed on July 12015
311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017
Legislative Review Note as of 2-3-14 418 PM
Office of Legislative Research and General Counsel
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Emergency Kit Compliance Overview Provided to DOPL on 2122014 by Jared Memmott
Emergency Kit Guidance from the American Society of Consultant Pharmacists
Question When is a nurse authorized to remove a controlled drug from an e-kit
Answer Controlled drugs in e-boxes are treated the some way as all other conrrolled drugs Before a drug can be removed there must be a volid written prescription Iwhich may be a fax unless the emergency exception applies E-boxes should never be used routinely to dispense drugs that should hove been reordered Raiher e-boxes should be used only for unanticipated emergendes that may be a new admission or a new order Due to the importance of state law in authorizing the use of eshykits in long-term care it is critical that practitioners pharmacists and facilities understond all pertishynent stole lows and regulotions governing e-kits in oddition to federal requirements
Question What are the potential consequences if nurse take a controlled drug from e-kit before the practitioner has issued a valid prescription
Answer Taking possession of a controlled drug without proper authorization con be a serious offense A nurse who removes a controlled drug from on e-kit without volid authorization may be subject to civil and criminal fines and penalties disciplinary action by the state licensing board and exclusion from federal health core programs
Question Is it permissible for a nurse to remove a controlled drug from an e-kit if slhe has received an oral order from the practitioner
Answer Some states permit this practice However DEA rules require that the practitioner provide oral authorization or a foxed prescription to the pharmacist before a drug is dispensed Consequently a practitioner who gives an oral order to the nurse in the facility by telephone must
also ensure that the pharmacy receives either an oral emergency order or a written prescription order (which may be sent via facsimile)
Question Can a nurse in a long-term care facility remove drugs from an E-kit based upon a standing order
Answer No An e-kit should only used in an emergency situation which by definition must be unanticipated
Question Can a nurse remove a CII from an e-kit for a patient who already has a valid prescription for a ell drug but has run out of medication at 200 am
Assuming this situation meets the criteria for an emergency situation the nurse would need to contact the practitioner for an orol authorization (which must be communicated by the pradifQner to the pharmacist either orally or by fax) While these situations sometimes cannot be avoided nursing facilities and pharmacies should hove systems in pJoce that ensure the timely reshyordering of medications for patients with on-going need for pain management
I bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull
Page 2 of 5
bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull
Emergency Kit Compliance Overview Provided to DOPL on 2122014 by Jared Memmott
Conflicts with Current Utah Statute
The Utah Controlled Substance Act in UCA sect 58-37-6 (2)(e) states
A separate license is reg uired at each principal place of business or professional practice where the applicant manufactures produces distributes dispenses conducts research with or performs laboratory analysis upon controlled substances
The Utah Pharmacy Practice Act in U CA sect 58-17b-302(3) states
Each place of business shall require a separate license If multiple pharmacies exist at the same address a separate license shall be required for each pharmacy
Conflicts with Current Utah Administrative Rules
R432 Health Family Health and Preparedness Licensing
Rule R432-1 50 Nursing Care Facility
R432-150-19 Pharmacy Services
(1) The facility must provide or obtain by contract routine and emergency drugs biologicals and pharmaceutical
services to meet resident needs
(2) The facility must employ or obtain the services of a licensed pharmacist who
(a) provides consultation on all aspects of pharmacy services in the facility
(b) establishes a system of records of receipt and disposition of all controlled substances which documents an
accurate reconciliation and
(c) determines that drug records are in order and that an account of all controlled substances is maintained and
reconciled monthly_
(3) The drug regimen of each resident must be reviewed at least once a month by a licensed pharmacist
(a) The pharmacist must report any irregularities to the attending physician and the director of nursing or health
services supervisor
(b) The physician and the director of Nursing or health services supervisor must indicate acceptance or rejection of
the report and document any action taken
(4) Pharmacy personnel must ensure that labels on drugs and biologicals are in accordance with currently accepted professional principles and include the appropriate accessory and cautionary instructions and the expiration date
(5) The facility must store all drugs and biologicals in locked compartments under proper temperature controls according to R432- I 50- I 9 (6)e) and permit only authorized personnel to have access to the keys
Page 3 of 5
Emergency Kit Compliance Overview Provided to DOPL on 2122014 by Jared Memmott
(a) The facility must provide separately locked permanently affixed compartments for storage of controlled substances listed in Schedule II of the Comprehensive Drug Abuse Prevention and Control Act of 1976 and other drugs subject to abuse except when the facility uses single unit dose package drug distribution systems in which the
quantity stored is minimal and a missing dose can be readily detected
(b) Non-medication materials that are poisonous or caustic may not be stored with medications
(c) Containers must be clearly labeled
(d) Medication intended for internal use shall be stored separately from medication intended for external use
(e) Medications stored at room temperature shall be maintained within 59 and 80 degrees F
() Refrigerated medications shall be maintained within 36 and 46 degrees F
(6) The facility must maintain an emergency drug supply
(a) Emergency drug containers shall be sealed to prevent unauthorized use
(b) Contents of the emergency drug supply must be listed on the outside of the container and the use of contents shall be documented by the nursing staff
(c) The emergency drug supply shall be stored and located for access by the nursing staff
(d) The pharmacist must inventory the emergency drug supply monthly
(e) Used or outdated items shall be replaced within 72 hours by the pharmacist
(7) The pharmacy must dispense and the facility must ensure that necessary drugs and biologicals are
provided on a timely basis
(8) The facility must limit the duration of a drug order in the absence of tbe prescribers specific
instructions
(9) Drug references must be available for all drugs used in the facility References shall include generic and brand
names available strength and dosage forms indications and side effects and other pharmacological data
(10) Drugs may be sent with the resident upon discharge if so ordered by the discharging physician provided
tbat
(a) such drugs are released in compliance R156-17a-619 and
(b) a record of the drugs sent with the resident is documented in the residents health record
(II) Disposal of controlled substances must be in accordance with the Pharmacy Practice Act
Page 4 of 5
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Emergency Kit Compliance Overview Provided to DOPL on 2122014 by Jared Memmott
IMPORTANT POINTS
~ The practice of pharmacy definition and the above described statute prohibit anyone other than a properly licensed pharmacy from possessing stock controlled substances or legend drugs
~The Utah Department of Health has invalid and antiquated administrative rules that supersedes what statute does not allow and existing pharmacy law and rule does not even address some of the operating standards mandated by the pharmacist and pharmacy who are providing pharmacy services
~As the Federal Register states that emergency kits in Long Term Care Facilities are only viewed as compliant with the Controlled Substance Act IF the appropriate state agency or regulatory authority specifically approves such placement anltLQ()lgates procedures which delineate The Utah Department of Health is not the appropriate state agency and moreover the appropriate Utah statute conflicts with the inappropriate state agency administrative rules
~ Additionally the existing administrative rules do not define and cover everything mandated in the Federal Register to even be considered compliant
Page 5 of 6
State of Utah Department of Comnlerce Division of Occupational and Professional Licensing
GARY R HERBERT FRANCINEA GIANI MARK B STEINAGEL GOlernnr Executive Director DiviSIOn Director
GUIDELINES FOR HOSPITAL PHARMACIES and EMERGENCY DEPARTMENT TREATMENT
Approved by the Board of Pharmacy May 21 2012
The pharmacist is responsible for all pharmacy practice as del ineated under Utah Code 58-17b and 58-37fto include
bull ordering receiving and stocking bull filling drug carts drug rooms emergency drug stocks bull controlling inventory including audit trail [or each controlled substance bull maintaining and adhering to policies and protocols that maintain controls over controlled
substances (Utah Controlled Substances Act Subsection R156-37-502 defines unprofessional conduct to include (4) failing to maintain controls over controlled substances which would be considered by a prudent practitioner to be effective against diversion theft or shortage of controlled substances (5) being unable to account for shortages of controlled substances for any controlled substance inventory for which the licensee has responsibility)
bull reviewing Medication Proof of Use forms or logs returned to the pharmacist for purposes of review and reconciliation and
bull submitting all required controlled substance prescription information to the Controlled Substance Database pursuant to Utah Code 58-37f-203
NOTE Responsible means accountable for The pharmacist may delegate the task yet is ultimately accountable for the outcome Final checks of medications or medication profiles cannot be delegated
After-hours Medications Taken from Pharmacy When a Pharmacy is Closed
Only a pharmacist nurse supervisor or charge nurse can enter the pharmacy when the bull pharmacy is closed Medications can only be taken from the pharmacy on an emergency as needed basis Abull medication log must be used to keep a per medication inventory Only a pharmacist nurse supervisor or charge nurse can have access and the alarm code bull to whel1_~ltj)armacL~19~~~alth0lglil~one~~tthe p(irmacist can _~~___ ~ have a key to the locked controlled substance inventory in the pharmacy The pharmacy must still be equipped with a security system to permit detection of entry at all times when the facility is closed An adequate security system for inpatient phannacies within hospitals would be a system similar to a badge reader access which could uniquely store and retain which authorized person had made entry into the pharmacy after regular hours
wwwdoplulahgoYmiddot Heber M Wells Buildingmiddot 160 East300 South PO Box 146741 Salt Lake City UT 84114-6741 telephone (801) 530-6628 bull tollmiddot free in Utah (866) 275-3675 bull fax (801) 530-651 1 bull investigations fax (801) 530middot630 I UTAH
Dispensing of Drugs from an Emergency Room
bull Emergency room staff including the prescribing practitioner or Iicensed nurse cannot dispense prescriptions to a patient The prescribing practitioner can give an emergency supply which is properly labeled to a patient to get a patient started on the medication until a pharmacy is open This is not to be construed to allow a prescribing practitioner to give out an entire prescription amount
The related community standard for the treatment of typical Emergency Department conditions and STI prophylaxis is seven days
bull Such emergency doses of medications shall be labelcd with at least -Prescribing practitioners name and facility name and telephone number -Patients name -Name ormedication and strength -Number oftablets given -Date given and -I nstrLlctions for use
bull Records of controlled substances dispensed by the prescribing practitioner must be provided to the pharmacy so that applicable prescription data can be reported to the CSD
NOTE Physicians may give out samples which are clearly marked as a sample not for resale unti I the patient can get to a pharmacy or to try the medication for possible untoward effects Samples must be dispensed pursuant to Utah Code Annotated sect 58shy17b-610
Repackaging bull It is illegal for retail phannacies to repackage medications for resale to hospitals clinics
or other pharmacies The hospital pharmacy could legally repackage medications for use in its own institution
Federal Statute
According to Federal regulations repackaging requires a manufacturers license as stated in US Code 21-130001(27) and USC 21-1301lI(a)
USC 21-130001 reads Manufacture means the producing preparation propagation compounding or processing of a drug or other substance or the packaging or repackaging of such substance or the labeling or relabeling of the commercial container of such substance but
~----- middotmiddotmiddotmiddot_~aoesmmiddotnot IncluOelne-aCliiities omiddotf-a-praclilioifef-wlio~middotasan1nci(rentwhlS1hmiddoteraoffilnistratle)ffT5f-
dispensing such substance in the course of hisher professional practice prepares compounds packages or labels such substance
USC 21-130111 (a) reads Every person who manufactures distributes dispenses imports or exports any controlled substances or who proposes to engage in the manufacture distribution dispensing importation or exportation of any controlled substances shall obtain a registration
wwwdoptutahgovmiddot Heber M Wells Buildingmiddot 160 East 300 Southmiddot PO Box 146741 Salt Lake City UT 84114-6741 telephone (801) 530-6628middot toll-free in Utah (866) 275-3675 fax (801) 530-6511 investigations fax (801) 530-6301
LEGISLA TIVE GENERAL COUNSEL SB178 ct Approved for Filing Sc Allred ct
ct 02-05-14 1 56 PM ct
1 CONTROLLED SUBSTANCE DATABASE MODIFICATIONS
2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Evan J Vickers
5 House Sponsor Bradley G Last
6
7 LONG TITLE
8 General Description
9 This bill modifies the Controlled Substance Database Act regarding access by pharmacy
10 technicians
11 Highlighted Provisions
12 This bill
13 ~ allows the phannacist-in-charge to designate a licensed phannacy technician to have
14 access to the database on behalf of the phannacist in accordance with statutory
15 requirements
16 Money Appropriated in this Bill
17 None
18 Other Special Clauses
19 None
20 Utah Code Sections Affected
21 AMENDS
22 58-37fmiddot301 as last amended by Laws of Utah 2013 Chapters 12 130 and 262
23
24 Be it enacted by the Legislature ofthe state ofUtah
25
26
27
Section 1 Section 58-37fmiddot301 is amended to read
58-37fmiddot301 Access to database
(1) The division shall make rules in accordance with Title 63G Chapter 3 Utah
rJlbull =bull
1111111111111111111111111111111111111111
02-05-14 156 PM SB178
59 (A) fit within the responsibilities of the Department of Health for health and welfare
60 (B) are reviewed and approved by an Institutional Review Board that is approved for
61 human subject research by the United States Department of Health and Human Services and
62 (C) are not conducted for profit or commercial gain and
63 (D) are conducted in a research facility as defined by division rule that is associated
64 with a university or college in the state accredited by the Northwest Commission on Colleges
65 and Universities
66 (iii) the designee protects the information as a business associate of the Department of
67 Health and
68 (iv) the identity of the prescribers patients and pharmacies in the database are
69 de-identified confidential not disclosed in any manner to the designee or to any individual
70 who is not directly involved in the scientific studies
71 (e) a licensed practitioner having authority to prescribe controlled substances to the
72 extent the information
73 (i) (A) relates specifically to a current or prospective patient of the practitioner and
74 (B) is provided to or sought by the practitioner for the purpose of
75 (I) prescribing or considering prescribing any controlled substance to the current or
76 prospective patient
77 (II) diagnosing the current or prospective patient
78 (nn providing medical treatment or medical advice to the current or prospective
79 patient or
80 (IV) determining whether the current or prospective patient
81 (Aa) is attempting to fraudulently obtain a controlled substance from the practitioner
82 or
83 (Bb) has fraudulently obtained or attempted to fraudulently obtain a controlled
84 substance from the practitioner
85 (ii) (A) relates specifically to a fonner patient of the practitioner and
86 (B) is provided to or sought by the practitioner for the purpose of determining whether
87 the former patient has fraudulently obtained or has attempted to fraudulently obtain a
88 controlled substance from the practitioner
89 (iii) relates specifically to an individual who has access to the practitioners Drug
- 3 shy
02-05-14 156 PM SB178
121 58-3 7f-203(3 )(b) with respect to the employee
122 (h) a licensed pharmacist having authority to dispense a controlled substance to the
123 extent the information is provided or sought for the purpose of
124 (i) dispensing or considering dispensing any controlled substance or
125 (ii) determining whether a person
126 (A) is attempting to fraudulently obtain a controlled substance from the pharmacist or
127 (B) has fraudulently obtained or attempted to fraudulently obtain a controlled
128 substance from the pharmacist
129 (i) in accordance with Subsection (3)(a) a licensed pharmacy technician who is an
]30 employee of a pharmacy as defined in Section 58-17b-l 02 for the purposes described in
131 Subsection (2)(h)(i) or (iO if
132 0) the employee is designated by the pharmacist-in-charge as an individual authorized
133 to access the information on behalf of a licensed pharmacist employed by the pharmacy
134 (ii) the pharmacist-in-charge provides written notice to the division of the identity of
135 the employee and
136 (iii) the division
137 CA) grants the employee access to the database and
138 (B) provides the employee with a password that is unique to that employee to access
139 the database in order to permit the division to comply with the requirements of Subsection
140 58-37f-203(3)(b) with respect to the employee
141 [fiJ] ill federal state and local law enforcement authorities and state and local
142 prosecutors engaged as a specified duty of their employment in enforcing laws
143 (i) regulating controlled substances
144 (ii) investigating insurance fraud Medicaid fraud or Medicare fraud or
145 (iii) providing information about a criminal defendant to defense counsel upon request
146 during the discovery process for the purpose of establishing a defense in a criminal case
147 [61] fhl employees ofthe Office oflntemal Audit and Program Integrity within the
148 Department of Health who are engaged in their specified duty of ensuring Medicaid program
149 integrity under Section 26-18-23
150 [fki] ill a mental health therapist if
151 (i) the information relates to a patient who is
- 5 shy
02-05-14 156 PM SB178
183 designated under Subsection (2)(f) (2)(g) or (4)(c) should be granted access to the database
184 and
185 (ii) establish the information to be provided by an emergency room employee under
186 Subsection (4)
187 (c) The division shall grant an employee designated under Subsection (2)(f) (2)(g) or
188 (4)( c) access to the database unless the division determines based on a background check that
189 the employee poses a security risk to the information contained in the database
190 (4) (a) An individual who is employed in the emergency room ofa hospital may
191 exercise access to the database under this Subsection (4) on behalf of a licensed practitioner if
192 the individual is designated under Subsection (4)( c) and the licensed practitioner
193 (i) is employed in the emergency room
194 Oi) is treating an emergency room patient for an emergency medical condition and
195 (iii) requests that an individual employed in the emergency room and designated under
196 Subsection (4)( c) obtain information regarding the patient from the database as needed in the
197 course of treatment
198 (b) The emergency room employee obtaining information from the database shall
199 when gaining access to the database provide to the database the name and any additional
200 identifiers regarding the requesting practitioner as required by division administrative rule
201 established under Subsection (3)(b)
202 (c) An individual employed in the emergency room under this Subsection (4) may
203 obtain information from the database as provided in Subsection (4)(a) if
204 (i) the employee is designated by the practitioner as an individual authorized to access
205 the information on behalf of the practitioner
206 (ii) the practitioner and the hospital operating the emergency room provide written
207 notice to the division of the identity of the designated employee and
208 (iii) the division
209 (A) grants the employee access to the database and
210 (B) provides the employee with a password that is unique to that employee to access
211 the database in order to permit the division to comply with the requirements of Subsection
212 58-37f-203(3)(b) with respect to the employee
213 (d) The division may impose a fee in accordance with Section 63J-I-504 on a
- 7
LEGISLATIVE GENERAL C01JNSEL SB55 iL Approved for Filing Cl Dupont iL lst Sub (Green)
iL 02-07-14 416 PM iL
Senator Evan J Vickers proposes the following substitute bill
PHARMACEUTICAL DISPENSING AMENDMENTS
2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Evan J Vickers
5 House Sponsor Stewart Barlow
6
7 LONG TITLE
8 General Description
9 This bill amends the Pharmacy Practice Act to create a dispensing medical practitioner
10 license and a license classification for a dispensing medical practitioner clinic
11 pharmacy
12 Highlighted Provisions
13 This bill
14 defines terms
15 establishes the license classification dispensing medical practitioner under the
16 Pharmacy Practice Act for medical practitioners who prescribe and dispense a drug
17 establishes the pharmacy facility license classification dispensing medical
18 practitioner clinic pharmacy under the Pharmacy Practice Act
19 creates Part 8 Dispensing Medical Practitioner and Dispensing Medical Practitioner
20 Clinic Pharmacy
21 removes the exemption from the Pharmacy Practice Act for medical practitioners
22 who prescribe and dispense a cosmetic drug injectable weight loss drug or a cancer
23 drug treatment regimen
24 requires a license as a dispensing medical practitioner for a health care practitioner 00
25 to dispense bull bull=
1111111111111111111111111111111111111111111111111111111
02-07-14 416 PM 1st Sub (Green) SB 55
615 Practitioner Clinic Pharmacy II
616 Section 8 Section 58-17b-802 is enacted to read
617 58-17b-802 Definitions
618 As used in this part
619 (1) (a) Cosmetic drug means a prescription drug that
620 (i) is for the purpose of promoting attractiveness or altering the appearance of an
621 individual and
622 (ii) (A) is listed as a cosmetic drug subject to the exemption under this section by the
623 division by administrative rule or
624 CB) has been expressly approved for online dispensing whether or not it is dispensed
625 online or through a physicians office
626 (b) Cosmetic drug does not include a prescription drug that is
627 (i) a controlled substance
628 (ii) compounded by the physician or
629 (iii) prescribed or used for the patient for the purpose of diagnosing curing or
630 preventing a disease
631 (2) Employer sponsored clinic means an entity that S-t has a medical director who is
631 a licensed as a physician as defined in Section 58-67-102 and S offers health care only to the
632 employees of an exclusive group of employers and the employees dependents
633 (3) Health care is as defined in Section 31A-1-301
634 (4) Ca) Injectable weight loss drug means an injectable prescription drug
635 (n prescribed to promote weight loss and
636 (ii) listed as an injectable prescription drug subject to exemption under this section by
637 the division by administrative rule
638 (b) Injectable weight loss drug does not include a prescription drug that is a
639 controlled substance
640 (5) Prepackaged drug means a prescription drug that
641 (a) is not listed under federal or state law as a Schedule I II ill IV or V drug and
642 (b) is packaged in a fixed quantity per package by
643 (i) the drug manufacturer
644 (ii) a pharmaceutical wholesaler or distributor or
645 (iii) a pharmacy licensed under this title
- 21 Senate Committee Amendments 2-13-2014 Jplcjd
1st Sub (Green) SB 55 02-07-14 416 PM
646 Section 9 Section 58-17b-803 is enacted to read
647 58-17b-803 Qualifications for licensure as a dispensing medical practitioner -shy
648 Scope of practice
649 (1) An applicant for a license as a dispensing medical practitioner shall
650 (a) be licensed in good standing under at least one of the chapters listed in Subsection
651 58-17b-l02(23)(a) and
652 (b) submit an application for a license as a dispensing medical practitioner in a form
653 prescribed by the division and pay a fee established by the S [depal tment] divisionS ~
654 (2) The division shall accept the licensing in good standing under Subsection (1) in lieu
655 of requiring an applicant for a license under this part to comply with Sections 58-17b-303 and
656
657 (3) A dispensing medical practitioner may dispense in accordance with this part
658 (a) a cosmetic drug and an injectable weight loss drug if
659 (i) the drug was prescribed by the dispensing medical practitioner to the dispensing
660 medical practitioners patient and
661 Oi) the dispensing medical practitioner complies with administrative rules adopted by
662 the division under Subsection 58-17-802(1)
663 (b) a cancer drug treatment regimen if the dispensing medical practitioner complies
664 with Section 58-17b-805 and
665 (c) a pre-packaged drug to an employee or a dependent of an employee at an employer
666 sponsored clinic if the dispensing medical practitioner
667 (i) treats an employee or the dependent of an employee of one of an exclusive group
668 of employers at an employer sponsored clinic
669 (ii) prescribes a prepackaged drug to the employee or the employees dependent
670 (iii) dispenses the prepackaged drug at the employer sponsored clinic and
671 (iv) complies with administrative rules adopted by the division in consultation with the
672 Board of Pharmacy that establish labeling record keeping patient counseling purchasing and
673 distribution operating treatment quality of care and storage requirements
674 (4) A dispensing medical practitioner
675 Ca) shall inform the patient
676 (i) that the drug dispensed by the practitioner may be obtained from a pharmacy
- 22 - Senate Committee Amendments 2-13-2014 picjd
02-07-14 416 PM 1st Sub (Green) SB 55
739 58-17b-806 Dispensing medical practitioner -- Dispensing medical practitioner
740 clinic pharmacy -- Unprofessional and Unlawful conduct
741 ill S Ull S The division S [ iii consultation witb tile boal d shall
742 (a) I epol t a violation of this chapter b a dispensing medical pi actitiollel to] shall consult
742a with S the
743 dispensing medical practitioners appropriate licensing board as designated in Subsection
744 5S-17b-l02(23)(a) S reeardine a violation oftMs chapterS and
745 (hl S the Pharmacy Board shall if requested by the licensine board of the dispensine
745a medical practitionerS assist the licensing board for the dispensing medical practitioner with
745b reviewing the
746 violations of the provisions of this chapter
747 (2) The division S [ in collabOi atioll with the Boal d ofPhall1l3C]S may take
747a appropriate
748 action against a dispensing medical practitioner in accordance with this chapter if the
749 licensing board designated in Subsection 58-17b- 02(23)(a) recommends to the division that
750 action be taken under this chapter
751 (3) The division in consultation with the board is the primary enforcer under this
752 chapter for a dispensing medical practitioner clinic pharmacy licensed under Section
753 58-17b-804
754 Section 13 Section 58-31b-502 is amended to read
755 58-31b-502 Unprofessional conduct
756 Unprofessional conduct includes
757 (l) failure to safeguard a patients right to privacy as to the patients person condition
758 diagnosis personal effects or any other matter about which the licensee is privileged to know
759 because of the licensees or person with a certifications position or practice as a nurse or
760 practice as a medication aide certified
761 (2) failure to provide nursing service or service as a medication aide certified in a
762 manner that demonstrates respect for the patients human dignity and unique personal character
763 and needs without regard to the patients race religion ethnic background socioeconomic
764 status age sex or the nature of the patients health problem
765 (3) engaging in sexual relations with a patient during any
766 (a) period when a generally recognized professional relationship exists between the
767 person licensed or certified under this chapter and patient or
768 (b) extended period when a patient has reasonable cause to believe a professional
769 relationship exists between the person licensed or certified under the provisions of this chapter
- 25 - Senate Committee Amendments 2-13-2014Iplcjd
LEGISLA TIVE GENERAL COUNSEL SB138 ct Approved for Filing Sc Allred ct
ct 02-04-14 1220 PM ct
1 CONTROLLED SUBSTANCES ACT AMENDMENTS
2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Evan J Vickers
5 House Sponsor Stewart Barlow
6
7 LONG TITLE
8 General Description
9 This bill modifies the Utah Controlled Substances Act regarding prescriptions for
10 controlled substances
11 Highlighted Provisions
12 This bill
13 ~ provides that more than one controlled substance may be included in a prescription
14 Money Appropriated in this Bill
15 None
16 Other Special Clauses
17 None
18 Utah Code Sections Affected
19 AMENDS
20 58-37-6 as last amended by Laws of Utah 2012 Chapter 272
21
22 Be it enacted by the Legislature of the state ofUtah
23 Section 1 Section 58-37-6 is amended to read
24 58-37-6 License to manufacture produce distribute dispense administer or
25 conduct research -- Issuance by division -- Denial suspension or revocation -- Records
26
27
required -- Prescriptions
(1) (a) The division may adopt rules relating to the licensing and control of the bull
1111111111111111111111111111111111111111
SB138 02-04-14 1220 PM
214 (ii) the prescribed controlled substance is to be used in research
215 (f) Except when administered directly to an ultimate user by a licensed practitioner
216 controlled substances are subject to the following restrictions
217 (i) (A) A prescription for a Schedule IT substance may not be refilled
218 (B) A Schedule II controlled substance may not be filled in a quantity to exceed a
219 one-months supply as directed on the daily dosage rate of the prescriptions
220 (ii) A Schedule ill or IV controlled substance may be filled only within six months of
221 issuance and may not be refilled more than six months after the date of its original issuance or
222 be refilled more than five times after the date of the prescription unless renewed by the
223 practitioner
224 (iii) All other controlled substances in Schedule V may be refilled as the prescribers
225 prescription directs but they may not be refilled one year after the date the prescription was
226 issued unless renewed by the practitioner
227 (iv) Any prescription for a Schedule IT substance may not be dispensed if it is not
228 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days
229 after the date the prescription was issued or 30 days after the dispensing date if that date is
230 specified separately from the date of issue
231 (v) A practitioner may issue more than one prescription at the same time for the same
232 Schedule IT controlled substance but only under the following conditions
233 (A) no more than three prescriptions for the same Schedule IT controlled substance may
234 be issued at the same time
235 (B) no one prescription may exceed a 30-day supply
236 (C) a second or third prescription shall include the date of issuance and the date for
237 dispensing and
238 (D) unless the practitioner determines there is a valid medical reason to the contrary
239 the date for dispensing a second or third prescription may not be fewer than 30 days from the
240 dispensing date of the previous prescription
241 [(1i) Each prescription rot a controlled snbstance may eontain only one controlled
242 substance per pIescription frlim and may not contain any other legend dmg 01 prescription
243 item]
244 (g) An order for a controlled substance in Schedules IT through V for use by an
- 8 shy
LEGISLATIVE GENERAL COUNSEL it Approved for Filing CJ Dupont it
HB114
it 02-06-14855 AM it
1 MAIL-ORDER WHOLESALE DRUG AMENDMENTS 2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Stewart Barlow
5 Senate Sponsor ______
6
7 LONG TITLE
8 General Description
9 This bill amends the Pharmacy Practice Act
10 Highlighted Provisions
11 This bill
12 ~ amends the definition of a class C pharmacy subject to regulation under the
13 Pharmacy Practice Act
14 Money Appropriated in this Bill
15 None
16 Other Special Clauses
17 This bi II takes effect on July 1 2014
18 Utah Code Sections Affected
19 AMENDS
20 58-17b-102 as last amended by Laws of Utah 2013 Chapters 52 166 and 423
21
22 Be it enacted by the Legislature ofthe state ofUtah
23 Section 1 Section 58-17b-102 is amended to read
24 58-17b-102 Definitions
25 In addition to the definitions in Section 58-1-102 as used in this chapter
26
27
(1) Administering means
(a) the direct application of a prescription drug or device whether by injection
==bull =bull
1111111111111111111111111111111111111111
02-06-14855 AM HB114
59 (9) Centralized prescription processing means the processing by a pharmacy of a
60 request from another pharmacy to fill or refill a prescription drug order or to perform
61 processing functions such as dispensing drug utilization review claims adjudication refill
62 authorizations and therapeutic interventions
63 (10) Class A pharmacy means a pharmacy located in Utah that is authorized as a
64 retail pharmacy to compound or dispense a drug or dispense a device to the public under a
65 prescription order
66 (11) Class B pharmacy
67 (a) means a pharmacy located in Utah
68 (i) that is authorized to provide pharmaceutical care for patients in an institutional
69 setting and
70 (ii) whose primary purpose is to provide a physical environment for patients to obtain
71 health care services and
72 (b) (i) includes closed-door hospital clinic nuclear and branch pharmacies and
73 (ii) pharmaceutical administration and sterile product preparation facilities
74 (12) Class C pharmacy means a pharmacy [located ill Utah that is anthOl ized to
75 engage] that engages in the manufacture production wholesale or distribution of drugs or
76 devices in Utah
77 (13) Class D pharmacy means a nonresident pharmacy
78 (14) Class E pharmacy means all other pharmacies
79 (15) Closed-door pharmacy means a pharmacy that provides pharmaceutical care to a
80 defined and exclusive group of patients who have access to the services of the pharmacy
81 because they are treated by or have an affiliation with a specific entity including a health
82 maintenance organization or an infusion company but not including a hospital pharmacy a
83 retailer of goods to the general public or the office of a practitioner
84 (16) Collaborative pharmacy practice means a practice of pharmacy whereby one or
85 more pharmacists have jointly agreed on a voluntary basis to work in conjunction with one or
86 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical
87 care functions authorized by the practitioner or practitioners under certain specified conditions
88 or limitations
89 (17) Collaborative pharmacy practice agreement means a written and signed
- 3 shy
02-06-14855 AM HB114
369 and
370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in
371 collaboration with the board
372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501
373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and
374 may be further defined by rule
375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that
376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration
377 for animals
378 Section 2 Effective date
379 This bill takes effect on July I 2014
Legislative Review Note as of 2-4-14 1243 PM
Office of Legislative Research and General Counsel
- 13 shy
LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t
t 02-05-14 122PM t
1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG
2 AMENDMENTS
3 2014 GENERAL SESSION
4 STATE OF UTAH
5 Chief Sponsor Stewart Barlow
6 Senate Sponsor
7
8 LONG TITLE
9 General Description
10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from
11 its licensing requirements under certain circumstances
12 Highlighted Provisions
13 This bill
14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy
15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an
16 employer sponsored clinic and complies with other requirements
17 repeals subject to sunset review the provisions of this bill relating to the exemption
18 described above and
19 ~ makes technical and conforming changes
20 Money Appropriated in this Bill
21 None
22 Other Special Clauses
23 None
24 Utah Code Sections Affected
25 AMENDS
26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~
27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull
1111111111111111111111111111111111111111
HBI06 02-05-14 122 PM
28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278
29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234
30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351
31 ENACTS
32 58-17b-3097 Utah Code Annotated 1953
33
34 Be it enacted by the Legislature ofthe state ofUtah
35 Section 1 Section 58-17b-301 is amended to read
36 58-17b-301 License required -- License classifications for individuals
37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the
38 practice of a pharmacy technician except as specifically provided in Section 58-1-307
39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097
40 (2) The division shall issue to an individual who qualifies under this chapter a license
41 in the classification of
42 (a) pharmacist
43 (b) pharmacy intern or
44 (c) pharmacy technician
45 Section 2 Section 58-17b-302 is amended to read
46 58-17b-302 License required -- License classifications for pharmacy facilities
47 (l) A license is required to act as a pharmacy except as specifically exempted from
48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or
49
50 (2) The division shall issue a pharmacy license to a facility that qualifies under this
51 chapter in the classification of a
52 (a) class A pharmacy
53 (b) class B pharmacy
54 (c) class C pharmacy
55 (d) class D pharmacy or
56 (e) class E pharmacy
57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist
58 at the same address a separate license shall be required for each pharmacy
-2shy
02-05-14 122 PM HBI06
59 (4) The division may further define or supplement the classifications of pharmacies
60 The division may impose restrictions upon classifications to protect the public health safety
61 and welfare
62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by
63 rule
64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy
65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities
66 of the pharmacy regardless of the form of the business organization
67 Section 3 Section 58-17b-309 is amended to read
68 58-17b-309 Exemptions from licensure
69 (l) [For ptnp05C5 of] As used in this section
70 (a) Cosmetic drug
71 (i) means a prescription drug that is
72 (A) for the purpose of promoting attractiveness or altering the appearance of an
73 individual and
74 (8) listed as a cosmetic drug subject to the exemption under this section by the division
75 by administrative rule or has been expressly approved for online dispensing whether or not it is
76 dispensed online or through a physicians office and
77 (ii) does not include a prescription drug that is
78 (A) a controlled substance
79 (8) compounded by the physician or
80 (C) prescribed or used for the patient for the purpose of diagnosing curing or
81 preventing a disease
82 (b) Injectable weight loss drug
83 (i) means an injectable prescription drug
84 (A) prescribed to promote weight loss and
85 (8) listed as an injectable prescription drug subject to exemption under this section by
86 the division by administrative rule and
87 (ii) does not include a prescription drug that is a controlled substance
88 (c) Prescribing practitioner means an individual licensed under
89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with
- 3 shy
HB106 02-05-14 122 PM
90 prescriptive practice
91 (ii) Chapter 67 Utah Medical Practice Act
92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or
93 (iv) Chapter 70a Physician Assistant Act
94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l
95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the
96 acts or practices described in this section without being licensed under this chapter
97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the
98 individual notifies the division in writing of the individuals intent to dispense a drug under this
99 [snbsectioll] Subsection (2)
100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1
101 (c) an individual engaging in the practice of pharmacy technician under the direct
102 personal supervision of a pharmacist while making satisfactory progress in an approved
103 program as defined in division rule
104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an
105 injectable weight loss drug to the prescribing practitioners patient in accordance with
106 Subsection (4) or
107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists
108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic
109 drug to the optometrists patient in accordance with Subsection (4)
110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under
111 Subsection (2)( c) must take all examinations as required by division rule following completion
112 of an approved curriculum of education within the required time frame This exemption
113 expires immediately upon notification of a failing score of an examination and the individual
114 may not continue working as a pharmacy technician even under direct supervision
115 (4) A prescribing practitioner or optometrist is exempt from licensing under the
116 provisions of this part if the prescribing practitioner or optometrist
117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the
118 authority to dispense under Subsection (4)(b) and
119 (ii) informs the patient
120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing
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HB106 02-05-14 122 PM
152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the
153 prescribing practitioners or optometrists office and determine if the provisions of this section
154 are being met by the prescribing practitioner or optometrist
155 (d) If a prescribing practitioner or optometrist violates a provision of this section the
156 prescribing practitioner or optometrist may be subject to discipline under
157 (i) this chapter and
158 (ii) (A) Chapter 16a Utah Optometry Practice Act
159 (B) Chapter 31 b Nurse Practice Act
160 (C) Chapter 67 Utah Medical Practice Act
161 (D) Chapter 68 Utah Osteopathic Medical Practice Act
162 (E) Chapter 70a Physician Assistant Act or
163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act
164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the
165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah
166 Optometry Practice Act
167 Section 4 Section 58-17b-3095 is amended to read
168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy
169 Division study of dispensing practitioners
170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen
171 (a) means a prescription drug used to treat cancer manage its symptoms or provide
172 continuity of care for a cancer patient
173 (b) includes
174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal
175 methods and
176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize
177 physical and psychological symptoms or pain or to improve patient tolerance of cancer
178 treatments or prepare a patient for a subsequent course of therapy and
179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug
180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections
181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt
182 from licensure under this chapter
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HB106 02-05-14 122 PM
214 (ii) is acting under the direction of a prescribing practitioner who is immediately
215 available on site for any necessary consultation and who has complied with Subsection
216 (2)(b)(i)
217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the
218 outpatient clinic setting and
219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)
220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to
221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section
222 (b) The evaluation under this Subsection (3) shall include
223 (i) practitioner compliance with the requirements of this section and Section
224 58-l7b-309
225 (ii) current research on dispensing and patient safety
226 (iii) survey of other state dispensing laws and
227 (iv) recommendations for future action concerning practitioner dispensing
228 (c) The division shall report to the Legislatures Health and Human Services Interim
229 Committee by November 302012 and by November 302013 with the results and
230 recommendations from the evaluation required by this Subsection (3)
231 (4) This section sunsets in accordance with Section 631-1-258
232 Section 5 Section 58-17b-3097 is enacted to read
233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an
234 employer sponsored clinic
235 (1) As used in this section
236 (a) Employer sponsored clinic means an entity that offers health care only to the
237 employees of an exclusive group of employers and the employees dependents
238 (b) Health care is as defined in Section 31 A-J-301
239 (c) Prepackaged drug means a prescription drug that
240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and
241 (ii) is packaged in a fixed quantity per package by
242 (A) the drug manufacturer
243 (B) a pharmaceutical wholesaler or distributor or
244 (C) a pharmacy licensed under this title
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~ -- -------------------
02-05-14 122 PM HB106
245 Cd) Prescribing practitioner is as defined in Section 58-17b-309
246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309
247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing
248 requirements of this chapter if the prescribing practitioner
249 Ca) treats an employee of one of an exclusive group of employers at an employer
250 sponsored clinic
251 Cb) prescribes a prepackaged drug to the employee
252 Cc) dispenses the prepackaged drug at the employer sponsored clinic
253 (d) notifies the division
254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the
255 employer sponsored clinic and
256 (ii) of the drug the prescribing practitioner intends to dispense
257 Ce) determines that providing the prepackaged drug to the employee at the employer
258 sponsored clinic is in the employees best interest
259 (f) informs the employee
260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner
261 from a pharmacy that is unaffiliated with the prescribing practitioner
262 (ii) of the directions for appropriate use of the prepackaged drug
263 (iii) of potential side effects to the use of the prepackaged drug and
264 (iv) how to contact the prescribing practitioner if the employee has questions or
265 concerns regarding the drug
266 (g) offers the employee the opportunity to consult with a pharmacist if the employee
267 asks for patient counseling and
268 (h) follows the administrative rules for a prescribing practitioner at an employer
269 sponsored clinic established by the division under Subsection (4)
270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a
271 prepackaged drug under this section requires physician supervision in its scope ofpractice
272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the
273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter
274 68 Utah Osteopathic Medical Practice Act
275 (4) The division shall in consultation with the board of pharmacy and the Physicians
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HBI06 02-05-14 122 PM
276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title
277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping
278 patient counseling purchasing and distribution operating treatment quality of care and
279 storage requirements for a prescribing practitioner at an employer sponsored clinic
280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a
281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing
282 practitioner is in compliance with this section
283 (6) If a prescribing practitioner violates a provision of this section the prescribing
284 practitioner may be subject to discipline under
285 (a) this chapter and
286 (b) any other chapter that governs the terms of the prescribing practitioners license
287 (7) The division shall evaluate the exemption created by this section and report to the
288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1
289 2018 on the results of the evaluation and the divisions recommendations regarding the
290 exemption
291 Section 6 Section 631-1-258 is amended to read
292 631-1-258 Repeal dates Title 58
293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is
294 repealed July 12016
295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015
296 (3) Section 58-17b-3095 is repealed July 1 2015
297 (4) Section 58-17b-3097 is repealed on July 12018
298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1
299 2018
300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1
301 2023
302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing
303 Act is repealed July 1 2019
304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1
305 2015
306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is
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02-05-14 1 22 PM HB106
307 repealed July 12023
308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1
309 2014
310 [ttej] ill) Section 58-69-3025 is repealed on July 12015
311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017
Legislative Review Note as of 2-3-14 418 PM
Office of Legislative Research and General Counsel
- 11 shy
bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull
Emergency Kit Compliance Overview Provided to DOPL on 2122014 by Jared Memmott
Conflicts with Current Utah Statute
The Utah Controlled Substance Act in UCA sect 58-37-6 (2)(e) states
A separate license is reg uired at each principal place of business or professional practice where the applicant manufactures produces distributes dispenses conducts research with or performs laboratory analysis upon controlled substances
The Utah Pharmacy Practice Act in U CA sect 58-17b-302(3) states
Each place of business shall require a separate license If multiple pharmacies exist at the same address a separate license shall be required for each pharmacy
Conflicts with Current Utah Administrative Rules
R432 Health Family Health and Preparedness Licensing
Rule R432-1 50 Nursing Care Facility
R432-150-19 Pharmacy Services
(1) The facility must provide or obtain by contract routine and emergency drugs biologicals and pharmaceutical
services to meet resident needs
(2) The facility must employ or obtain the services of a licensed pharmacist who
(a) provides consultation on all aspects of pharmacy services in the facility
(b) establishes a system of records of receipt and disposition of all controlled substances which documents an
accurate reconciliation and
(c) determines that drug records are in order and that an account of all controlled substances is maintained and
reconciled monthly_
(3) The drug regimen of each resident must be reviewed at least once a month by a licensed pharmacist
(a) The pharmacist must report any irregularities to the attending physician and the director of nursing or health
services supervisor
(b) The physician and the director of Nursing or health services supervisor must indicate acceptance or rejection of
the report and document any action taken
(4) Pharmacy personnel must ensure that labels on drugs and biologicals are in accordance with currently accepted professional principles and include the appropriate accessory and cautionary instructions and the expiration date
(5) The facility must store all drugs and biologicals in locked compartments under proper temperature controls according to R432- I 50- I 9 (6)e) and permit only authorized personnel to have access to the keys
Page 3 of 5
Emergency Kit Compliance Overview Provided to DOPL on 2122014 by Jared Memmott
(a) The facility must provide separately locked permanently affixed compartments for storage of controlled substances listed in Schedule II of the Comprehensive Drug Abuse Prevention and Control Act of 1976 and other drugs subject to abuse except when the facility uses single unit dose package drug distribution systems in which the
quantity stored is minimal and a missing dose can be readily detected
(b) Non-medication materials that are poisonous or caustic may not be stored with medications
(c) Containers must be clearly labeled
(d) Medication intended for internal use shall be stored separately from medication intended for external use
(e) Medications stored at room temperature shall be maintained within 59 and 80 degrees F
() Refrigerated medications shall be maintained within 36 and 46 degrees F
(6) The facility must maintain an emergency drug supply
(a) Emergency drug containers shall be sealed to prevent unauthorized use
(b) Contents of the emergency drug supply must be listed on the outside of the container and the use of contents shall be documented by the nursing staff
(c) The emergency drug supply shall be stored and located for access by the nursing staff
(d) The pharmacist must inventory the emergency drug supply monthly
(e) Used or outdated items shall be replaced within 72 hours by the pharmacist
(7) The pharmacy must dispense and the facility must ensure that necessary drugs and biologicals are
provided on a timely basis
(8) The facility must limit the duration of a drug order in the absence of tbe prescribers specific
instructions
(9) Drug references must be available for all drugs used in the facility References shall include generic and brand
names available strength and dosage forms indications and side effects and other pharmacological data
(10) Drugs may be sent with the resident upon discharge if so ordered by the discharging physician provided
tbat
(a) such drugs are released in compliance R156-17a-619 and
(b) a record of the drugs sent with the resident is documented in the residents health record
(II) Disposal of controlled substances must be in accordance with the Pharmacy Practice Act
Page 4 of 5
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Emergency Kit Compliance Overview Provided to DOPL on 2122014 by Jared Memmott
IMPORTANT POINTS
~ The practice of pharmacy definition and the above described statute prohibit anyone other than a properly licensed pharmacy from possessing stock controlled substances or legend drugs
~The Utah Department of Health has invalid and antiquated administrative rules that supersedes what statute does not allow and existing pharmacy law and rule does not even address some of the operating standards mandated by the pharmacist and pharmacy who are providing pharmacy services
~As the Federal Register states that emergency kits in Long Term Care Facilities are only viewed as compliant with the Controlled Substance Act IF the appropriate state agency or regulatory authority specifically approves such placement anltLQ()lgates procedures which delineate The Utah Department of Health is not the appropriate state agency and moreover the appropriate Utah statute conflicts with the inappropriate state agency administrative rules
~ Additionally the existing administrative rules do not define and cover everything mandated in the Federal Register to even be considered compliant
Page 5 of 6
State of Utah Department of Comnlerce Division of Occupational and Professional Licensing
GARY R HERBERT FRANCINEA GIANI MARK B STEINAGEL GOlernnr Executive Director DiviSIOn Director
GUIDELINES FOR HOSPITAL PHARMACIES and EMERGENCY DEPARTMENT TREATMENT
Approved by the Board of Pharmacy May 21 2012
The pharmacist is responsible for all pharmacy practice as del ineated under Utah Code 58-17b and 58-37fto include
bull ordering receiving and stocking bull filling drug carts drug rooms emergency drug stocks bull controlling inventory including audit trail [or each controlled substance bull maintaining and adhering to policies and protocols that maintain controls over controlled
substances (Utah Controlled Substances Act Subsection R156-37-502 defines unprofessional conduct to include (4) failing to maintain controls over controlled substances which would be considered by a prudent practitioner to be effective against diversion theft or shortage of controlled substances (5) being unable to account for shortages of controlled substances for any controlled substance inventory for which the licensee has responsibility)
bull reviewing Medication Proof of Use forms or logs returned to the pharmacist for purposes of review and reconciliation and
bull submitting all required controlled substance prescription information to the Controlled Substance Database pursuant to Utah Code 58-37f-203
NOTE Responsible means accountable for The pharmacist may delegate the task yet is ultimately accountable for the outcome Final checks of medications or medication profiles cannot be delegated
After-hours Medications Taken from Pharmacy When a Pharmacy is Closed
Only a pharmacist nurse supervisor or charge nurse can enter the pharmacy when the bull pharmacy is closed Medications can only be taken from the pharmacy on an emergency as needed basis Abull medication log must be used to keep a per medication inventory Only a pharmacist nurse supervisor or charge nurse can have access and the alarm code bull to whel1_~ltj)armacL~19~~~alth0lglil~one~~tthe p(irmacist can _~~___ ~ have a key to the locked controlled substance inventory in the pharmacy The pharmacy must still be equipped with a security system to permit detection of entry at all times when the facility is closed An adequate security system for inpatient phannacies within hospitals would be a system similar to a badge reader access which could uniquely store and retain which authorized person had made entry into the pharmacy after regular hours
wwwdoplulahgoYmiddot Heber M Wells Buildingmiddot 160 East300 South PO Box 146741 Salt Lake City UT 84114-6741 telephone (801) 530-6628 bull tollmiddot free in Utah (866) 275-3675 bull fax (801) 530-651 1 bull investigations fax (801) 530middot630 I UTAH
Dispensing of Drugs from an Emergency Room
bull Emergency room staff including the prescribing practitioner or Iicensed nurse cannot dispense prescriptions to a patient The prescribing practitioner can give an emergency supply which is properly labeled to a patient to get a patient started on the medication until a pharmacy is open This is not to be construed to allow a prescribing practitioner to give out an entire prescription amount
The related community standard for the treatment of typical Emergency Department conditions and STI prophylaxis is seven days
bull Such emergency doses of medications shall be labelcd with at least -Prescribing practitioners name and facility name and telephone number -Patients name -Name ormedication and strength -Number oftablets given -Date given and -I nstrLlctions for use
bull Records of controlled substances dispensed by the prescribing practitioner must be provided to the pharmacy so that applicable prescription data can be reported to the CSD
NOTE Physicians may give out samples which are clearly marked as a sample not for resale unti I the patient can get to a pharmacy or to try the medication for possible untoward effects Samples must be dispensed pursuant to Utah Code Annotated sect 58shy17b-610
Repackaging bull It is illegal for retail phannacies to repackage medications for resale to hospitals clinics
or other pharmacies The hospital pharmacy could legally repackage medications for use in its own institution
Federal Statute
According to Federal regulations repackaging requires a manufacturers license as stated in US Code 21-130001(27) and USC 21-1301lI(a)
USC 21-130001 reads Manufacture means the producing preparation propagation compounding or processing of a drug or other substance or the packaging or repackaging of such substance or the labeling or relabeling of the commercial container of such substance but
~----- middotmiddotmiddotmiddot_~aoesmmiddotnot IncluOelne-aCliiities omiddotf-a-praclilioifef-wlio~middotasan1nci(rentwhlS1hmiddoteraoffilnistratle)ffT5f-
dispensing such substance in the course of hisher professional practice prepares compounds packages or labels such substance
USC 21-130111 (a) reads Every person who manufactures distributes dispenses imports or exports any controlled substances or who proposes to engage in the manufacture distribution dispensing importation or exportation of any controlled substances shall obtain a registration
wwwdoptutahgovmiddot Heber M Wells Buildingmiddot 160 East 300 Southmiddot PO Box 146741 Salt Lake City UT 84114-6741 telephone (801) 530-6628middot toll-free in Utah (866) 275-3675 fax (801) 530-6511 investigations fax (801) 530-6301
LEGISLA TIVE GENERAL COUNSEL SB178 ct Approved for Filing Sc Allred ct
ct 02-05-14 1 56 PM ct
1 CONTROLLED SUBSTANCE DATABASE MODIFICATIONS
2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Evan J Vickers
5 House Sponsor Bradley G Last
6
7 LONG TITLE
8 General Description
9 This bill modifies the Controlled Substance Database Act regarding access by pharmacy
10 technicians
11 Highlighted Provisions
12 This bill
13 ~ allows the phannacist-in-charge to designate a licensed phannacy technician to have
14 access to the database on behalf of the phannacist in accordance with statutory
15 requirements
16 Money Appropriated in this Bill
17 None
18 Other Special Clauses
19 None
20 Utah Code Sections Affected
21 AMENDS
22 58-37fmiddot301 as last amended by Laws of Utah 2013 Chapters 12 130 and 262
23
24 Be it enacted by the Legislature ofthe state ofUtah
25
26
27
Section 1 Section 58-37fmiddot301 is amended to read
58-37fmiddot301 Access to database
(1) The division shall make rules in accordance with Title 63G Chapter 3 Utah
rJlbull =bull
1111111111111111111111111111111111111111
02-05-14 156 PM SB178
59 (A) fit within the responsibilities of the Department of Health for health and welfare
60 (B) are reviewed and approved by an Institutional Review Board that is approved for
61 human subject research by the United States Department of Health and Human Services and
62 (C) are not conducted for profit or commercial gain and
63 (D) are conducted in a research facility as defined by division rule that is associated
64 with a university or college in the state accredited by the Northwest Commission on Colleges
65 and Universities
66 (iii) the designee protects the information as a business associate of the Department of
67 Health and
68 (iv) the identity of the prescribers patients and pharmacies in the database are
69 de-identified confidential not disclosed in any manner to the designee or to any individual
70 who is not directly involved in the scientific studies
71 (e) a licensed practitioner having authority to prescribe controlled substances to the
72 extent the information
73 (i) (A) relates specifically to a current or prospective patient of the practitioner and
74 (B) is provided to or sought by the practitioner for the purpose of
75 (I) prescribing or considering prescribing any controlled substance to the current or
76 prospective patient
77 (II) diagnosing the current or prospective patient
78 (nn providing medical treatment or medical advice to the current or prospective
79 patient or
80 (IV) determining whether the current or prospective patient
81 (Aa) is attempting to fraudulently obtain a controlled substance from the practitioner
82 or
83 (Bb) has fraudulently obtained or attempted to fraudulently obtain a controlled
84 substance from the practitioner
85 (ii) (A) relates specifically to a fonner patient of the practitioner and
86 (B) is provided to or sought by the practitioner for the purpose of determining whether
87 the former patient has fraudulently obtained or has attempted to fraudulently obtain a
88 controlled substance from the practitioner
89 (iii) relates specifically to an individual who has access to the practitioners Drug
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02-05-14 156 PM SB178
121 58-3 7f-203(3 )(b) with respect to the employee
122 (h) a licensed pharmacist having authority to dispense a controlled substance to the
123 extent the information is provided or sought for the purpose of
124 (i) dispensing or considering dispensing any controlled substance or
125 (ii) determining whether a person
126 (A) is attempting to fraudulently obtain a controlled substance from the pharmacist or
127 (B) has fraudulently obtained or attempted to fraudulently obtain a controlled
128 substance from the pharmacist
129 (i) in accordance with Subsection (3)(a) a licensed pharmacy technician who is an
]30 employee of a pharmacy as defined in Section 58-17b-l 02 for the purposes described in
131 Subsection (2)(h)(i) or (iO if
132 0) the employee is designated by the pharmacist-in-charge as an individual authorized
133 to access the information on behalf of a licensed pharmacist employed by the pharmacy
134 (ii) the pharmacist-in-charge provides written notice to the division of the identity of
135 the employee and
136 (iii) the division
137 CA) grants the employee access to the database and
138 (B) provides the employee with a password that is unique to that employee to access
139 the database in order to permit the division to comply with the requirements of Subsection
140 58-37f-203(3)(b) with respect to the employee
141 [fiJ] ill federal state and local law enforcement authorities and state and local
142 prosecutors engaged as a specified duty of their employment in enforcing laws
143 (i) regulating controlled substances
144 (ii) investigating insurance fraud Medicaid fraud or Medicare fraud or
145 (iii) providing information about a criminal defendant to defense counsel upon request
146 during the discovery process for the purpose of establishing a defense in a criminal case
147 [61] fhl employees ofthe Office oflntemal Audit and Program Integrity within the
148 Department of Health who are engaged in their specified duty of ensuring Medicaid program
149 integrity under Section 26-18-23
150 [fki] ill a mental health therapist if
151 (i) the information relates to a patient who is
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02-05-14 156 PM SB178
183 designated under Subsection (2)(f) (2)(g) or (4)(c) should be granted access to the database
184 and
185 (ii) establish the information to be provided by an emergency room employee under
186 Subsection (4)
187 (c) The division shall grant an employee designated under Subsection (2)(f) (2)(g) or
188 (4)( c) access to the database unless the division determines based on a background check that
189 the employee poses a security risk to the information contained in the database
190 (4) (a) An individual who is employed in the emergency room ofa hospital may
191 exercise access to the database under this Subsection (4) on behalf of a licensed practitioner if
192 the individual is designated under Subsection (4)( c) and the licensed practitioner
193 (i) is employed in the emergency room
194 Oi) is treating an emergency room patient for an emergency medical condition and
195 (iii) requests that an individual employed in the emergency room and designated under
196 Subsection (4)( c) obtain information regarding the patient from the database as needed in the
197 course of treatment
198 (b) The emergency room employee obtaining information from the database shall
199 when gaining access to the database provide to the database the name and any additional
200 identifiers regarding the requesting practitioner as required by division administrative rule
201 established under Subsection (3)(b)
202 (c) An individual employed in the emergency room under this Subsection (4) may
203 obtain information from the database as provided in Subsection (4)(a) if
204 (i) the employee is designated by the practitioner as an individual authorized to access
205 the information on behalf of the practitioner
206 (ii) the practitioner and the hospital operating the emergency room provide written
207 notice to the division of the identity of the designated employee and
208 (iii) the division
209 (A) grants the employee access to the database and
210 (B) provides the employee with a password that is unique to that employee to access
211 the database in order to permit the division to comply with the requirements of Subsection
212 58-37f-203(3)(b) with respect to the employee
213 (d) The division may impose a fee in accordance with Section 63J-I-504 on a
- 7
LEGISLATIVE GENERAL C01JNSEL SB55 iL Approved for Filing Cl Dupont iL lst Sub (Green)
iL 02-07-14 416 PM iL
Senator Evan J Vickers proposes the following substitute bill
PHARMACEUTICAL DISPENSING AMENDMENTS
2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Evan J Vickers
5 House Sponsor Stewart Barlow
6
7 LONG TITLE
8 General Description
9 This bill amends the Pharmacy Practice Act to create a dispensing medical practitioner
10 license and a license classification for a dispensing medical practitioner clinic
11 pharmacy
12 Highlighted Provisions
13 This bill
14 defines terms
15 establishes the license classification dispensing medical practitioner under the
16 Pharmacy Practice Act for medical practitioners who prescribe and dispense a drug
17 establishes the pharmacy facility license classification dispensing medical
18 practitioner clinic pharmacy under the Pharmacy Practice Act
19 creates Part 8 Dispensing Medical Practitioner and Dispensing Medical Practitioner
20 Clinic Pharmacy
21 removes the exemption from the Pharmacy Practice Act for medical practitioners
22 who prescribe and dispense a cosmetic drug injectable weight loss drug or a cancer
23 drug treatment regimen
24 requires a license as a dispensing medical practitioner for a health care practitioner 00
25 to dispense bull bull=
1111111111111111111111111111111111111111111111111111111
02-07-14 416 PM 1st Sub (Green) SB 55
615 Practitioner Clinic Pharmacy II
616 Section 8 Section 58-17b-802 is enacted to read
617 58-17b-802 Definitions
618 As used in this part
619 (1) (a) Cosmetic drug means a prescription drug that
620 (i) is for the purpose of promoting attractiveness or altering the appearance of an
621 individual and
622 (ii) (A) is listed as a cosmetic drug subject to the exemption under this section by the
623 division by administrative rule or
624 CB) has been expressly approved for online dispensing whether or not it is dispensed
625 online or through a physicians office
626 (b) Cosmetic drug does not include a prescription drug that is
627 (i) a controlled substance
628 (ii) compounded by the physician or
629 (iii) prescribed or used for the patient for the purpose of diagnosing curing or
630 preventing a disease
631 (2) Employer sponsored clinic means an entity that S-t has a medical director who is
631 a licensed as a physician as defined in Section 58-67-102 and S offers health care only to the
632 employees of an exclusive group of employers and the employees dependents
633 (3) Health care is as defined in Section 31A-1-301
634 (4) Ca) Injectable weight loss drug means an injectable prescription drug
635 (n prescribed to promote weight loss and
636 (ii) listed as an injectable prescription drug subject to exemption under this section by
637 the division by administrative rule
638 (b) Injectable weight loss drug does not include a prescription drug that is a
639 controlled substance
640 (5) Prepackaged drug means a prescription drug that
641 (a) is not listed under federal or state law as a Schedule I II ill IV or V drug and
642 (b) is packaged in a fixed quantity per package by
643 (i) the drug manufacturer
644 (ii) a pharmaceutical wholesaler or distributor or
645 (iii) a pharmacy licensed under this title
- 21 Senate Committee Amendments 2-13-2014 Jplcjd
1st Sub (Green) SB 55 02-07-14 416 PM
646 Section 9 Section 58-17b-803 is enacted to read
647 58-17b-803 Qualifications for licensure as a dispensing medical practitioner -shy
648 Scope of practice
649 (1) An applicant for a license as a dispensing medical practitioner shall
650 (a) be licensed in good standing under at least one of the chapters listed in Subsection
651 58-17b-l02(23)(a) and
652 (b) submit an application for a license as a dispensing medical practitioner in a form
653 prescribed by the division and pay a fee established by the S [depal tment] divisionS ~
654 (2) The division shall accept the licensing in good standing under Subsection (1) in lieu
655 of requiring an applicant for a license under this part to comply with Sections 58-17b-303 and
656
657 (3) A dispensing medical practitioner may dispense in accordance with this part
658 (a) a cosmetic drug and an injectable weight loss drug if
659 (i) the drug was prescribed by the dispensing medical practitioner to the dispensing
660 medical practitioners patient and
661 Oi) the dispensing medical practitioner complies with administrative rules adopted by
662 the division under Subsection 58-17-802(1)
663 (b) a cancer drug treatment regimen if the dispensing medical practitioner complies
664 with Section 58-17b-805 and
665 (c) a pre-packaged drug to an employee or a dependent of an employee at an employer
666 sponsored clinic if the dispensing medical practitioner
667 (i) treats an employee or the dependent of an employee of one of an exclusive group
668 of employers at an employer sponsored clinic
669 (ii) prescribes a prepackaged drug to the employee or the employees dependent
670 (iii) dispenses the prepackaged drug at the employer sponsored clinic and
671 (iv) complies with administrative rules adopted by the division in consultation with the
672 Board of Pharmacy that establish labeling record keeping patient counseling purchasing and
673 distribution operating treatment quality of care and storage requirements
674 (4) A dispensing medical practitioner
675 Ca) shall inform the patient
676 (i) that the drug dispensed by the practitioner may be obtained from a pharmacy
- 22 - Senate Committee Amendments 2-13-2014 picjd
02-07-14 416 PM 1st Sub (Green) SB 55
739 58-17b-806 Dispensing medical practitioner -- Dispensing medical practitioner
740 clinic pharmacy -- Unprofessional and Unlawful conduct
741 ill S Ull S The division S [ iii consultation witb tile boal d shall
742 (a) I epol t a violation of this chapter b a dispensing medical pi actitiollel to] shall consult
742a with S the
743 dispensing medical practitioners appropriate licensing board as designated in Subsection
744 5S-17b-l02(23)(a) S reeardine a violation oftMs chapterS and
745 (hl S the Pharmacy Board shall if requested by the licensine board of the dispensine
745a medical practitionerS assist the licensing board for the dispensing medical practitioner with
745b reviewing the
746 violations of the provisions of this chapter
747 (2) The division S [ in collabOi atioll with the Boal d ofPhall1l3C]S may take
747a appropriate
748 action against a dispensing medical practitioner in accordance with this chapter if the
749 licensing board designated in Subsection 58-17b- 02(23)(a) recommends to the division that
750 action be taken under this chapter
751 (3) The division in consultation with the board is the primary enforcer under this
752 chapter for a dispensing medical practitioner clinic pharmacy licensed under Section
753 58-17b-804
754 Section 13 Section 58-31b-502 is amended to read
755 58-31b-502 Unprofessional conduct
756 Unprofessional conduct includes
757 (l) failure to safeguard a patients right to privacy as to the patients person condition
758 diagnosis personal effects or any other matter about which the licensee is privileged to know
759 because of the licensees or person with a certifications position or practice as a nurse or
760 practice as a medication aide certified
761 (2) failure to provide nursing service or service as a medication aide certified in a
762 manner that demonstrates respect for the patients human dignity and unique personal character
763 and needs without regard to the patients race religion ethnic background socioeconomic
764 status age sex or the nature of the patients health problem
765 (3) engaging in sexual relations with a patient during any
766 (a) period when a generally recognized professional relationship exists between the
767 person licensed or certified under this chapter and patient or
768 (b) extended period when a patient has reasonable cause to believe a professional
769 relationship exists between the person licensed or certified under the provisions of this chapter
- 25 - Senate Committee Amendments 2-13-2014Iplcjd
LEGISLA TIVE GENERAL COUNSEL SB138 ct Approved for Filing Sc Allred ct
ct 02-04-14 1220 PM ct
1 CONTROLLED SUBSTANCES ACT AMENDMENTS
2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Evan J Vickers
5 House Sponsor Stewart Barlow
6
7 LONG TITLE
8 General Description
9 This bill modifies the Utah Controlled Substances Act regarding prescriptions for
10 controlled substances
11 Highlighted Provisions
12 This bill
13 ~ provides that more than one controlled substance may be included in a prescription
14 Money Appropriated in this Bill
15 None
16 Other Special Clauses
17 None
18 Utah Code Sections Affected
19 AMENDS
20 58-37-6 as last amended by Laws of Utah 2012 Chapter 272
21
22 Be it enacted by the Legislature of the state ofUtah
23 Section 1 Section 58-37-6 is amended to read
24 58-37-6 License to manufacture produce distribute dispense administer or
25 conduct research -- Issuance by division -- Denial suspension or revocation -- Records
26
27
required -- Prescriptions
(1) (a) The division may adopt rules relating to the licensing and control of the bull
1111111111111111111111111111111111111111
SB138 02-04-14 1220 PM
214 (ii) the prescribed controlled substance is to be used in research
215 (f) Except when administered directly to an ultimate user by a licensed practitioner
216 controlled substances are subject to the following restrictions
217 (i) (A) A prescription for a Schedule IT substance may not be refilled
218 (B) A Schedule II controlled substance may not be filled in a quantity to exceed a
219 one-months supply as directed on the daily dosage rate of the prescriptions
220 (ii) A Schedule ill or IV controlled substance may be filled only within six months of
221 issuance and may not be refilled more than six months after the date of its original issuance or
222 be refilled more than five times after the date of the prescription unless renewed by the
223 practitioner
224 (iii) All other controlled substances in Schedule V may be refilled as the prescribers
225 prescription directs but they may not be refilled one year after the date the prescription was
226 issued unless renewed by the practitioner
227 (iv) Any prescription for a Schedule IT substance may not be dispensed if it is not
228 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days
229 after the date the prescription was issued or 30 days after the dispensing date if that date is
230 specified separately from the date of issue
231 (v) A practitioner may issue more than one prescription at the same time for the same
232 Schedule IT controlled substance but only under the following conditions
233 (A) no more than three prescriptions for the same Schedule IT controlled substance may
234 be issued at the same time
235 (B) no one prescription may exceed a 30-day supply
236 (C) a second or third prescription shall include the date of issuance and the date for
237 dispensing and
238 (D) unless the practitioner determines there is a valid medical reason to the contrary
239 the date for dispensing a second or third prescription may not be fewer than 30 days from the
240 dispensing date of the previous prescription
241 [(1i) Each prescription rot a controlled snbstance may eontain only one controlled
242 substance per pIescription frlim and may not contain any other legend dmg 01 prescription
243 item]
244 (g) An order for a controlled substance in Schedules IT through V for use by an
- 8 shy
LEGISLATIVE GENERAL COUNSEL it Approved for Filing CJ Dupont it
HB114
it 02-06-14855 AM it
1 MAIL-ORDER WHOLESALE DRUG AMENDMENTS 2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Stewart Barlow
5 Senate Sponsor ______
6
7 LONG TITLE
8 General Description
9 This bill amends the Pharmacy Practice Act
10 Highlighted Provisions
11 This bill
12 ~ amends the definition of a class C pharmacy subject to regulation under the
13 Pharmacy Practice Act
14 Money Appropriated in this Bill
15 None
16 Other Special Clauses
17 This bi II takes effect on July 1 2014
18 Utah Code Sections Affected
19 AMENDS
20 58-17b-102 as last amended by Laws of Utah 2013 Chapters 52 166 and 423
21
22 Be it enacted by the Legislature ofthe state ofUtah
23 Section 1 Section 58-17b-102 is amended to read
24 58-17b-102 Definitions
25 In addition to the definitions in Section 58-1-102 as used in this chapter
26
27
(1) Administering means
(a) the direct application of a prescription drug or device whether by injection
==bull =bull
1111111111111111111111111111111111111111
02-06-14855 AM HB114
59 (9) Centralized prescription processing means the processing by a pharmacy of a
60 request from another pharmacy to fill or refill a prescription drug order or to perform
61 processing functions such as dispensing drug utilization review claims adjudication refill
62 authorizations and therapeutic interventions
63 (10) Class A pharmacy means a pharmacy located in Utah that is authorized as a
64 retail pharmacy to compound or dispense a drug or dispense a device to the public under a
65 prescription order
66 (11) Class B pharmacy
67 (a) means a pharmacy located in Utah
68 (i) that is authorized to provide pharmaceutical care for patients in an institutional
69 setting and
70 (ii) whose primary purpose is to provide a physical environment for patients to obtain
71 health care services and
72 (b) (i) includes closed-door hospital clinic nuclear and branch pharmacies and
73 (ii) pharmaceutical administration and sterile product preparation facilities
74 (12) Class C pharmacy means a pharmacy [located ill Utah that is anthOl ized to
75 engage] that engages in the manufacture production wholesale or distribution of drugs or
76 devices in Utah
77 (13) Class D pharmacy means a nonresident pharmacy
78 (14) Class E pharmacy means all other pharmacies
79 (15) Closed-door pharmacy means a pharmacy that provides pharmaceutical care to a
80 defined and exclusive group of patients who have access to the services of the pharmacy
81 because they are treated by or have an affiliation with a specific entity including a health
82 maintenance organization or an infusion company but not including a hospital pharmacy a
83 retailer of goods to the general public or the office of a practitioner
84 (16) Collaborative pharmacy practice means a practice of pharmacy whereby one or
85 more pharmacists have jointly agreed on a voluntary basis to work in conjunction with one or
86 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical
87 care functions authorized by the practitioner or practitioners under certain specified conditions
88 or limitations
89 (17) Collaborative pharmacy practice agreement means a written and signed
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02-06-14855 AM HB114
369 and
370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in
371 collaboration with the board
372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501
373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and
374 may be further defined by rule
375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that
376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration
377 for animals
378 Section 2 Effective date
379 This bill takes effect on July I 2014
Legislative Review Note as of 2-4-14 1243 PM
Office of Legislative Research and General Counsel
- 13 shy
LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t
t 02-05-14 122PM t
1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG
2 AMENDMENTS
3 2014 GENERAL SESSION
4 STATE OF UTAH
5 Chief Sponsor Stewart Barlow
6 Senate Sponsor
7
8 LONG TITLE
9 General Description
10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from
11 its licensing requirements under certain circumstances
12 Highlighted Provisions
13 This bill
14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy
15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an
16 employer sponsored clinic and complies with other requirements
17 repeals subject to sunset review the provisions of this bill relating to the exemption
18 described above and
19 ~ makes technical and conforming changes
20 Money Appropriated in this Bill
21 None
22 Other Special Clauses
23 None
24 Utah Code Sections Affected
25 AMENDS
26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~
27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull
1111111111111111111111111111111111111111
HBI06 02-05-14 122 PM
28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278
29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234
30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351
31 ENACTS
32 58-17b-3097 Utah Code Annotated 1953
33
34 Be it enacted by the Legislature ofthe state ofUtah
35 Section 1 Section 58-17b-301 is amended to read
36 58-17b-301 License required -- License classifications for individuals
37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the
38 practice of a pharmacy technician except as specifically provided in Section 58-1-307
39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097
40 (2) The division shall issue to an individual who qualifies under this chapter a license
41 in the classification of
42 (a) pharmacist
43 (b) pharmacy intern or
44 (c) pharmacy technician
45 Section 2 Section 58-17b-302 is amended to read
46 58-17b-302 License required -- License classifications for pharmacy facilities
47 (l) A license is required to act as a pharmacy except as specifically exempted from
48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or
49
50 (2) The division shall issue a pharmacy license to a facility that qualifies under this
51 chapter in the classification of a
52 (a) class A pharmacy
53 (b) class B pharmacy
54 (c) class C pharmacy
55 (d) class D pharmacy or
56 (e) class E pharmacy
57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist
58 at the same address a separate license shall be required for each pharmacy
-2shy
02-05-14 122 PM HBI06
59 (4) The division may further define or supplement the classifications of pharmacies
60 The division may impose restrictions upon classifications to protect the public health safety
61 and welfare
62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by
63 rule
64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy
65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities
66 of the pharmacy regardless of the form of the business organization
67 Section 3 Section 58-17b-309 is amended to read
68 58-17b-309 Exemptions from licensure
69 (l) [For ptnp05C5 of] As used in this section
70 (a) Cosmetic drug
71 (i) means a prescription drug that is
72 (A) for the purpose of promoting attractiveness or altering the appearance of an
73 individual and
74 (8) listed as a cosmetic drug subject to the exemption under this section by the division
75 by administrative rule or has been expressly approved for online dispensing whether or not it is
76 dispensed online or through a physicians office and
77 (ii) does not include a prescription drug that is
78 (A) a controlled substance
79 (8) compounded by the physician or
80 (C) prescribed or used for the patient for the purpose of diagnosing curing or
81 preventing a disease
82 (b) Injectable weight loss drug
83 (i) means an injectable prescription drug
84 (A) prescribed to promote weight loss and
85 (8) listed as an injectable prescription drug subject to exemption under this section by
86 the division by administrative rule and
87 (ii) does not include a prescription drug that is a controlled substance
88 (c) Prescribing practitioner means an individual licensed under
89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with
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HB106 02-05-14 122 PM
90 prescriptive practice
91 (ii) Chapter 67 Utah Medical Practice Act
92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or
93 (iv) Chapter 70a Physician Assistant Act
94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l
95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the
96 acts or practices described in this section without being licensed under this chapter
97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the
98 individual notifies the division in writing of the individuals intent to dispense a drug under this
99 [snbsectioll] Subsection (2)
100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1
101 (c) an individual engaging in the practice of pharmacy technician under the direct
102 personal supervision of a pharmacist while making satisfactory progress in an approved
103 program as defined in division rule
104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an
105 injectable weight loss drug to the prescribing practitioners patient in accordance with
106 Subsection (4) or
107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists
108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic
109 drug to the optometrists patient in accordance with Subsection (4)
110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under
111 Subsection (2)( c) must take all examinations as required by division rule following completion
112 of an approved curriculum of education within the required time frame This exemption
113 expires immediately upon notification of a failing score of an examination and the individual
114 may not continue working as a pharmacy technician even under direct supervision
115 (4) A prescribing practitioner or optometrist is exempt from licensing under the
116 provisions of this part if the prescribing practitioner or optometrist
117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the
118 authority to dispense under Subsection (4)(b) and
119 (ii) informs the patient
120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing
-4shy
HB106 02-05-14 122 PM
152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the
153 prescribing practitioners or optometrists office and determine if the provisions of this section
154 are being met by the prescribing practitioner or optometrist
155 (d) If a prescribing practitioner or optometrist violates a provision of this section the
156 prescribing practitioner or optometrist may be subject to discipline under
157 (i) this chapter and
158 (ii) (A) Chapter 16a Utah Optometry Practice Act
159 (B) Chapter 31 b Nurse Practice Act
160 (C) Chapter 67 Utah Medical Practice Act
161 (D) Chapter 68 Utah Osteopathic Medical Practice Act
162 (E) Chapter 70a Physician Assistant Act or
163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act
164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the
165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah
166 Optometry Practice Act
167 Section 4 Section 58-17b-3095 is amended to read
168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy
169 Division study of dispensing practitioners
170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen
171 (a) means a prescription drug used to treat cancer manage its symptoms or provide
172 continuity of care for a cancer patient
173 (b) includes
174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal
175 methods and
176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize
177 physical and psychological symptoms or pain or to improve patient tolerance of cancer
178 treatments or prepare a patient for a subsequent course of therapy and
179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug
180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections
181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt
182 from licensure under this chapter
- 6shy
HB106 02-05-14 122 PM
214 (ii) is acting under the direction of a prescribing practitioner who is immediately
215 available on site for any necessary consultation and who has complied with Subsection
216 (2)(b)(i)
217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the
218 outpatient clinic setting and
219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)
220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to
221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section
222 (b) The evaluation under this Subsection (3) shall include
223 (i) practitioner compliance with the requirements of this section and Section
224 58-l7b-309
225 (ii) current research on dispensing and patient safety
226 (iii) survey of other state dispensing laws and
227 (iv) recommendations for future action concerning practitioner dispensing
228 (c) The division shall report to the Legislatures Health and Human Services Interim
229 Committee by November 302012 and by November 302013 with the results and
230 recommendations from the evaluation required by this Subsection (3)
231 (4) This section sunsets in accordance with Section 631-1-258
232 Section 5 Section 58-17b-3097 is enacted to read
233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an
234 employer sponsored clinic
235 (1) As used in this section
236 (a) Employer sponsored clinic means an entity that offers health care only to the
237 employees of an exclusive group of employers and the employees dependents
238 (b) Health care is as defined in Section 31 A-J-301
239 (c) Prepackaged drug means a prescription drug that
240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and
241 (ii) is packaged in a fixed quantity per package by
242 (A) the drug manufacturer
243 (B) a pharmaceutical wholesaler or distributor or
244 (C) a pharmacy licensed under this title
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~ -- -------------------
02-05-14 122 PM HB106
245 Cd) Prescribing practitioner is as defined in Section 58-17b-309
246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309
247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing
248 requirements of this chapter if the prescribing practitioner
249 Ca) treats an employee of one of an exclusive group of employers at an employer
250 sponsored clinic
251 Cb) prescribes a prepackaged drug to the employee
252 Cc) dispenses the prepackaged drug at the employer sponsored clinic
253 (d) notifies the division
254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the
255 employer sponsored clinic and
256 (ii) of the drug the prescribing practitioner intends to dispense
257 Ce) determines that providing the prepackaged drug to the employee at the employer
258 sponsored clinic is in the employees best interest
259 (f) informs the employee
260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner
261 from a pharmacy that is unaffiliated with the prescribing practitioner
262 (ii) of the directions for appropriate use of the prepackaged drug
263 (iii) of potential side effects to the use of the prepackaged drug and
264 (iv) how to contact the prescribing practitioner if the employee has questions or
265 concerns regarding the drug
266 (g) offers the employee the opportunity to consult with a pharmacist if the employee
267 asks for patient counseling and
268 (h) follows the administrative rules for a prescribing practitioner at an employer
269 sponsored clinic established by the division under Subsection (4)
270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a
271 prepackaged drug under this section requires physician supervision in its scope ofpractice
272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the
273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter
274 68 Utah Osteopathic Medical Practice Act
275 (4) The division shall in consultation with the board of pharmacy and the Physicians
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HBI06 02-05-14 122 PM
276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title
277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping
278 patient counseling purchasing and distribution operating treatment quality of care and
279 storage requirements for a prescribing practitioner at an employer sponsored clinic
280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a
281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing
282 practitioner is in compliance with this section
283 (6) If a prescribing practitioner violates a provision of this section the prescribing
284 practitioner may be subject to discipline under
285 (a) this chapter and
286 (b) any other chapter that governs the terms of the prescribing practitioners license
287 (7) The division shall evaluate the exemption created by this section and report to the
288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1
289 2018 on the results of the evaluation and the divisions recommendations regarding the
290 exemption
291 Section 6 Section 631-1-258 is amended to read
292 631-1-258 Repeal dates Title 58
293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is
294 repealed July 12016
295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015
296 (3) Section 58-17b-3095 is repealed July 1 2015
297 (4) Section 58-17b-3097 is repealed on July 12018
298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1
299 2018
300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1
301 2023
302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing
303 Act is repealed July 1 2019
304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1
305 2015
306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is
- 10shy
02-05-14 1 22 PM HB106
307 repealed July 12023
308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1
309 2014
310 [ttej] ill) Section 58-69-3025 is repealed on July 12015
311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017
Legislative Review Note as of 2-3-14 418 PM
Office of Legislative Research and General Counsel
- 11 shy
Emergency Kit Compliance Overview Provided to DOPL on 2122014 by Jared Memmott
(a) The facility must provide separately locked permanently affixed compartments for storage of controlled substances listed in Schedule II of the Comprehensive Drug Abuse Prevention and Control Act of 1976 and other drugs subject to abuse except when the facility uses single unit dose package drug distribution systems in which the
quantity stored is minimal and a missing dose can be readily detected
(b) Non-medication materials that are poisonous or caustic may not be stored with medications
(c) Containers must be clearly labeled
(d) Medication intended for internal use shall be stored separately from medication intended for external use
(e) Medications stored at room temperature shall be maintained within 59 and 80 degrees F
() Refrigerated medications shall be maintained within 36 and 46 degrees F
(6) The facility must maintain an emergency drug supply
(a) Emergency drug containers shall be sealed to prevent unauthorized use
(b) Contents of the emergency drug supply must be listed on the outside of the container and the use of contents shall be documented by the nursing staff
(c) The emergency drug supply shall be stored and located for access by the nursing staff
(d) The pharmacist must inventory the emergency drug supply monthly
(e) Used or outdated items shall be replaced within 72 hours by the pharmacist
(7) The pharmacy must dispense and the facility must ensure that necessary drugs and biologicals are
provided on a timely basis
(8) The facility must limit the duration of a drug order in the absence of tbe prescribers specific
instructions
(9) Drug references must be available for all drugs used in the facility References shall include generic and brand
names available strength and dosage forms indications and side effects and other pharmacological data
(10) Drugs may be sent with the resident upon discharge if so ordered by the discharging physician provided
tbat
(a) such drugs are released in compliance R156-17a-619 and
(b) a record of the drugs sent with the resident is documented in the residents health record
(II) Disposal of controlled substances must be in accordance with the Pharmacy Practice Act
Page 4 of 5
bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull
Emergency Kit Compliance Overview Provided to DOPL on 2122014 by Jared Memmott
IMPORTANT POINTS
~ The practice of pharmacy definition and the above described statute prohibit anyone other than a properly licensed pharmacy from possessing stock controlled substances or legend drugs
~The Utah Department of Health has invalid and antiquated administrative rules that supersedes what statute does not allow and existing pharmacy law and rule does not even address some of the operating standards mandated by the pharmacist and pharmacy who are providing pharmacy services
~As the Federal Register states that emergency kits in Long Term Care Facilities are only viewed as compliant with the Controlled Substance Act IF the appropriate state agency or regulatory authority specifically approves such placement anltLQ()lgates procedures which delineate The Utah Department of Health is not the appropriate state agency and moreover the appropriate Utah statute conflicts with the inappropriate state agency administrative rules
~ Additionally the existing administrative rules do not define and cover everything mandated in the Federal Register to even be considered compliant
Page 5 of 6
State of Utah Department of Comnlerce Division of Occupational and Professional Licensing
GARY R HERBERT FRANCINEA GIANI MARK B STEINAGEL GOlernnr Executive Director DiviSIOn Director
GUIDELINES FOR HOSPITAL PHARMACIES and EMERGENCY DEPARTMENT TREATMENT
Approved by the Board of Pharmacy May 21 2012
The pharmacist is responsible for all pharmacy practice as del ineated under Utah Code 58-17b and 58-37fto include
bull ordering receiving and stocking bull filling drug carts drug rooms emergency drug stocks bull controlling inventory including audit trail [or each controlled substance bull maintaining and adhering to policies and protocols that maintain controls over controlled
substances (Utah Controlled Substances Act Subsection R156-37-502 defines unprofessional conduct to include (4) failing to maintain controls over controlled substances which would be considered by a prudent practitioner to be effective against diversion theft or shortage of controlled substances (5) being unable to account for shortages of controlled substances for any controlled substance inventory for which the licensee has responsibility)
bull reviewing Medication Proof of Use forms or logs returned to the pharmacist for purposes of review and reconciliation and
bull submitting all required controlled substance prescription information to the Controlled Substance Database pursuant to Utah Code 58-37f-203
NOTE Responsible means accountable for The pharmacist may delegate the task yet is ultimately accountable for the outcome Final checks of medications or medication profiles cannot be delegated
After-hours Medications Taken from Pharmacy When a Pharmacy is Closed
Only a pharmacist nurse supervisor or charge nurse can enter the pharmacy when the bull pharmacy is closed Medications can only be taken from the pharmacy on an emergency as needed basis Abull medication log must be used to keep a per medication inventory Only a pharmacist nurse supervisor or charge nurse can have access and the alarm code bull to whel1_~ltj)armacL~19~~~alth0lglil~one~~tthe p(irmacist can _~~___ ~ have a key to the locked controlled substance inventory in the pharmacy The pharmacy must still be equipped with a security system to permit detection of entry at all times when the facility is closed An adequate security system for inpatient phannacies within hospitals would be a system similar to a badge reader access which could uniquely store and retain which authorized person had made entry into the pharmacy after regular hours
wwwdoplulahgoYmiddot Heber M Wells Buildingmiddot 160 East300 South PO Box 146741 Salt Lake City UT 84114-6741 telephone (801) 530-6628 bull tollmiddot free in Utah (866) 275-3675 bull fax (801) 530-651 1 bull investigations fax (801) 530middot630 I UTAH
Dispensing of Drugs from an Emergency Room
bull Emergency room staff including the prescribing practitioner or Iicensed nurse cannot dispense prescriptions to a patient The prescribing practitioner can give an emergency supply which is properly labeled to a patient to get a patient started on the medication until a pharmacy is open This is not to be construed to allow a prescribing practitioner to give out an entire prescription amount
The related community standard for the treatment of typical Emergency Department conditions and STI prophylaxis is seven days
bull Such emergency doses of medications shall be labelcd with at least -Prescribing practitioners name and facility name and telephone number -Patients name -Name ormedication and strength -Number oftablets given -Date given and -I nstrLlctions for use
bull Records of controlled substances dispensed by the prescribing practitioner must be provided to the pharmacy so that applicable prescription data can be reported to the CSD
NOTE Physicians may give out samples which are clearly marked as a sample not for resale unti I the patient can get to a pharmacy or to try the medication for possible untoward effects Samples must be dispensed pursuant to Utah Code Annotated sect 58shy17b-610
Repackaging bull It is illegal for retail phannacies to repackage medications for resale to hospitals clinics
or other pharmacies The hospital pharmacy could legally repackage medications for use in its own institution
Federal Statute
According to Federal regulations repackaging requires a manufacturers license as stated in US Code 21-130001(27) and USC 21-1301lI(a)
USC 21-130001 reads Manufacture means the producing preparation propagation compounding or processing of a drug or other substance or the packaging or repackaging of such substance or the labeling or relabeling of the commercial container of such substance but
~----- middotmiddotmiddotmiddot_~aoesmmiddotnot IncluOelne-aCliiities omiddotf-a-praclilioifef-wlio~middotasan1nci(rentwhlS1hmiddoteraoffilnistratle)ffT5f-
dispensing such substance in the course of hisher professional practice prepares compounds packages or labels such substance
USC 21-130111 (a) reads Every person who manufactures distributes dispenses imports or exports any controlled substances or who proposes to engage in the manufacture distribution dispensing importation or exportation of any controlled substances shall obtain a registration
wwwdoptutahgovmiddot Heber M Wells Buildingmiddot 160 East 300 Southmiddot PO Box 146741 Salt Lake City UT 84114-6741 telephone (801) 530-6628middot toll-free in Utah (866) 275-3675 fax (801) 530-6511 investigations fax (801) 530-6301
LEGISLA TIVE GENERAL COUNSEL SB178 ct Approved for Filing Sc Allred ct
ct 02-05-14 1 56 PM ct
1 CONTROLLED SUBSTANCE DATABASE MODIFICATIONS
2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Evan J Vickers
5 House Sponsor Bradley G Last
6
7 LONG TITLE
8 General Description
9 This bill modifies the Controlled Substance Database Act regarding access by pharmacy
10 technicians
11 Highlighted Provisions
12 This bill
13 ~ allows the phannacist-in-charge to designate a licensed phannacy technician to have
14 access to the database on behalf of the phannacist in accordance with statutory
15 requirements
16 Money Appropriated in this Bill
17 None
18 Other Special Clauses
19 None
20 Utah Code Sections Affected
21 AMENDS
22 58-37fmiddot301 as last amended by Laws of Utah 2013 Chapters 12 130 and 262
23
24 Be it enacted by the Legislature ofthe state ofUtah
25
26
27
Section 1 Section 58-37fmiddot301 is amended to read
58-37fmiddot301 Access to database
(1) The division shall make rules in accordance with Title 63G Chapter 3 Utah
rJlbull =bull
1111111111111111111111111111111111111111
02-05-14 156 PM SB178
59 (A) fit within the responsibilities of the Department of Health for health and welfare
60 (B) are reviewed and approved by an Institutional Review Board that is approved for
61 human subject research by the United States Department of Health and Human Services and
62 (C) are not conducted for profit or commercial gain and
63 (D) are conducted in a research facility as defined by division rule that is associated
64 with a university or college in the state accredited by the Northwest Commission on Colleges
65 and Universities
66 (iii) the designee protects the information as a business associate of the Department of
67 Health and
68 (iv) the identity of the prescribers patients and pharmacies in the database are
69 de-identified confidential not disclosed in any manner to the designee or to any individual
70 who is not directly involved in the scientific studies
71 (e) a licensed practitioner having authority to prescribe controlled substances to the
72 extent the information
73 (i) (A) relates specifically to a current or prospective patient of the practitioner and
74 (B) is provided to or sought by the practitioner for the purpose of
75 (I) prescribing or considering prescribing any controlled substance to the current or
76 prospective patient
77 (II) diagnosing the current or prospective patient
78 (nn providing medical treatment or medical advice to the current or prospective
79 patient or
80 (IV) determining whether the current or prospective patient
81 (Aa) is attempting to fraudulently obtain a controlled substance from the practitioner
82 or
83 (Bb) has fraudulently obtained or attempted to fraudulently obtain a controlled
84 substance from the practitioner
85 (ii) (A) relates specifically to a fonner patient of the practitioner and
86 (B) is provided to or sought by the practitioner for the purpose of determining whether
87 the former patient has fraudulently obtained or has attempted to fraudulently obtain a
88 controlled substance from the practitioner
89 (iii) relates specifically to an individual who has access to the practitioners Drug
- 3 shy
02-05-14 156 PM SB178
121 58-3 7f-203(3 )(b) with respect to the employee
122 (h) a licensed pharmacist having authority to dispense a controlled substance to the
123 extent the information is provided or sought for the purpose of
124 (i) dispensing or considering dispensing any controlled substance or
125 (ii) determining whether a person
126 (A) is attempting to fraudulently obtain a controlled substance from the pharmacist or
127 (B) has fraudulently obtained or attempted to fraudulently obtain a controlled
128 substance from the pharmacist
129 (i) in accordance with Subsection (3)(a) a licensed pharmacy technician who is an
]30 employee of a pharmacy as defined in Section 58-17b-l 02 for the purposes described in
131 Subsection (2)(h)(i) or (iO if
132 0) the employee is designated by the pharmacist-in-charge as an individual authorized
133 to access the information on behalf of a licensed pharmacist employed by the pharmacy
134 (ii) the pharmacist-in-charge provides written notice to the division of the identity of
135 the employee and
136 (iii) the division
137 CA) grants the employee access to the database and
138 (B) provides the employee with a password that is unique to that employee to access
139 the database in order to permit the division to comply with the requirements of Subsection
140 58-37f-203(3)(b) with respect to the employee
141 [fiJ] ill federal state and local law enforcement authorities and state and local
142 prosecutors engaged as a specified duty of their employment in enforcing laws
143 (i) regulating controlled substances
144 (ii) investigating insurance fraud Medicaid fraud or Medicare fraud or
145 (iii) providing information about a criminal defendant to defense counsel upon request
146 during the discovery process for the purpose of establishing a defense in a criminal case
147 [61] fhl employees ofthe Office oflntemal Audit and Program Integrity within the
148 Department of Health who are engaged in their specified duty of ensuring Medicaid program
149 integrity under Section 26-18-23
150 [fki] ill a mental health therapist if
151 (i) the information relates to a patient who is
- 5 shy
02-05-14 156 PM SB178
183 designated under Subsection (2)(f) (2)(g) or (4)(c) should be granted access to the database
184 and
185 (ii) establish the information to be provided by an emergency room employee under
186 Subsection (4)
187 (c) The division shall grant an employee designated under Subsection (2)(f) (2)(g) or
188 (4)( c) access to the database unless the division determines based on a background check that
189 the employee poses a security risk to the information contained in the database
190 (4) (a) An individual who is employed in the emergency room ofa hospital may
191 exercise access to the database under this Subsection (4) on behalf of a licensed practitioner if
192 the individual is designated under Subsection (4)( c) and the licensed practitioner
193 (i) is employed in the emergency room
194 Oi) is treating an emergency room patient for an emergency medical condition and
195 (iii) requests that an individual employed in the emergency room and designated under
196 Subsection (4)( c) obtain information regarding the patient from the database as needed in the
197 course of treatment
198 (b) The emergency room employee obtaining information from the database shall
199 when gaining access to the database provide to the database the name and any additional
200 identifiers regarding the requesting practitioner as required by division administrative rule
201 established under Subsection (3)(b)
202 (c) An individual employed in the emergency room under this Subsection (4) may
203 obtain information from the database as provided in Subsection (4)(a) if
204 (i) the employee is designated by the practitioner as an individual authorized to access
205 the information on behalf of the practitioner
206 (ii) the practitioner and the hospital operating the emergency room provide written
207 notice to the division of the identity of the designated employee and
208 (iii) the division
209 (A) grants the employee access to the database and
210 (B) provides the employee with a password that is unique to that employee to access
211 the database in order to permit the division to comply with the requirements of Subsection
212 58-37f-203(3)(b) with respect to the employee
213 (d) The division may impose a fee in accordance with Section 63J-I-504 on a
- 7
LEGISLATIVE GENERAL C01JNSEL SB55 iL Approved for Filing Cl Dupont iL lst Sub (Green)
iL 02-07-14 416 PM iL
Senator Evan J Vickers proposes the following substitute bill
PHARMACEUTICAL DISPENSING AMENDMENTS
2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Evan J Vickers
5 House Sponsor Stewart Barlow
6
7 LONG TITLE
8 General Description
9 This bill amends the Pharmacy Practice Act to create a dispensing medical practitioner
10 license and a license classification for a dispensing medical practitioner clinic
11 pharmacy
12 Highlighted Provisions
13 This bill
14 defines terms
15 establishes the license classification dispensing medical practitioner under the
16 Pharmacy Practice Act for medical practitioners who prescribe and dispense a drug
17 establishes the pharmacy facility license classification dispensing medical
18 practitioner clinic pharmacy under the Pharmacy Practice Act
19 creates Part 8 Dispensing Medical Practitioner and Dispensing Medical Practitioner
20 Clinic Pharmacy
21 removes the exemption from the Pharmacy Practice Act for medical practitioners
22 who prescribe and dispense a cosmetic drug injectable weight loss drug or a cancer
23 drug treatment regimen
24 requires a license as a dispensing medical practitioner for a health care practitioner 00
25 to dispense bull bull=
1111111111111111111111111111111111111111111111111111111
02-07-14 416 PM 1st Sub (Green) SB 55
615 Practitioner Clinic Pharmacy II
616 Section 8 Section 58-17b-802 is enacted to read
617 58-17b-802 Definitions
618 As used in this part
619 (1) (a) Cosmetic drug means a prescription drug that
620 (i) is for the purpose of promoting attractiveness or altering the appearance of an
621 individual and
622 (ii) (A) is listed as a cosmetic drug subject to the exemption under this section by the
623 division by administrative rule or
624 CB) has been expressly approved for online dispensing whether or not it is dispensed
625 online or through a physicians office
626 (b) Cosmetic drug does not include a prescription drug that is
627 (i) a controlled substance
628 (ii) compounded by the physician or
629 (iii) prescribed or used for the patient for the purpose of diagnosing curing or
630 preventing a disease
631 (2) Employer sponsored clinic means an entity that S-t has a medical director who is
631 a licensed as a physician as defined in Section 58-67-102 and S offers health care only to the
632 employees of an exclusive group of employers and the employees dependents
633 (3) Health care is as defined in Section 31A-1-301
634 (4) Ca) Injectable weight loss drug means an injectable prescription drug
635 (n prescribed to promote weight loss and
636 (ii) listed as an injectable prescription drug subject to exemption under this section by
637 the division by administrative rule
638 (b) Injectable weight loss drug does not include a prescription drug that is a
639 controlled substance
640 (5) Prepackaged drug means a prescription drug that
641 (a) is not listed under federal or state law as a Schedule I II ill IV or V drug and
642 (b) is packaged in a fixed quantity per package by
643 (i) the drug manufacturer
644 (ii) a pharmaceutical wholesaler or distributor or
645 (iii) a pharmacy licensed under this title
- 21 Senate Committee Amendments 2-13-2014 Jplcjd
1st Sub (Green) SB 55 02-07-14 416 PM
646 Section 9 Section 58-17b-803 is enacted to read
647 58-17b-803 Qualifications for licensure as a dispensing medical practitioner -shy
648 Scope of practice
649 (1) An applicant for a license as a dispensing medical practitioner shall
650 (a) be licensed in good standing under at least one of the chapters listed in Subsection
651 58-17b-l02(23)(a) and
652 (b) submit an application for a license as a dispensing medical practitioner in a form
653 prescribed by the division and pay a fee established by the S [depal tment] divisionS ~
654 (2) The division shall accept the licensing in good standing under Subsection (1) in lieu
655 of requiring an applicant for a license under this part to comply with Sections 58-17b-303 and
656
657 (3) A dispensing medical practitioner may dispense in accordance with this part
658 (a) a cosmetic drug and an injectable weight loss drug if
659 (i) the drug was prescribed by the dispensing medical practitioner to the dispensing
660 medical practitioners patient and
661 Oi) the dispensing medical practitioner complies with administrative rules adopted by
662 the division under Subsection 58-17-802(1)
663 (b) a cancer drug treatment regimen if the dispensing medical practitioner complies
664 with Section 58-17b-805 and
665 (c) a pre-packaged drug to an employee or a dependent of an employee at an employer
666 sponsored clinic if the dispensing medical practitioner
667 (i) treats an employee or the dependent of an employee of one of an exclusive group
668 of employers at an employer sponsored clinic
669 (ii) prescribes a prepackaged drug to the employee or the employees dependent
670 (iii) dispenses the prepackaged drug at the employer sponsored clinic and
671 (iv) complies with administrative rules adopted by the division in consultation with the
672 Board of Pharmacy that establish labeling record keeping patient counseling purchasing and
673 distribution operating treatment quality of care and storage requirements
674 (4) A dispensing medical practitioner
675 Ca) shall inform the patient
676 (i) that the drug dispensed by the practitioner may be obtained from a pharmacy
- 22 - Senate Committee Amendments 2-13-2014 picjd
02-07-14 416 PM 1st Sub (Green) SB 55
739 58-17b-806 Dispensing medical practitioner -- Dispensing medical practitioner
740 clinic pharmacy -- Unprofessional and Unlawful conduct
741 ill S Ull S The division S [ iii consultation witb tile boal d shall
742 (a) I epol t a violation of this chapter b a dispensing medical pi actitiollel to] shall consult
742a with S the
743 dispensing medical practitioners appropriate licensing board as designated in Subsection
744 5S-17b-l02(23)(a) S reeardine a violation oftMs chapterS and
745 (hl S the Pharmacy Board shall if requested by the licensine board of the dispensine
745a medical practitionerS assist the licensing board for the dispensing medical practitioner with
745b reviewing the
746 violations of the provisions of this chapter
747 (2) The division S [ in collabOi atioll with the Boal d ofPhall1l3C]S may take
747a appropriate
748 action against a dispensing medical practitioner in accordance with this chapter if the
749 licensing board designated in Subsection 58-17b- 02(23)(a) recommends to the division that
750 action be taken under this chapter
751 (3) The division in consultation with the board is the primary enforcer under this
752 chapter for a dispensing medical practitioner clinic pharmacy licensed under Section
753 58-17b-804
754 Section 13 Section 58-31b-502 is amended to read
755 58-31b-502 Unprofessional conduct
756 Unprofessional conduct includes
757 (l) failure to safeguard a patients right to privacy as to the patients person condition
758 diagnosis personal effects or any other matter about which the licensee is privileged to know
759 because of the licensees or person with a certifications position or practice as a nurse or
760 practice as a medication aide certified
761 (2) failure to provide nursing service or service as a medication aide certified in a
762 manner that demonstrates respect for the patients human dignity and unique personal character
763 and needs without regard to the patients race religion ethnic background socioeconomic
764 status age sex or the nature of the patients health problem
765 (3) engaging in sexual relations with a patient during any
766 (a) period when a generally recognized professional relationship exists between the
767 person licensed or certified under this chapter and patient or
768 (b) extended period when a patient has reasonable cause to believe a professional
769 relationship exists between the person licensed or certified under the provisions of this chapter
- 25 - Senate Committee Amendments 2-13-2014Iplcjd
LEGISLA TIVE GENERAL COUNSEL SB138 ct Approved for Filing Sc Allred ct
ct 02-04-14 1220 PM ct
1 CONTROLLED SUBSTANCES ACT AMENDMENTS
2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Evan J Vickers
5 House Sponsor Stewart Barlow
6
7 LONG TITLE
8 General Description
9 This bill modifies the Utah Controlled Substances Act regarding prescriptions for
10 controlled substances
11 Highlighted Provisions
12 This bill
13 ~ provides that more than one controlled substance may be included in a prescription
14 Money Appropriated in this Bill
15 None
16 Other Special Clauses
17 None
18 Utah Code Sections Affected
19 AMENDS
20 58-37-6 as last amended by Laws of Utah 2012 Chapter 272
21
22 Be it enacted by the Legislature of the state ofUtah
23 Section 1 Section 58-37-6 is amended to read
24 58-37-6 License to manufacture produce distribute dispense administer or
25 conduct research -- Issuance by division -- Denial suspension or revocation -- Records
26
27
required -- Prescriptions
(1) (a) The division may adopt rules relating to the licensing and control of the bull
1111111111111111111111111111111111111111
SB138 02-04-14 1220 PM
214 (ii) the prescribed controlled substance is to be used in research
215 (f) Except when administered directly to an ultimate user by a licensed practitioner
216 controlled substances are subject to the following restrictions
217 (i) (A) A prescription for a Schedule IT substance may not be refilled
218 (B) A Schedule II controlled substance may not be filled in a quantity to exceed a
219 one-months supply as directed on the daily dosage rate of the prescriptions
220 (ii) A Schedule ill or IV controlled substance may be filled only within six months of
221 issuance and may not be refilled more than six months after the date of its original issuance or
222 be refilled more than five times after the date of the prescription unless renewed by the
223 practitioner
224 (iii) All other controlled substances in Schedule V may be refilled as the prescribers
225 prescription directs but they may not be refilled one year after the date the prescription was
226 issued unless renewed by the practitioner
227 (iv) Any prescription for a Schedule IT substance may not be dispensed if it is not
228 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days
229 after the date the prescription was issued or 30 days after the dispensing date if that date is
230 specified separately from the date of issue
231 (v) A practitioner may issue more than one prescription at the same time for the same
232 Schedule IT controlled substance but only under the following conditions
233 (A) no more than three prescriptions for the same Schedule IT controlled substance may
234 be issued at the same time
235 (B) no one prescription may exceed a 30-day supply
236 (C) a second or third prescription shall include the date of issuance and the date for
237 dispensing and
238 (D) unless the practitioner determines there is a valid medical reason to the contrary
239 the date for dispensing a second or third prescription may not be fewer than 30 days from the
240 dispensing date of the previous prescription
241 [(1i) Each prescription rot a controlled snbstance may eontain only one controlled
242 substance per pIescription frlim and may not contain any other legend dmg 01 prescription
243 item]
244 (g) An order for a controlled substance in Schedules IT through V for use by an
- 8 shy
LEGISLATIVE GENERAL COUNSEL it Approved for Filing CJ Dupont it
HB114
it 02-06-14855 AM it
1 MAIL-ORDER WHOLESALE DRUG AMENDMENTS 2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Stewart Barlow
5 Senate Sponsor ______
6
7 LONG TITLE
8 General Description
9 This bill amends the Pharmacy Practice Act
10 Highlighted Provisions
11 This bill
12 ~ amends the definition of a class C pharmacy subject to regulation under the
13 Pharmacy Practice Act
14 Money Appropriated in this Bill
15 None
16 Other Special Clauses
17 This bi II takes effect on July 1 2014
18 Utah Code Sections Affected
19 AMENDS
20 58-17b-102 as last amended by Laws of Utah 2013 Chapters 52 166 and 423
21
22 Be it enacted by the Legislature ofthe state ofUtah
23 Section 1 Section 58-17b-102 is amended to read
24 58-17b-102 Definitions
25 In addition to the definitions in Section 58-1-102 as used in this chapter
26
27
(1) Administering means
(a) the direct application of a prescription drug or device whether by injection
==bull =bull
1111111111111111111111111111111111111111
02-06-14855 AM HB114
59 (9) Centralized prescription processing means the processing by a pharmacy of a
60 request from another pharmacy to fill or refill a prescription drug order or to perform
61 processing functions such as dispensing drug utilization review claims adjudication refill
62 authorizations and therapeutic interventions
63 (10) Class A pharmacy means a pharmacy located in Utah that is authorized as a
64 retail pharmacy to compound or dispense a drug or dispense a device to the public under a
65 prescription order
66 (11) Class B pharmacy
67 (a) means a pharmacy located in Utah
68 (i) that is authorized to provide pharmaceutical care for patients in an institutional
69 setting and
70 (ii) whose primary purpose is to provide a physical environment for patients to obtain
71 health care services and
72 (b) (i) includes closed-door hospital clinic nuclear and branch pharmacies and
73 (ii) pharmaceutical administration and sterile product preparation facilities
74 (12) Class C pharmacy means a pharmacy [located ill Utah that is anthOl ized to
75 engage] that engages in the manufacture production wholesale or distribution of drugs or
76 devices in Utah
77 (13) Class D pharmacy means a nonresident pharmacy
78 (14) Class E pharmacy means all other pharmacies
79 (15) Closed-door pharmacy means a pharmacy that provides pharmaceutical care to a
80 defined and exclusive group of patients who have access to the services of the pharmacy
81 because they are treated by or have an affiliation with a specific entity including a health
82 maintenance organization or an infusion company but not including a hospital pharmacy a
83 retailer of goods to the general public or the office of a practitioner
84 (16) Collaborative pharmacy practice means a practice of pharmacy whereby one or
85 more pharmacists have jointly agreed on a voluntary basis to work in conjunction with one or
86 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical
87 care functions authorized by the practitioner or practitioners under certain specified conditions
88 or limitations
89 (17) Collaborative pharmacy practice agreement means a written and signed
- 3 shy
02-06-14855 AM HB114
369 and
370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in
371 collaboration with the board
372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501
373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and
374 may be further defined by rule
375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that
376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration
377 for animals
378 Section 2 Effective date
379 This bill takes effect on July I 2014
Legislative Review Note as of 2-4-14 1243 PM
Office of Legislative Research and General Counsel
- 13 shy
LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t
t 02-05-14 122PM t
1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG
2 AMENDMENTS
3 2014 GENERAL SESSION
4 STATE OF UTAH
5 Chief Sponsor Stewart Barlow
6 Senate Sponsor
7
8 LONG TITLE
9 General Description
10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from
11 its licensing requirements under certain circumstances
12 Highlighted Provisions
13 This bill
14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy
15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an
16 employer sponsored clinic and complies with other requirements
17 repeals subject to sunset review the provisions of this bill relating to the exemption
18 described above and
19 ~ makes technical and conforming changes
20 Money Appropriated in this Bill
21 None
22 Other Special Clauses
23 None
24 Utah Code Sections Affected
25 AMENDS
26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~
27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull
1111111111111111111111111111111111111111
HBI06 02-05-14 122 PM
28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278
29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234
30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351
31 ENACTS
32 58-17b-3097 Utah Code Annotated 1953
33
34 Be it enacted by the Legislature ofthe state ofUtah
35 Section 1 Section 58-17b-301 is amended to read
36 58-17b-301 License required -- License classifications for individuals
37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the
38 practice of a pharmacy technician except as specifically provided in Section 58-1-307
39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097
40 (2) The division shall issue to an individual who qualifies under this chapter a license
41 in the classification of
42 (a) pharmacist
43 (b) pharmacy intern or
44 (c) pharmacy technician
45 Section 2 Section 58-17b-302 is amended to read
46 58-17b-302 License required -- License classifications for pharmacy facilities
47 (l) A license is required to act as a pharmacy except as specifically exempted from
48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or
49
50 (2) The division shall issue a pharmacy license to a facility that qualifies under this
51 chapter in the classification of a
52 (a) class A pharmacy
53 (b) class B pharmacy
54 (c) class C pharmacy
55 (d) class D pharmacy or
56 (e) class E pharmacy
57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist
58 at the same address a separate license shall be required for each pharmacy
-2shy
02-05-14 122 PM HBI06
59 (4) The division may further define or supplement the classifications of pharmacies
60 The division may impose restrictions upon classifications to protect the public health safety
61 and welfare
62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by
63 rule
64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy
65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities
66 of the pharmacy regardless of the form of the business organization
67 Section 3 Section 58-17b-309 is amended to read
68 58-17b-309 Exemptions from licensure
69 (l) [For ptnp05C5 of] As used in this section
70 (a) Cosmetic drug
71 (i) means a prescription drug that is
72 (A) for the purpose of promoting attractiveness or altering the appearance of an
73 individual and
74 (8) listed as a cosmetic drug subject to the exemption under this section by the division
75 by administrative rule or has been expressly approved for online dispensing whether or not it is
76 dispensed online or through a physicians office and
77 (ii) does not include a prescription drug that is
78 (A) a controlled substance
79 (8) compounded by the physician or
80 (C) prescribed or used for the patient for the purpose of diagnosing curing or
81 preventing a disease
82 (b) Injectable weight loss drug
83 (i) means an injectable prescription drug
84 (A) prescribed to promote weight loss and
85 (8) listed as an injectable prescription drug subject to exemption under this section by
86 the division by administrative rule and
87 (ii) does not include a prescription drug that is a controlled substance
88 (c) Prescribing practitioner means an individual licensed under
89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with
- 3 shy
HB106 02-05-14 122 PM
90 prescriptive practice
91 (ii) Chapter 67 Utah Medical Practice Act
92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or
93 (iv) Chapter 70a Physician Assistant Act
94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l
95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the
96 acts or practices described in this section without being licensed under this chapter
97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the
98 individual notifies the division in writing of the individuals intent to dispense a drug under this
99 [snbsectioll] Subsection (2)
100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1
101 (c) an individual engaging in the practice of pharmacy technician under the direct
102 personal supervision of a pharmacist while making satisfactory progress in an approved
103 program as defined in division rule
104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an
105 injectable weight loss drug to the prescribing practitioners patient in accordance with
106 Subsection (4) or
107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists
108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic
109 drug to the optometrists patient in accordance with Subsection (4)
110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under
111 Subsection (2)( c) must take all examinations as required by division rule following completion
112 of an approved curriculum of education within the required time frame This exemption
113 expires immediately upon notification of a failing score of an examination and the individual
114 may not continue working as a pharmacy technician even under direct supervision
115 (4) A prescribing practitioner or optometrist is exempt from licensing under the
116 provisions of this part if the prescribing practitioner or optometrist
117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the
118 authority to dispense under Subsection (4)(b) and
119 (ii) informs the patient
120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing
-4shy
HB106 02-05-14 122 PM
152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the
153 prescribing practitioners or optometrists office and determine if the provisions of this section
154 are being met by the prescribing practitioner or optometrist
155 (d) If a prescribing practitioner or optometrist violates a provision of this section the
156 prescribing practitioner or optometrist may be subject to discipline under
157 (i) this chapter and
158 (ii) (A) Chapter 16a Utah Optometry Practice Act
159 (B) Chapter 31 b Nurse Practice Act
160 (C) Chapter 67 Utah Medical Practice Act
161 (D) Chapter 68 Utah Osteopathic Medical Practice Act
162 (E) Chapter 70a Physician Assistant Act or
163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act
164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the
165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah
166 Optometry Practice Act
167 Section 4 Section 58-17b-3095 is amended to read
168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy
169 Division study of dispensing practitioners
170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen
171 (a) means a prescription drug used to treat cancer manage its symptoms or provide
172 continuity of care for a cancer patient
173 (b) includes
174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal
175 methods and
176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize
177 physical and psychological symptoms or pain or to improve patient tolerance of cancer
178 treatments or prepare a patient for a subsequent course of therapy and
179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug
180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections
181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt
182 from licensure under this chapter
- 6shy
HB106 02-05-14 122 PM
214 (ii) is acting under the direction of a prescribing practitioner who is immediately
215 available on site for any necessary consultation and who has complied with Subsection
216 (2)(b)(i)
217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the
218 outpatient clinic setting and
219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)
220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to
221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section
222 (b) The evaluation under this Subsection (3) shall include
223 (i) practitioner compliance with the requirements of this section and Section
224 58-l7b-309
225 (ii) current research on dispensing and patient safety
226 (iii) survey of other state dispensing laws and
227 (iv) recommendations for future action concerning practitioner dispensing
228 (c) The division shall report to the Legislatures Health and Human Services Interim
229 Committee by November 302012 and by November 302013 with the results and
230 recommendations from the evaluation required by this Subsection (3)
231 (4) This section sunsets in accordance with Section 631-1-258
232 Section 5 Section 58-17b-3097 is enacted to read
233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an
234 employer sponsored clinic
235 (1) As used in this section
236 (a) Employer sponsored clinic means an entity that offers health care only to the
237 employees of an exclusive group of employers and the employees dependents
238 (b) Health care is as defined in Section 31 A-J-301
239 (c) Prepackaged drug means a prescription drug that
240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and
241 (ii) is packaged in a fixed quantity per package by
242 (A) the drug manufacturer
243 (B) a pharmaceutical wholesaler or distributor or
244 (C) a pharmacy licensed under this title
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~ -- -------------------
02-05-14 122 PM HB106
245 Cd) Prescribing practitioner is as defined in Section 58-17b-309
246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309
247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing
248 requirements of this chapter if the prescribing practitioner
249 Ca) treats an employee of one of an exclusive group of employers at an employer
250 sponsored clinic
251 Cb) prescribes a prepackaged drug to the employee
252 Cc) dispenses the prepackaged drug at the employer sponsored clinic
253 (d) notifies the division
254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the
255 employer sponsored clinic and
256 (ii) of the drug the prescribing practitioner intends to dispense
257 Ce) determines that providing the prepackaged drug to the employee at the employer
258 sponsored clinic is in the employees best interest
259 (f) informs the employee
260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner
261 from a pharmacy that is unaffiliated with the prescribing practitioner
262 (ii) of the directions for appropriate use of the prepackaged drug
263 (iii) of potential side effects to the use of the prepackaged drug and
264 (iv) how to contact the prescribing practitioner if the employee has questions or
265 concerns regarding the drug
266 (g) offers the employee the opportunity to consult with a pharmacist if the employee
267 asks for patient counseling and
268 (h) follows the administrative rules for a prescribing practitioner at an employer
269 sponsored clinic established by the division under Subsection (4)
270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a
271 prepackaged drug under this section requires physician supervision in its scope ofpractice
272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the
273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter
274 68 Utah Osteopathic Medical Practice Act
275 (4) The division shall in consultation with the board of pharmacy and the Physicians
- 9 shy
HBI06 02-05-14 122 PM
276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title
277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping
278 patient counseling purchasing and distribution operating treatment quality of care and
279 storage requirements for a prescribing practitioner at an employer sponsored clinic
280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a
281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing
282 practitioner is in compliance with this section
283 (6) If a prescribing practitioner violates a provision of this section the prescribing
284 practitioner may be subject to discipline under
285 (a) this chapter and
286 (b) any other chapter that governs the terms of the prescribing practitioners license
287 (7) The division shall evaluate the exemption created by this section and report to the
288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1
289 2018 on the results of the evaluation and the divisions recommendations regarding the
290 exemption
291 Section 6 Section 631-1-258 is amended to read
292 631-1-258 Repeal dates Title 58
293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is
294 repealed July 12016
295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015
296 (3) Section 58-17b-3095 is repealed July 1 2015
297 (4) Section 58-17b-3097 is repealed on July 12018
298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1
299 2018
300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1
301 2023
302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing
303 Act is repealed July 1 2019
304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1
305 2015
306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is
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02-05-14 1 22 PM HB106
307 repealed July 12023
308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1
309 2014
310 [ttej] ill) Section 58-69-3025 is repealed on July 12015
311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017
Legislative Review Note as of 2-3-14 418 PM
Office of Legislative Research and General Counsel
- 11 shy
bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull
Emergency Kit Compliance Overview Provided to DOPL on 2122014 by Jared Memmott
IMPORTANT POINTS
~ The practice of pharmacy definition and the above described statute prohibit anyone other than a properly licensed pharmacy from possessing stock controlled substances or legend drugs
~The Utah Department of Health has invalid and antiquated administrative rules that supersedes what statute does not allow and existing pharmacy law and rule does not even address some of the operating standards mandated by the pharmacist and pharmacy who are providing pharmacy services
~As the Federal Register states that emergency kits in Long Term Care Facilities are only viewed as compliant with the Controlled Substance Act IF the appropriate state agency or regulatory authority specifically approves such placement anltLQ()lgates procedures which delineate The Utah Department of Health is not the appropriate state agency and moreover the appropriate Utah statute conflicts with the inappropriate state agency administrative rules
~ Additionally the existing administrative rules do not define and cover everything mandated in the Federal Register to even be considered compliant
Page 5 of 6
State of Utah Department of Comnlerce Division of Occupational and Professional Licensing
GARY R HERBERT FRANCINEA GIANI MARK B STEINAGEL GOlernnr Executive Director DiviSIOn Director
GUIDELINES FOR HOSPITAL PHARMACIES and EMERGENCY DEPARTMENT TREATMENT
Approved by the Board of Pharmacy May 21 2012
The pharmacist is responsible for all pharmacy practice as del ineated under Utah Code 58-17b and 58-37fto include
bull ordering receiving and stocking bull filling drug carts drug rooms emergency drug stocks bull controlling inventory including audit trail [or each controlled substance bull maintaining and adhering to policies and protocols that maintain controls over controlled
substances (Utah Controlled Substances Act Subsection R156-37-502 defines unprofessional conduct to include (4) failing to maintain controls over controlled substances which would be considered by a prudent practitioner to be effective against diversion theft or shortage of controlled substances (5) being unable to account for shortages of controlled substances for any controlled substance inventory for which the licensee has responsibility)
bull reviewing Medication Proof of Use forms or logs returned to the pharmacist for purposes of review and reconciliation and
bull submitting all required controlled substance prescription information to the Controlled Substance Database pursuant to Utah Code 58-37f-203
NOTE Responsible means accountable for The pharmacist may delegate the task yet is ultimately accountable for the outcome Final checks of medications or medication profiles cannot be delegated
After-hours Medications Taken from Pharmacy When a Pharmacy is Closed
Only a pharmacist nurse supervisor or charge nurse can enter the pharmacy when the bull pharmacy is closed Medications can only be taken from the pharmacy on an emergency as needed basis Abull medication log must be used to keep a per medication inventory Only a pharmacist nurse supervisor or charge nurse can have access and the alarm code bull to whel1_~ltj)armacL~19~~~alth0lglil~one~~tthe p(irmacist can _~~___ ~ have a key to the locked controlled substance inventory in the pharmacy The pharmacy must still be equipped with a security system to permit detection of entry at all times when the facility is closed An adequate security system for inpatient phannacies within hospitals would be a system similar to a badge reader access which could uniquely store and retain which authorized person had made entry into the pharmacy after regular hours
wwwdoplulahgoYmiddot Heber M Wells Buildingmiddot 160 East300 South PO Box 146741 Salt Lake City UT 84114-6741 telephone (801) 530-6628 bull tollmiddot free in Utah (866) 275-3675 bull fax (801) 530-651 1 bull investigations fax (801) 530middot630 I UTAH
Dispensing of Drugs from an Emergency Room
bull Emergency room staff including the prescribing practitioner or Iicensed nurse cannot dispense prescriptions to a patient The prescribing practitioner can give an emergency supply which is properly labeled to a patient to get a patient started on the medication until a pharmacy is open This is not to be construed to allow a prescribing practitioner to give out an entire prescription amount
The related community standard for the treatment of typical Emergency Department conditions and STI prophylaxis is seven days
bull Such emergency doses of medications shall be labelcd with at least -Prescribing practitioners name and facility name and telephone number -Patients name -Name ormedication and strength -Number oftablets given -Date given and -I nstrLlctions for use
bull Records of controlled substances dispensed by the prescribing practitioner must be provided to the pharmacy so that applicable prescription data can be reported to the CSD
NOTE Physicians may give out samples which are clearly marked as a sample not for resale unti I the patient can get to a pharmacy or to try the medication for possible untoward effects Samples must be dispensed pursuant to Utah Code Annotated sect 58shy17b-610
Repackaging bull It is illegal for retail phannacies to repackage medications for resale to hospitals clinics
or other pharmacies The hospital pharmacy could legally repackage medications for use in its own institution
Federal Statute
According to Federal regulations repackaging requires a manufacturers license as stated in US Code 21-130001(27) and USC 21-1301lI(a)
USC 21-130001 reads Manufacture means the producing preparation propagation compounding or processing of a drug or other substance or the packaging or repackaging of such substance or the labeling or relabeling of the commercial container of such substance but
~----- middotmiddotmiddotmiddot_~aoesmmiddotnot IncluOelne-aCliiities omiddotf-a-praclilioifef-wlio~middotasan1nci(rentwhlS1hmiddoteraoffilnistratle)ffT5f-
dispensing such substance in the course of hisher professional practice prepares compounds packages or labels such substance
USC 21-130111 (a) reads Every person who manufactures distributes dispenses imports or exports any controlled substances or who proposes to engage in the manufacture distribution dispensing importation or exportation of any controlled substances shall obtain a registration
wwwdoptutahgovmiddot Heber M Wells Buildingmiddot 160 East 300 Southmiddot PO Box 146741 Salt Lake City UT 84114-6741 telephone (801) 530-6628middot toll-free in Utah (866) 275-3675 fax (801) 530-6511 investigations fax (801) 530-6301
LEGISLA TIVE GENERAL COUNSEL SB178 ct Approved for Filing Sc Allred ct
ct 02-05-14 1 56 PM ct
1 CONTROLLED SUBSTANCE DATABASE MODIFICATIONS
2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Evan J Vickers
5 House Sponsor Bradley G Last
6
7 LONG TITLE
8 General Description
9 This bill modifies the Controlled Substance Database Act regarding access by pharmacy
10 technicians
11 Highlighted Provisions
12 This bill
13 ~ allows the phannacist-in-charge to designate a licensed phannacy technician to have
14 access to the database on behalf of the phannacist in accordance with statutory
15 requirements
16 Money Appropriated in this Bill
17 None
18 Other Special Clauses
19 None
20 Utah Code Sections Affected
21 AMENDS
22 58-37fmiddot301 as last amended by Laws of Utah 2013 Chapters 12 130 and 262
23
24 Be it enacted by the Legislature ofthe state ofUtah
25
26
27
Section 1 Section 58-37fmiddot301 is amended to read
58-37fmiddot301 Access to database
(1) The division shall make rules in accordance with Title 63G Chapter 3 Utah
rJlbull =bull
1111111111111111111111111111111111111111
02-05-14 156 PM SB178
59 (A) fit within the responsibilities of the Department of Health for health and welfare
60 (B) are reviewed and approved by an Institutional Review Board that is approved for
61 human subject research by the United States Department of Health and Human Services and
62 (C) are not conducted for profit or commercial gain and
63 (D) are conducted in a research facility as defined by division rule that is associated
64 with a university or college in the state accredited by the Northwest Commission on Colleges
65 and Universities
66 (iii) the designee protects the information as a business associate of the Department of
67 Health and
68 (iv) the identity of the prescribers patients and pharmacies in the database are
69 de-identified confidential not disclosed in any manner to the designee or to any individual
70 who is not directly involved in the scientific studies
71 (e) a licensed practitioner having authority to prescribe controlled substances to the
72 extent the information
73 (i) (A) relates specifically to a current or prospective patient of the practitioner and
74 (B) is provided to or sought by the practitioner for the purpose of
75 (I) prescribing or considering prescribing any controlled substance to the current or
76 prospective patient
77 (II) diagnosing the current or prospective patient
78 (nn providing medical treatment or medical advice to the current or prospective
79 patient or
80 (IV) determining whether the current or prospective patient
81 (Aa) is attempting to fraudulently obtain a controlled substance from the practitioner
82 or
83 (Bb) has fraudulently obtained or attempted to fraudulently obtain a controlled
84 substance from the practitioner
85 (ii) (A) relates specifically to a fonner patient of the practitioner and
86 (B) is provided to or sought by the practitioner for the purpose of determining whether
87 the former patient has fraudulently obtained or has attempted to fraudulently obtain a
88 controlled substance from the practitioner
89 (iii) relates specifically to an individual who has access to the practitioners Drug
- 3 shy
02-05-14 156 PM SB178
121 58-3 7f-203(3 )(b) with respect to the employee
122 (h) a licensed pharmacist having authority to dispense a controlled substance to the
123 extent the information is provided or sought for the purpose of
124 (i) dispensing or considering dispensing any controlled substance or
125 (ii) determining whether a person
126 (A) is attempting to fraudulently obtain a controlled substance from the pharmacist or
127 (B) has fraudulently obtained or attempted to fraudulently obtain a controlled
128 substance from the pharmacist
129 (i) in accordance with Subsection (3)(a) a licensed pharmacy technician who is an
]30 employee of a pharmacy as defined in Section 58-17b-l 02 for the purposes described in
131 Subsection (2)(h)(i) or (iO if
132 0) the employee is designated by the pharmacist-in-charge as an individual authorized
133 to access the information on behalf of a licensed pharmacist employed by the pharmacy
134 (ii) the pharmacist-in-charge provides written notice to the division of the identity of
135 the employee and
136 (iii) the division
137 CA) grants the employee access to the database and
138 (B) provides the employee with a password that is unique to that employee to access
139 the database in order to permit the division to comply with the requirements of Subsection
140 58-37f-203(3)(b) with respect to the employee
141 [fiJ] ill federal state and local law enforcement authorities and state and local
142 prosecutors engaged as a specified duty of their employment in enforcing laws
143 (i) regulating controlled substances
144 (ii) investigating insurance fraud Medicaid fraud or Medicare fraud or
145 (iii) providing information about a criminal defendant to defense counsel upon request
146 during the discovery process for the purpose of establishing a defense in a criminal case
147 [61] fhl employees ofthe Office oflntemal Audit and Program Integrity within the
148 Department of Health who are engaged in their specified duty of ensuring Medicaid program
149 integrity under Section 26-18-23
150 [fki] ill a mental health therapist if
151 (i) the information relates to a patient who is
- 5 shy
02-05-14 156 PM SB178
183 designated under Subsection (2)(f) (2)(g) or (4)(c) should be granted access to the database
184 and
185 (ii) establish the information to be provided by an emergency room employee under
186 Subsection (4)
187 (c) The division shall grant an employee designated under Subsection (2)(f) (2)(g) or
188 (4)( c) access to the database unless the division determines based on a background check that
189 the employee poses a security risk to the information contained in the database
190 (4) (a) An individual who is employed in the emergency room ofa hospital may
191 exercise access to the database under this Subsection (4) on behalf of a licensed practitioner if
192 the individual is designated under Subsection (4)( c) and the licensed practitioner
193 (i) is employed in the emergency room
194 Oi) is treating an emergency room patient for an emergency medical condition and
195 (iii) requests that an individual employed in the emergency room and designated under
196 Subsection (4)( c) obtain information regarding the patient from the database as needed in the
197 course of treatment
198 (b) The emergency room employee obtaining information from the database shall
199 when gaining access to the database provide to the database the name and any additional
200 identifiers regarding the requesting practitioner as required by division administrative rule
201 established under Subsection (3)(b)
202 (c) An individual employed in the emergency room under this Subsection (4) may
203 obtain information from the database as provided in Subsection (4)(a) if
204 (i) the employee is designated by the practitioner as an individual authorized to access
205 the information on behalf of the practitioner
206 (ii) the practitioner and the hospital operating the emergency room provide written
207 notice to the division of the identity of the designated employee and
208 (iii) the division
209 (A) grants the employee access to the database and
210 (B) provides the employee with a password that is unique to that employee to access
211 the database in order to permit the division to comply with the requirements of Subsection
212 58-37f-203(3)(b) with respect to the employee
213 (d) The division may impose a fee in accordance with Section 63J-I-504 on a
- 7
LEGISLATIVE GENERAL C01JNSEL SB55 iL Approved for Filing Cl Dupont iL lst Sub (Green)
iL 02-07-14 416 PM iL
Senator Evan J Vickers proposes the following substitute bill
PHARMACEUTICAL DISPENSING AMENDMENTS
2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Evan J Vickers
5 House Sponsor Stewart Barlow
6
7 LONG TITLE
8 General Description
9 This bill amends the Pharmacy Practice Act to create a dispensing medical practitioner
10 license and a license classification for a dispensing medical practitioner clinic
11 pharmacy
12 Highlighted Provisions
13 This bill
14 defines terms
15 establishes the license classification dispensing medical practitioner under the
16 Pharmacy Practice Act for medical practitioners who prescribe and dispense a drug
17 establishes the pharmacy facility license classification dispensing medical
18 practitioner clinic pharmacy under the Pharmacy Practice Act
19 creates Part 8 Dispensing Medical Practitioner and Dispensing Medical Practitioner
20 Clinic Pharmacy
21 removes the exemption from the Pharmacy Practice Act for medical practitioners
22 who prescribe and dispense a cosmetic drug injectable weight loss drug or a cancer
23 drug treatment regimen
24 requires a license as a dispensing medical practitioner for a health care practitioner 00
25 to dispense bull bull=
1111111111111111111111111111111111111111111111111111111
02-07-14 416 PM 1st Sub (Green) SB 55
615 Practitioner Clinic Pharmacy II
616 Section 8 Section 58-17b-802 is enacted to read
617 58-17b-802 Definitions
618 As used in this part
619 (1) (a) Cosmetic drug means a prescription drug that
620 (i) is for the purpose of promoting attractiveness or altering the appearance of an
621 individual and
622 (ii) (A) is listed as a cosmetic drug subject to the exemption under this section by the
623 division by administrative rule or
624 CB) has been expressly approved for online dispensing whether or not it is dispensed
625 online or through a physicians office
626 (b) Cosmetic drug does not include a prescription drug that is
627 (i) a controlled substance
628 (ii) compounded by the physician or
629 (iii) prescribed or used for the patient for the purpose of diagnosing curing or
630 preventing a disease
631 (2) Employer sponsored clinic means an entity that S-t has a medical director who is
631 a licensed as a physician as defined in Section 58-67-102 and S offers health care only to the
632 employees of an exclusive group of employers and the employees dependents
633 (3) Health care is as defined in Section 31A-1-301
634 (4) Ca) Injectable weight loss drug means an injectable prescription drug
635 (n prescribed to promote weight loss and
636 (ii) listed as an injectable prescription drug subject to exemption under this section by
637 the division by administrative rule
638 (b) Injectable weight loss drug does not include a prescription drug that is a
639 controlled substance
640 (5) Prepackaged drug means a prescription drug that
641 (a) is not listed under federal or state law as a Schedule I II ill IV or V drug and
642 (b) is packaged in a fixed quantity per package by
643 (i) the drug manufacturer
644 (ii) a pharmaceutical wholesaler or distributor or
645 (iii) a pharmacy licensed under this title
- 21 Senate Committee Amendments 2-13-2014 Jplcjd
1st Sub (Green) SB 55 02-07-14 416 PM
646 Section 9 Section 58-17b-803 is enacted to read
647 58-17b-803 Qualifications for licensure as a dispensing medical practitioner -shy
648 Scope of practice
649 (1) An applicant for a license as a dispensing medical practitioner shall
650 (a) be licensed in good standing under at least one of the chapters listed in Subsection
651 58-17b-l02(23)(a) and
652 (b) submit an application for a license as a dispensing medical practitioner in a form
653 prescribed by the division and pay a fee established by the S [depal tment] divisionS ~
654 (2) The division shall accept the licensing in good standing under Subsection (1) in lieu
655 of requiring an applicant for a license under this part to comply with Sections 58-17b-303 and
656
657 (3) A dispensing medical practitioner may dispense in accordance with this part
658 (a) a cosmetic drug and an injectable weight loss drug if
659 (i) the drug was prescribed by the dispensing medical practitioner to the dispensing
660 medical practitioners patient and
661 Oi) the dispensing medical practitioner complies with administrative rules adopted by
662 the division under Subsection 58-17-802(1)
663 (b) a cancer drug treatment regimen if the dispensing medical practitioner complies
664 with Section 58-17b-805 and
665 (c) a pre-packaged drug to an employee or a dependent of an employee at an employer
666 sponsored clinic if the dispensing medical practitioner
667 (i) treats an employee or the dependent of an employee of one of an exclusive group
668 of employers at an employer sponsored clinic
669 (ii) prescribes a prepackaged drug to the employee or the employees dependent
670 (iii) dispenses the prepackaged drug at the employer sponsored clinic and
671 (iv) complies with administrative rules adopted by the division in consultation with the
672 Board of Pharmacy that establish labeling record keeping patient counseling purchasing and
673 distribution operating treatment quality of care and storage requirements
674 (4) A dispensing medical practitioner
675 Ca) shall inform the patient
676 (i) that the drug dispensed by the practitioner may be obtained from a pharmacy
- 22 - Senate Committee Amendments 2-13-2014 picjd
02-07-14 416 PM 1st Sub (Green) SB 55
739 58-17b-806 Dispensing medical practitioner -- Dispensing medical practitioner
740 clinic pharmacy -- Unprofessional and Unlawful conduct
741 ill S Ull S The division S [ iii consultation witb tile boal d shall
742 (a) I epol t a violation of this chapter b a dispensing medical pi actitiollel to] shall consult
742a with S the
743 dispensing medical practitioners appropriate licensing board as designated in Subsection
744 5S-17b-l02(23)(a) S reeardine a violation oftMs chapterS and
745 (hl S the Pharmacy Board shall if requested by the licensine board of the dispensine
745a medical practitionerS assist the licensing board for the dispensing medical practitioner with
745b reviewing the
746 violations of the provisions of this chapter
747 (2) The division S [ in collabOi atioll with the Boal d ofPhall1l3C]S may take
747a appropriate
748 action against a dispensing medical practitioner in accordance with this chapter if the
749 licensing board designated in Subsection 58-17b- 02(23)(a) recommends to the division that
750 action be taken under this chapter
751 (3) The division in consultation with the board is the primary enforcer under this
752 chapter for a dispensing medical practitioner clinic pharmacy licensed under Section
753 58-17b-804
754 Section 13 Section 58-31b-502 is amended to read
755 58-31b-502 Unprofessional conduct
756 Unprofessional conduct includes
757 (l) failure to safeguard a patients right to privacy as to the patients person condition
758 diagnosis personal effects or any other matter about which the licensee is privileged to know
759 because of the licensees or person with a certifications position or practice as a nurse or
760 practice as a medication aide certified
761 (2) failure to provide nursing service or service as a medication aide certified in a
762 manner that demonstrates respect for the patients human dignity and unique personal character
763 and needs without regard to the patients race religion ethnic background socioeconomic
764 status age sex or the nature of the patients health problem
765 (3) engaging in sexual relations with a patient during any
766 (a) period when a generally recognized professional relationship exists between the
767 person licensed or certified under this chapter and patient or
768 (b) extended period when a patient has reasonable cause to believe a professional
769 relationship exists between the person licensed or certified under the provisions of this chapter
- 25 - Senate Committee Amendments 2-13-2014Iplcjd
LEGISLA TIVE GENERAL COUNSEL SB138 ct Approved for Filing Sc Allred ct
ct 02-04-14 1220 PM ct
1 CONTROLLED SUBSTANCES ACT AMENDMENTS
2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Evan J Vickers
5 House Sponsor Stewart Barlow
6
7 LONG TITLE
8 General Description
9 This bill modifies the Utah Controlled Substances Act regarding prescriptions for
10 controlled substances
11 Highlighted Provisions
12 This bill
13 ~ provides that more than one controlled substance may be included in a prescription
14 Money Appropriated in this Bill
15 None
16 Other Special Clauses
17 None
18 Utah Code Sections Affected
19 AMENDS
20 58-37-6 as last amended by Laws of Utah 2012 Chapter 272
21
22 Be it enacted by the Legislature of the state ofUtah
23 Section 1 Section 58-37-6 is amended to read
24 58-37-6 License to manufacture produce distribute dispense administer or
25 conduct research -- Issuance by division -- Denial suspension or revocation -- Records
26
27
required -- Prescriptions
(1) (a) The division may adopt rules relating to the licensing and control of the bull
1111111111111111111111111111111111111111
SB138 02-04-14 1220 PM
214 (ii) the prescribed controlled substance is to be used in research
215 (f) Except when administered directly to an ultimate user by a licensed practitioner
216 controlled substances are subject to the following restrictions
217 (i) (A) A prescription for a Schedule IT substance may not be refilled
218 (B) A Schedule II controlled substance may not be filled in a quantity to exceed a
219 one-months supply as directed on the daily dosage rate of the prescriptions
220 (ii) A Schedule ill or IV controlled substance may be filled only within six months of
221 issuance and may not be refilled more than six months after the date of its original issuance or
222 be refilled more than five times after the date of the prescription unless renewed by the
223 practitioner
224 (iii) All other controlled substances in Schedule V may be refilled as the prescribers
225 prescription directs but they may not be refilled one year after the date the prescription was
226 issued unless renewed by the practitioner
227 (iv) Any prescription for a Schedule IT substance may not be dispensed if it is not
228 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days
229 after the date the prescription was issued or 30 days after the dispensing date if that date is
230 specified separately from the date of issue
231 (v) A practitioner may issue more than one prescription at the same time for the same
232 Schedule IT controlled substance but only under the following conditions
233 (A) no more than three prescriptions for the same Schedule IT controlled substance may
234 be issued at the same time
235 (B) no one prescription may exceed a 30-day supply
236 (C) a second or third prescription shall include the date of issuance and the date for
237 dispensing and
238 (D) unless the practitioner determines there is a valid medical reason to the contrary
239 the date for dispensing a second or third prescription may not be fewer than 30 days from the
240 dispensing date of the previous prescription
241 [(1i) Each prescription rot a controlled snbstance may eontain only one controlled
242 substance per pIescription frlim and may not contain any other legend dmg 01 prescription
243 item]
244 (g) An order for a controlled substance in Schedules IT through V for use by an
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LEGISLATIVE GENERAL COUNSEL it Approved for Filing CJ Dupont it
HB114
it 02-06-14855 AM it
1 MAIL-ORDER WHOLESALE DRUG AMENDMENTS 2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Stewart Barlow
5 Senate Sponsor ______
6
7 LONG TITLE
8 General Description
9 This bill amends the Pharmacy Practice Act
10 Highlighted Provisions
11 This bill
12 ~ amends the definition of a class C pharmacy subject to regulation under the
13 Pharmacy Practice Act
14 Money Appropriated in this Bill
15 None
16 Other Special Clauses
17 This bi II takes effect on July 1 2014
18 Utah Code Sections Affected
19 AMENDS
20 58-17b-102 as last amended by Laws of Utah 2013 Chapters 52 166 and 423
21
22 Be it enacted by the Legislature ofthe state ofUtah
23 Section 1 Section 58-17b-102 is amended to read
24 58-17b-102 Definitions
25 In addition to the definitions in Section 58-1-102 as used in this chapter
26
27
(1) Administering means
(a) the direct application of a prescription drug or device whether by injection
==bull =bull
1111111111111111111111111111111111111111
02-06-14855 AM HB114
59 (9) Centralized prescription processing means the processing by a pharmacy of a
60 request from another pharmacy to fill or refill a prescription drug order or to perform
61 processing functions such as dispensing drug utilization review claims adjudication refill
62 authorizations and therapeutic interventions
63 (10) Class A pharmacy means a pharmacy located in Utah that is authorized as a
64 retail pharmacy to compound or dispense a drug or dispense a device to the public under a
65 prescription order
66 (11) Class B pharmacy
67 (a) means a pharmacy located in Utah
68 (i) that is authorized to provide pharmaceutical care for patients in an institutional
69 setting and
70 (ii) whose primary purpose is to provide a physical environment for patients to obtain
71 health care services and
72 (b) (i) includes closed-door hospital clinic nuclear and branch pharmacies and
73 (ii) pharmaceutical administration and sterile product preparation facilities
74 (12) Class C pharmacy means a pharmacy [located ill Utah that is anthOl ized to
75 engage] that engages in the manufacture production wholesale or distribution of drugs or
76 devices in Utah
77 (13) Class D pharmacy means a nonresident pharmacy
78 (14) Class E pharmacy means all other pharmacies
79 (15) Closed-door pharmacy means a pharmacy that provides pharmaceutical care to a
80 defined and exclusive group of patients who have access to the services of the pharmacy
81 because they are treated by or have an affiliation with a specific entity including a health
82 maintenance organization or an infusion company but not including a hospital pharmacy a
83 retailer of goods to the general public or the office of a practitioner
84 (16) Collaborative pharmacy practice means a practice of pharmacy whereby one or
85 more pharmacists have jointly agreed on a voluntary basis to work in conjunction with one or
86 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical
87 care functions authorized by the practitioner or practitioners under certain specified conditions
88 or limitations
89 (17) Collaborative pharmacy practice agreement means a written and signed
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02-06-14855 AM HB114
369 and
370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in
371 collaboration with the board
372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501
373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and
374 may be further defined by rule
375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that
376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration
377 for animals
378 Section 2 Effective date
379 This bill takes effect on July I 2014
Legislative Review Note as of 2-4-14 1243 PM
Office of Legislative Research and General Counsel
- 13 shy
LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t
t 02-05-14 122PM t
1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG
2 AMENDMENTS
3 2014 GENERAL SESSION
4 STATE OF UTAH
5 Chief Sponsor Stewart Barlow
6 Senate Sponsor
7
8 LONG TITLE
9 General Description
10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from
11 its licensing requirements under certain circumstances
12 Highlighted Provisions
13 This bill
14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy
15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an
16 employer sponsored clinic and complies with other requirements
17 repeals subject to sunset review the provisions of this bill relating to the exemption
18 described above and
19 ~ makes technical and conforming changes
20 Money Appropriated in this Bill
21 None
22 Other Special Clauses
23 None
24 Utah Code Sections Affected
25 AMENDS
26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~
27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull
1111111111111111111111111111111111111111
HBI06 02-05-14 122 PM
28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278
29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234
30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351
31 ENACTS
32 58-17b-3097 Utah Code Annotated 1953
33
34 Be it enacted by the Legislature ofthe state ofUtah
35 Section 1 Section 58-17b-301 is amended to read
36 58-17b-301 License required -- License classifications for individuals
37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the
38 practice of a pharmacy technician except as specifically provided in Section 58-1-307
39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097
40 (2) The division shall issue to an individual who qualifies under this chapter a license
41 in the classification of
42 (a) pharmacist
43 (b) pharmacy intern or
44 (c) pharmacy technician
45 Section 2 Section 58-17b-302 is amended to read
46 58-17b-302 License required -- License classifications for pharmacy facilities
47 (l) A license is required to act as a pharmacy except as specifically exempted from
48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or
49
50 (2) The division shall issue a pharmacy license to a facility that qualifies under this
51 chapter in the classification of a
52 (a) class A pharmacy
53 (b) class B pharmacy
54 (c) class C pharmacy
55 (d) class D pharmacy or
56 (e) class E pharmacy
57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist
58 at the same address a separate license shall be required for each pharmacy
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02-05-14 122 PM HBI06
59 (4) The division may further define or supplement the classifications of pharmacies
60 The division may impose restrictions upon classifications to protect the public health safety
61 and welfare
62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by
63 rule
64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy
65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities
66 of the pharmacy regardless of the form of the business organization
67 Section 3 Section 58-17b-309 is amended to read
68 58-17b-309 Exemptions from licensure
69 (l) [For ptnp05C5 of] As used in this section
70 (a) Cosmetic drug
71 (i) means a prescription drug that is
72 (A) for the purpose of promoting attractiveness or altering the appearance of an
73 individual and
74 (8) listed as a cosmetic drug subject to the exemption under this section by the division
75 by administrative rule or has been expressly approved for online dispensing whether or not it is
76 dispensed online or through a physicians office and
77 (ii) does not include a prescription drug that is
78 (A) a controlled substance
79 (8) compounded by the physician or
80 (C) prescribed or used for the patient for the purpose of diagnosing curing or
81 preventing a disease
82 (b) Injectable weight loss drug
83 (i) means an injectable prescription drug
84 (A) prescribed to promote weight loss and
85 (8) listed as an injectable prescription drug subject to exemption under this section by
86 the division by administrative rule and
87 (ii) does not include a prescription drug that is a controlled substance
88 (c) Prescribing practitioner means an individual licensed under
89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with
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HB106 02-05-14 122 PM
90 prescriptive practice
91 (ii) Chapter 67 Utah Medical Practice Act
92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or
93 (iv) Chapter 70a Physician Assistant Act
94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l
95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the
96 acts or practices described in this section without being licensed under this chapter
97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the
98 individual notifies the division in writing of the individuals intent to dispense a drug under this
99 [snbsectioll] Subsection (2)
100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1
101 (c) an individual engaging in the practice of pharmacy technician under the direct
102 personal supervision of a pharmacist while making satisfactory progress in an approved
103 program as defined in division rule
104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an
105 injectable weight loss drug to the prescribing practitioners patient in accordance with
106 Subsection (4) or
107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists
108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic
109 drug to the optometrists patient in accordance with Subsection (4)
110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under
111 Subsection (2)( c) must take all examinations as required by division rule following completion
112 of an approved curriculum of education within the required time frame This exemption
113 expires immediately upon notification of a failing score of an examination and the individual
114 may not continue working as a pharmacy technician even under direct supervision
115 (4) A prescribing practitioner or optometrist is exempt from licensing under the
116 provisions of this part if the prescribing practitioner or optometrist
117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the
118 authority to dispense under Subsection (4)(b) and
119 (ii) informs the patient
120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing
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HB106 02-05-14 122 PM
152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the
153 prescribing practitioners or optometrists office and determine if the provisions of this section
154 are being met by the prescribing practitioner or optometrist
155 (d) If a prescribing practitioner or optometrist violates a provision of this section the
156 prescribing practitioner or optometrist may be subject to discipline under
157 (i) this chapter and
158 (ii) (A) Chapter 16a Utah Optometry Practice Act
159 (B) Chapter 31 b Nurse Practice Act
160 (C) Chapter 67 Utah Medical Practice Act
161 (D) Chapter 68 Utah Osteopathic Medical Practice Act
162 (E) Chapter 70a Physician Assistant Act or
163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act
164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the
165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah
166 Optometry Practice Act
167 Section 4 Section 58-17b-3095 is amended to read
168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy
169 Division study of dispensing practitioners
170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen
171 (a) means a prescription drug used to treat cancer manage its symptoms or provide
172 continuity of care for a cancer patient
173 (b) includes
174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal
175 methods and
176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize
177 physical and psychological symptoms or pain or to improve patient tolerance of cancer
178 treatments or prepare a patient for a subsequent course of therapy and
179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug
180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections
181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt
182 from licensure under this chapter
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HB106 02-05-14 122 PM
214 (ii) is acting under the direction of a prescribing practitioner who is immediately
215 available on site for any necessary consultation and who has complied with Subsection
216 (2)(b)(i)
217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the
218 outpatient clinic setting and
219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)
220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to
221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section
222 (b) The evaluation under this Subsection (3) shall include
223 (i) practitioner compliance with the requirements of this section and Section
224 58-l7b-309
225 (ii) current research on dispensing and patient safety
226 (iii) survey of other state dispensing laws and
227 (iv) recommendations for future action concerning practitioner dispensing
228 (c) The division shall report to the Legislatures Health and Human Services Interim
229 Committee by November 302012 and by November 302013 with the results and
230 recommendations from the evaluation required by this Subsection (3)
231 (4) This section sunsets in accordance with Section 631-1-258
232 Section 5 Section 58-17b-3097 is enacted to read
233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an
234 employer sponsored clinic
235 (1) As used in this section
236 (a) Employer sponsored clinic means an entity that offers health care only to the
237 employees of an exclusive group of employers and the employees dependents
238 (b) Health care is as defined in Section 31 A-J-301
239 (c) Prepackaged drug means a prescription drug that
240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and
241 (ii) is packaged in a fixed quantity per package by
242 (A) the drug manufacturer
243 (B) a pharmaceutical wholesaler or distributor or
244 (C) a pharmacy licensed under this title
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~ -- -------------------
02-05-14 122 PM HB106
245 Cd) Prescribing practitioner is as defined in Section 58-17b-309
246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309
247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing
248 requirements of this chapter if the prescribing practitioner
249 Ca) treats an employee of one of an exclusive group of employers at an employer
250 sponsored clinic
251 Cb) prescribes a prepackaged drug to the employee
252 Cc) dispenses the prepackaged drug at the employer sponsored clinic
253 (d) notifies the division
254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the
255 employer sponsored clinic and
256 (ii) of the drug the prescribing practitioner intends to dispense
257 Ce) determines that providing the prepackaged drug to the employee at the employer
258 sponsored clinic is in the employees best interest
259 (f) informs the employee
260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner
261 from a pharmacy that is unaffiliated with the prescribing practitioner
262 (ii) of the directions for appropriate use of the prepackaged drug
263 (iii) of potential side effects to the use of the prepackaged drug and
264 (iv) how to contact the prescribing practitioner if the employee has questions or
265 concerns regarding the drug
266 (g) offers the employee the opportunity to consult with a pharmacist if the employee
267 asks for patient counseling and
268 (h) follows the administrative rules for a prescribing practitioner at an employer
269 sponsored clinic established by the division under Subsection (4)
270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a
271 prepackaged drug under this section requires physician supervision in its scope ofpractice
272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the
273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter
274 68 Utah Osteopathic Medical Practice Act
275 (4) The division shall in consultation with the board of pharmacy and the Physicians
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HBI06 02-05-14 122 PM
276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title
277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping
278 patient counseling purchasing and distribution operating treatment quality of care and
279 storage requirements for a prescribing practitioner at an employer sponsored clinic
280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a
281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing
282 practitioner is in compliance with this section
283 (6) If a prescribing practitioner violates a provision of this section the prescribing
284 practitioner may be subject to discipline under
285 (a) this chapter and
286 (b) any other chapter that governs the terms of the prescribing practitioners license
287 (7) The division shall evaluate the exemption created by this section and report to the
288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1
289 2018 on the results of the evaluation and the divisions recommendations regarding the
290 exemption
291 Section 6 Section 631-1-258 is amended to read
292 631-1-258 Repeal dates Title 58
293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is
294 repealed July 12016
295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015
296 (3) Section 58-17b-3095 is repealed July 1 2015
297 (4) Section 58-17b-3097 is repealed on July 12018
298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1
299 2018
300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1
301 2023
302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing
303 Act is repealed July 1 2019
304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1
305 2015
306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is
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02-05-14 1 22 PM HB106
307 repealed July 12023
308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1
309 2014
310 [ttej] ill) Section 58-69-3025 is repealed on July 12015
311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017
Legislative Review Note as of 2-3-14 418 PM
Office of Legislative Research and General Counsel
- 11 shy
State of Utah Department of Comnlerce Division of Occupational and Professional Licensing
GARY R HERBERT FRANCINEA GIANI MARK B STEINAGEL GOlernnr Executive Director DiviSIOn Director
GUIDELINES FOR HOSPITAL PHARMACIES and EMERGENCY DEPARTMENT TREATMENT
Approved by the Board of Pharmacy May 21 2012
The pharmacist is responsible for all pharmacy practice as del ineated under Utah Code 58-17b and 58-37fto include
bull ordering receiving and stocking bull filling drug carts drug rooms emergency drug stocks bull controlling inventory including audit trail [or each controlled substance bull maintaining and adhering to policies and protocols that maintain controls over controlled
substances (Utah Controlled Substances Act Subsection R156-37-502 defines unprofessional conduct to include (4) failing to maintain controls over controlled substances which would be considered by a prudent practitioner to be effective against diversion theft or shortage of controlled substances (5) being unable to account for shortages of controlled substances for any controlled substance inventory for which the licensee has responsibility)
bull reviewing Medication Proof of Use forms or logs returned to the pharmacist for purposes of review and reconciliation and
bull submitting all required controlled substance prescription information to the Controlled Substance Database pursuant to Utah Code 58-37f-203
NOTE Responsible means accountable for The pharmacist may delegate the task yet is ultimately accountable for the outcome Final checks of medications or medication profiles cannot be delegated
After-hours Medications Taken from Pharmacy When a Pharmacy is Closed
Only a pharmacist nurse supervisor or charge nurse can enter the pharmacy when the bull pharmacy is closed Medications can only be taken from the pharmacy on an emergency as needed basis Abull medication log must be used to keep a per medication inventory Only a pharmacist nurse supervisor or charge nurse can have access and the alarm code bull to whel1_~ltj)armacL~19~~~alth0lglil~one~~tthe p(irmacist can _~~___ ~ have a key to the locked controlled substance inventory in the pharmacy The pharmacy must still be equipped with a security system to permit detection of entry at all times when the facility is closed An adequate security system for inpatient phannacies within hospitals would be a system similar to a badge reader access which could uniquely store and retain which authorized person had made entry into the pharmacy after regular hours
wwwdoplulahgoYmiddot Heber M Wells Buildingmiddot 160 East300 South PO Box 146741 Salt Lake City UT 84114-6741 telephone (801) 530-6628 bull tollmiddot free in Utah (866) 275-3675 bull fax (801) 530-651 1 bull investigations fax (801) 530middot630 I UTAH
Dispensing of Drugs from an Emergency Room
bull Emergency room staff including the prescribing practitioner or Iicensed nurse cannot dispense prescriptions to a patient The prescribing practitioner can give an emergency supply which is properly labeled to a patient to get a patient started on the medication until a pharmacy is open This is not to be construed to allow a prescribing practitioner to give out an entire prescription amount
The related community standard for the treatment of typical Emergency Department conditions and STI prophylaxis is seven days
bull Such emergency doses of medications shall be labelcd with at least -Prescribing practitioners name and facility name and telephone number -Patients name -Name ormedication and strength -Number oftablets given -Date given and -I nstrLlctions for use
bull Records of controlled substances dispensed by the prescribing practitioner must be provided to the pharmacy so that applicable prescription data can be reported to the CSD
NOTE Physicians may give out samples which are clearly marked as a sample not for resale unti I the patient can get to a pharmacy or to try the medication for possible untoward effects Samples must be dispensed pursuant to Utah Code Annotated sect 58shy17b-610
Repackaging bull It is illegal for retail phannacies to repackage medications for resale to hospitals clinics
or other pharmacies The hospital pharmacy could legally repackage medications for use in its own institution
Federal Statute
According to Federal regulations repackaging requires a manufacturers license as stated in US Code 21-130001(27) and USC 21-1301lI(a)
USC 21-130001 reads Manufacture means the producing preparation propagation compounding or processing of a drug or other substance or the packaging or repackaging of such substance or the labeling or relabeling of the commercial container of such substance but
~----- middotmiddotmiddotmiddot_~aoesmmiddotnot IncluOelne-aCliiities omiddotf-a-praclilioifef-wlio~middotasan1nci(rentwhlS1hmiddoteraoffilnistratle)ffT5f-
dispensing such substance in the course of hisher professional practice prepares compounds packages or labels such substance
USC 21-130111 (a) reads Every person who manufactures distributes dispenses imports or exports any controlled substances or who proposes to engage in the manufacture distribution dispensing importation or exportation of any controlled substances shall obtain a registration
wwwdoptutahgovmiddot Heber M Wells Buildingmiddot 160 East 300 Southmiddot PO Box 146741 Salt Lake City UT 84114-6741 telephone (801) 530-6628middot toll-free in Utah (866) 275-3675 fax (801) 530-6511 investigations fax (801) 530-6301
LEGISLA TIVE GENERAL COUNSEL SB178 ct Approved for Filing Sc Allred ct
ct 02-05-14 1 56 PM ct
1 CONTROLLED SUBSTANCE DATABASE MODIFICATIONS
2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Evan J Vickers
5 House Sponsor Bradley G Last
6
7 LONG TITLE
8 General Description
9 This bill modifies the Controlled Substance Database Act regarding access by pharmacy
10 technicians
11 Highlighted Provisions
12 This bill
13 ~ allows the phannacist-in-charge to designate a licensed phannacy technician to have
14 access to the database on behalf of the phannacist in accordance with statutory
15 requirements
16 Money Appropriated in this Bill
17 None
18 Other Special Clauses
19 None
20 Utah Code Sections Affected
21 AMENDS
22 58-37fmiddot301 as last amended by Laws of Utah 2013 Chapters 12 130 and 262
23
24 Be it enacted by the Legislature ofthe state ofUtah
25
26
27
Section 1 Section 58-37fmiddot301 is amended to read
58-37fmiddot301 Access to database
(1) The division shall make rules in accordance with Title 63G Chapter 3 Utah
rJlbull =bull
1111111111111111111111111111111111111111
02-05-14 156 PM SB178
59 (A) fit within the responsibilities of the Department of Health for health and welfare
60 (B) are reviewed and approved by an Institutional Review Board that is approved for
61 human subject research by the United States Department of Health and Human Services and
62 (C) are not conducted for profit or commercial gain and
63 (D) are conducted in a research facility as defined by division rule that is associated
64 with a university or college in the state accredited by the Northwest Commission on Colleges
65 and Universities
66 (iii) the designee protects the information as a business associate of the Department of
67 Health and
68 (iv) the identity of the prescribers patients and pharmacies in the database are
69 de-identified confidential not disclosed in any manner to the designee or to any individual
70 who is not directly involved in the scientific studies
71 (e) a licensed practitioner having authority to prescribe controlled substances to the
72 extent the information
73 (i) (A) relates specifically to a current or prospective patient of the practitioner and
74 (B) is provided to or sought by the practitioner for the purpose of
75 (I) prescribing or considering prescribing any controlled substance to the current or
76 prospective patient
77 (II) diagnosing the current or prospective patient
78 (nn providing medical treatment or medical advice to the current or prospective
79 patient or
80 (IV) determining whether the current or prospective patient
81 (Aa) is attempting to fraudulently obtain a controlled substance from the practitioner
82 or
83 (Bb) has fraudulently obtained or attempted to fraudulently obtain a controlled
84 substance from the practitioner
85 (ii) (A) relates specifically to a fonner patient of the practitioner and
86 (B) is provided to or sought by the practitioner for the purpose of determining whether
87 the former patient has fraudulently obtained or has attempted to fraudulently obtain a
88 controlled substance from the practitioner
89 (iii) relates specifically to an individual who has access to the practitioners Drug
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02-05-14 156 PM SB178
121 58-3 7f-203(3 )(b) with respect to the employee
122 (h) a licensed pharmacist having authority to dispense a controlled substance to the
123 extent the information is provided or sought for the purpose of
124 (i) dispensing or considering dispensing any controlled substance or
125 (ii) determining whether a person
126 (A) is attempting to fraudulently obtain a controlled substance from the pharmacist or
127 (B) has fraudulently obtained or attempted to fraudulently obtain a controlled
128 substance from the pharmacist
129 (i) in accordance with Subsection (3)(a) a licensed pharmacy technician who is an
]30 employee of a pharmacy as defined in Section 58-17b-l 02 for the purposes described in
131 Subsection (2)(h)(i) or (iO if
132 0) the employee is designated by the pharmacist-in-charge as an individual authorized
133 to access the information on behalf of a licensed pharmacist employed by the pharmacy
134 (ii) the pharmacist-in-charge provides written notice to the division of the identity of
135 the employee and
136 (iii) the division
137 CA) grants the employee access to the database and
138 (B) provides the employee with a password that is unique to that employee to access
139 the database in order to permit the division to comply with the requirements of Subsection
140 58-37f-203(3)(b) with respect to the employee
141 [fiJ] ill federal state and local law enforcement authorities and state and local
142 prosecutors engaged as a specified duty of their employment in enforcing laws
143 (i) regulating controlled substances
144 (ii) investigating insurance fraud Medicaid fraud or Medicare fraud or
145 (iii) providing information about a criminal defendant to defense counsel upon request
146 during the discovery process for the purpose of establishing a defense in a criminal case
147 [61] fhl employees ofthe Office oflntemal Audit and Program Integrity within the
148 Department of Health who are engaged in their specified duty of ensuring Medicaid program
149 integrity under Section 26-18-23
150 [fki] ill a mental health therapist if
151 (i) the information relates to a patient who is
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02-05-14 156 PM SB178
183 designated under Subsection (2)(f) (2)(g) or (4)(c) should be granted access to the database
184 and
185 (ii) establish the information to be provided by an emergency room employee under
186 Subsection (4)
187 (c) The division shall grant an employee designated under Subsection (2)(f) (2)(g) or
188 (4)( c) access to the database unless the division determines based on a background check that
189 the employee poses a security risk to the information contained in the database
190 (4) (a) An individual who is employed in the emergency room ofa hospital may
191 exercise access to the database under this Subsection (4) on behalf of a licensed practitioner if
192 the individual is designated under Subsection (4)( c) and the licensed practitioner
193 (i) is employed in the emergency room
194 Oi) is treating an emergency room patient for an emergency medical condition and
195 (iii) requests that an individual employed in the emergency room and designated under
196 Subsection (4)( c) obtain information regarding the patient from the database as needed in the
197 course of treatment
198 (b) The emergency room employee obtaining information from the database shall
199 when gaining access to the database provide to the database the name and any additional
200 identifiers regarding the requesting practitioner as required by division administrative rule
201 established under Subsection (3)(b)
202 (c) An individual employed in the emergency room under this Subsection (4) may
203 obtain information from the database as provided in Subsection (4)(a) if
204 (i) the employee is designated by the practitioner as an individual authorized to access
205 the information on behalf of the practitioner
206 (ii) the practitioner and the hospital operating the emergency room provide written
207 notice to the division of the identity of the designated employee and
208 (iii) the division
209 (A) grants the employee access to the database and
210 (B) provides the employee with a password that is unique to that employee to access
211 the database in order to permit the division to comply with the requirements of Subsection
212 58-37f-203(3)(b) with respect to the employee
213 (d) The division may impose a fee in accordance with Section 63J-I-504 on a
- 7
LEGISLATIVE GENERAL C01JNSEL SB55 iL Approved for Filing Cl Dupont iL lst Sub (Green)
iL 02-07-14 416 PM iL
Senator Evan J Vickers proposes the following substitute bill
PHARMACEUTICAL DISPENSING AMENDMENTS
2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Evan J Vickers
5 House Sponsor Stewart Barlow
6
7 LONG TITLE
8 General Description
9 This bill amends the Pharmacy Practice Act to create a dispensing medical practitioner
10 license and a license classification for a dispensing medical practitioner clinic
11 pharmacy
12 Highlighted Provisions
13 This bill
14 defines terms
15 establishes the license classification dispensing medical practitioner under the
16 Pharmacy Practice Act for medical practitioners who prescribe and dispense a drug
17 establishes the pharmacy facility license classification dispensing medical
18 practitioner clinic pharmacy under the Pharmacy Practice Act
19 creates Part 8 Dispensing Medical Practitioner and Dispensing Medical Practitioner
20 Clinic Pharmacy
21 removes the exemption from the Pharmacy Practice Act for medical practitioners
22 who prescribe and dispense a cosmetic drug injectable weight loss drug or a cancer
23 drug treatment regimen
24 requires a license as a dispensing medical practitioner for a health care practitioner 00
25 to dispense bull bull=
1111111111111111111111111111111111111111111111111111111
02-07-14 416 PM 1st Sub (Green) SB 55
615 Practitioner Clinic Pharmacy II
616 Section 8 Section 58-17b-802 is enacted to read
617 58-17b-802 Definitions
618 As used in this part
619 (1) (a) Cosmetic drug means a prescription drug that
620 (i) is for the purpose of promoting attractiveness or altering the appearance of an
621 individual and
622 (ii) (A) is listed as a cosmetic drug subject to the exemption under this section by the
623 division by administrative rule or
624 CB) has been expressly approved for online dispensing whether or not it is dispensed
625 online or through a physicians office
626 (b) Cosmetic drug does not include a prescription drug that is
627 (i) a controlled substance
628 (ii) compounded by the physician or
629 (iii) prescribed or used for the patient for the purpose of diagnosing curing or
630 preventing a disease
631 (2) Employer sponsored clinic means an entity that S-t has a medical director who is
631 a licensed as a physician as defined in Section 58-67-102 and S offers health care only to the
632 employees of an exclusive group of employers and the employees dependents
633 (3) Health care is as defined in Section 31A-1-301
634 (4) Ca) Injectable weight loss drug means an injectable prescription drug
635 (n prescribed to promote weight loss and
636 (ii) listed as an injectable prescription drug subject to exemption under this section by
637 the division by administrative rule
638 (b) Injectable weight loss drug does not include a prescription drug that is a
639 controlled substance
640 (5) Prepackaged drug means a prescription drug that
641 (a) is not listed under federal or state law as a Schedule I II ill IV or V drug and
642 (b) is packaged in a fixed quantity per package by
643 (i) the drug manufacturer
644 (ii) a pharmaceutical wholesaler or distributor or
645 (iii) a pharmacy licensed under this title
- 21 Senate Committee Amendments 2-13-2014 Jplcjd
1st Sub (Green) SB 55 02-07-14 416 PM
646 Section 9 Section 58-17b-803 is enacted to read
647 58-17b-803 Qualifications for licensure as a dispensing medical practitioner -shy
648 Scope of practice
649 (1) An applicant for a license as a dispensing medical practitioner shall
650 (a) be licensed in good standing under at least one of the chapters listed in Subsection
651 58-17b-l02(23)(a) and
652 (b) submit an application for a license as a dispensing medical practitioner in a form
653 prescribed by the division and pay a fee established by the S [depal tment] divisionS ~
654 (2) The division shall accept the licensing in good standing under Subsection (1) in lieu
655 of requiring an applicant for a license under this part to comply with Sections 58-17b-303 and
656
657 (3) A dispensing medical practitioner may dispense in accordance with this part
658 (a) a cosmetic drug and an injectable weight loss drug if
659 (i) the drug was prescribed by the dispensing medical practitioner to the dispensing
660 medical practitioners patient and
661 Oi) the dispensing medical practitioner complies with administrative rules adopted by
662 the division under Subsection 58-17-802(1)
663 (b) a cancer drug treatment regimen if the dispensing medical practitioner complies
664 with Section 58-17b-805 and
665 (c) a pre-packaged drug to an employee or a dependent of an employee at an employer
666 sponsored clinic if the dispensing medical practitioner
667 (i) treats an employee or the dependent of an employee of one of an exclusive group
668 of employers at an employer sponsored clinic
669 (ii) prescribes a prepackaged drug to the employee or the employees dependent
670 (iii) dispenses the prepackaged drug at the employer sponsored clinic and
671 (iv) complies with administrative rules adopted by the division in consultation with the
672 Board of Pharmacy that establish labeling record keeping patient counseling purchasing and
673 distribution operating treatment quality of care and storage requirements
674 (4) A dispensing medical practitioner
675 Ca) shall inform the patient
676 (i) that the drug dispensed by the practitioner may be obtained from a pharmacy
- 22 - Senate Committee Amendments 2-13-2014 picjd
02-07-14 416 PM 1st Sub (Green) SB 55
739 58-17b-806 Dispensing medical practitioner -- Dispensing medical practitioner
740 clinic pharmacy -- Unprofessional and Unlawful conduct
741 ill S Ull S The division S [ iii consultation witb tile boal d shall
742 (a) I epol t a violation of this chapter b a dispensing medical pi actitiollel to] shall consult
742a with S the
743 dispensing medical practitioners appropriate licensing board as designated in Subsection
744 5S-17b-l02(23)(a) S reeardine a violation oftMs chapterS and
745 (hl S the Pharmacy Board shall if requested by the licensine board of the dispensine
745a medical practitionerS assist the licensing board for the dispensing medical practitioner with
745b reviewing the
746 violations of the provisions of this chapter
747 (2) The division S [ in collabOi atioll with the Boal d ofPhall1l3C]S may take
747a appropriate
748 action against a dispensing medical practitioner in accordance with this chapter if the
749 licensing board designated in Subsection 58-17b- 02(23)(a) recommends to the division that
750 action be taken under this chapter
751 (3) The division in consultation with the board is the primary enforcer under this
752 chapter for a dispensing medical practitioner clinic pharmacy licensed under Section
753 58-17b-804
754 Section 13 Section 58-31b-502 is amended to read
755 58-31b-502 Unprofessional conduct
756 Unprofessional conduct includes
757 (l) failure to safeguard a patients right to privacy as to the patients person condition
758 diagnosis personal effects or any other matter about which the licensee is privileged to know
759 because of the licensees or person with a certifications position or practice as a nurse or
760 practice as a medication aide certified
761 (2) failure to provide nursing service or service as a medication aide certified in a
762 manner that demonstrates respect for the patients human dignity and unique personal character
763 and needs without regard to the patients race religion ethnic background socioeconomic
764 status age sex or the nature of the patients health problem
765 (3) engaging in sexual relations with a patient during any
766 (a) period when a generally recognized professional relationship exists between the
767 person licensed or certified under this chapter and patient or
768 (b) extended period when a patient has reasonable cause to believe a professional
769 relationship exists between the person licensed or certified under the provisions of this chapter
- 25 - Senate Committee Amendments 2-13-2014Iplcjd
LEGISLA TIVE GENERAL COUNSEL SB138 ct Approved for Filing Sc Allred ct
ct 02-04-14 1220 PM ct
1 CONTROLLED SUBSTANCES ACT AMENDMENTS
2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Evan J Vickers
5 House Sponsor Stewart Barlow
6
7 LONG TITLE
8 General Description
9 This bill modifies the Utah Controlled Substances Act regarding prescriptions for
10 controlled substances
11 Highlighted Provisions
12 This bill
13 ~ provides that more than one controlled substance may be included in a prescription
14 Money Appropriated in this Bill
15 None
16 Other Special Clauses
17 None
18 Utah Code Sections Affected
19 AMENDS
20 58-37-6 as last amended by Laws of Utah 2012 Chapter 272
21
22 Be it enacted by the Legislature of the state ofUtah
23 Section 1 Section 58-37-6 is amended to read
24 58-37-6 License to manufacture produce distribute dispense administer or
25 conduct research -- Issuance by division -- Denial suspension or revocation -- Records
26
27
required -- Prescriptions
(1) (a) The division may adopt rules relating to the licensing and control of the bull
1111111111111111111111111111111111111111
SB138 02-04-14 1220 PM
214 (ii) the prescribed controlled substance is to be used in research
215 (f) Except when administered directly to an ultimate user by a licensed practitioner
216 controlled substances are subject to the following restrictions
217 (i) (A) A prescription for a Schedule IT substance may not be refilled
218 (B) A Schedule II controlled substance may not be filled in a quantity to exceed a
219 one-months supply as directed on the daily dosage rate of the prescriptions
220 (ii) A Schedule ill or IV controlled substance may be filled only within six months of
221 issuance and may not be refilled more than six months after the date of its original issuance or
222 be refilled more than five times after the date of the prescription unless renewed by the
223 practitioner
224 (iii) All other controlled substances in Schedule V may be refilled as the prescribers
225 prescription directs but they may not be refilled one year after the date the prescription was
226 issued unless renewed by the practitioner
227 (iv) Any prescription for a Schedule IT substance may not be dispensed if it is not
228 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days
229 after the date the prescription was issued or 30 days after the dispensing date if that date is
230 specified separately from the date of issue
231 (v) A practitioner may issue more than one prescription at the same time for the same
232 Schedule IT controlled substance but only under the following conditions
233 (A) no more than three prescriptions for the same Schedule IT controlled substance may
234 be issued at the same time
235 (B) no one prescription may exceed a 30-day supply
236 (C) a second or third prescription shall include the date of issuance and the date for
237 dispensing and
238 (D) unless the practitioner determines there is a valid medical reason to the contrary
239 the date for dispensing a second or third prescription may not be fewer than 30 days from the
240 dispensing date of the previous prescription
241 [(1i) Each prescription rot a controlled snbstance may eontain only one controlled
242 substance per pIescription frlim and may not contain any other legend dmg 01 prescription
243 item]
244 (g) An order for a controlled substance in Schedules IT through V for use by an
- 8 shy
LEGISLATIVE GENERAL COUNSEL it Approved for Filing CJ Dupont it
HB114
it 02-06-14855 AM it
1 MAIL-ORDER WHOLESALE DRUG AMENDMENTS 2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Stewart Barlow
5 Senate Sponsor ______
6
7 LONG TITLE
8 General Description
9 This bill amends the Pharmacy Practice Act
10 Highlighted Provisions
11 This bill
12 ~ amends the definition of a class C pharmacy subject to regulation under the
13 Pharmacy Practice Act
14 Money Appropriated in this Bill
15 None
16 Other Special Clauses
17 This bi II takes effect on July 1 2014
18 Utah Code Sections Affected
19 AMENDS
20 58-17b-102 as last amended by Laws of Utah 2013 Chapters 52 166 and 423
21
22 Be it enacted by the Legislature ofthe state ofUtah
23 Section 1 Section 58-17b-102 is amended to read
24 58-17b-102 Definitions
25 In addition to the definitions in Section 58-1-102 as used in this chapter
26
27
(1) Administering means
(a) the direct application of a prescription drug or device whether by injection
==bull =bull
1111111111111111111111111111111111111111
02-06-14855 AM HB114
59 (9) Centralized prescription processing means the processing by a pharmacy of a
60 request from another pharmacy to fill or refill a prescription drug order or to perform
61 processing functions such as dispensing drug utilization review claims adjudication refill
62 authorizations and therapeutic interventions
63 (10) Class A pharmacy means a pharmacy located in Utah that is authorized as a
64 retail pharmacy to compound or dispense a drug or dispense a device to the public under a
65 prescription order
66 (11) Class B pharmacy
67 (a) means a pharmacy located in Utah
68 (i) that is authorized to provide pharmaceutical care for patients in an institutional
69 setting and
70 (ii) whose primary purpose is to provide a physical environment for patients to obtain
71 health care services and
72 (b) (i) includes closed-door hospital clinic nuclear and branch pharmacies and
73 (ii) pharmaceutical administration and sterile product preparation facilities
74 (12) Class C pharmacy means a pharmacy [located ill Utah that is anthOl ized to
75 engage] that engages in the manufacture production wholesale or distribution of drugs or
76 devices in Utah
77 (13) Class D pharmacy means a nonresident pharmacy
78 (14) Class E pharmacy means all other pharmacies
79 (15) Closed-door pharmacy means a pharmacy that provides pharmaceutical care to a
80 defined and exclusive group of patients who have access to the services of the pharmacy
81 because they are treated by or have an affiliation with a specific entity including a health
82 maintenance organization or an infusion company but not including a hospital pharmacy a
83 retailer of goods to the general public or the office of a practitioner
84 (16) Collaborative pharmacy practice means a practice of pharmacy whereby one or
85 more pharmacists have jointly agreed on a voluntary basis to work in conjunction with one or
86 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical
87 care functions authorized by the practitioner or practitioners under certain specified conditions
88 or limitations
89 (17) Collaborative pharmacy practice agreement means a written and signed
- 3 shy
02-06-14855 AM HB114
369 and
370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in
371 collaboration with the board
372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501
373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and
374 may be further defined by rule
375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that
376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration
377 for animals
378 Section 2 Effective date
379 This bill takes effect on July I 2014
Legislative Review Note as of 2-4-14 1243 PM
Office of Legislative Research and General Counsel
- 13 shy
LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t
t 02-05-14 122PM t
1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG
2 AMENDMENTS
3 2014 GENERAL SESSION
4 STATE OF UTAH
5 Chief Sponsor Stewart Barlow
6 Senate Sponsor
7
8 LONG TITLE
9 General Description
10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from
11 its licensing requirements under certain circumstances
12 Highlighted Provisions
13 This bill
14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy
15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an
16 employer sponsored clinic and complies with other requirements
17 repeals subject to sunset review the provisions of this bill relating to the exemption
18 described above and
19 ~ makes technical and conforming changes
20 Money Appropriated in this Bill
21 None
22 Other Special Clauses
23 None
24 Utah Code Sections Affected
25 AMENDS
26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~
27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull
1111111111111111111111111111111111111111
HBI06 02-05-14 122 PM
28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278
29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234
30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351
31 ENACTS
32 58-17b-3097 Utah Code Annotated 1953
33
34 Be it enacted by the Legislature ofthe state ofUtah
35 Section 1 Section 58-17b-301 is amended to read
36 58-17b-301 License required -- License classifications for individuals
37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the
38 practice of a pharmacy technician except as specifically provided in Section 58-1-307
39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097
40 (2) The division shall issue to an individual who qualifies under this chapter a license
41 in the classification of
42 (a) pharmacist
43 (b) pharmacy intern or
44 (c) pharmacy technician
45 Section 2 Section 58-17b-302 is amended to read
46 58-17b-302 License required -- License classifications for pharmacy facilities
47 (l) A license is required to act as a pharmacy except as specifically exempted from
48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or
49
50 (2) The division shall issue a pharmacy license to a facility that qualifies under this
51 chapter in the classification of a
52 (a) class A pharmacy
53 (b) class B pharmacy
54 (c) class C pharmacy
55 (d) class D pharmacy or
56 (e) class E pharmacy
57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist
58 at the same address a separate license shall be required for each pharmacy
-2shy
02-05-14 122 PM HBI06
59 (4) The division may further define or supplement the classifications of pharmacies
60 The division may impose restrictions upon classifications to protect the public health safety
61 and welfare
62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by
63 rule
64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy
65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities
66 of the pharmacy regardless of the form of the business organization
67 Section 3 Section 58-17b-309 is amended to read
68 58-17b-309 Exemptions from licensure
69 (l) [For ptnp05C5 of] As used in this section
70 (a) Cosmetic drug
71 (i) means a prescription drug that is
72 (A) for the purpose of promoting attractiveness or altering the appearance of an
73 individual and
74 (8) listed as a cosmetic drug subject to the exemption under this section by the division
75 by administrative rule or has been expressly approved for online dispensing whether or not it is
76 dispensed online or through a physicians office and
77 (ii) does not include a prescription drug that is
78 (A) a controlled substance
79 (8) compounded by the physician or
80 (C) prescribed or used for the patient for the purpose of diagnosing curing or
81 preventing a disease
82 (b) Injectable weight loss drug
83 (i) means an injectable prescription drug
84 (A) prescribed to promote weight loss and
85 (8) listed as an injectable prescription drug subject to exemption under this section by
86 the division by administrative rule and
87 (ii) does not include a prescription drug that is a controlled substance
88 (c) Prescribing practitioner means an individual licensed under
89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with
- 3 shy
HB106 02-05-14 122 PM
90 prescriptive practice
91 (ii) Chapter 67 Utah Medical Practice Act
92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or
93 (iv) Chapter 70a Physician Assistant Act
94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l
95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the
96 acts or practices described in this section without being licensed under this chapter
97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the
98 individual notifies the division in writing of the individuals intent to dispense a drug under this
99 [snbsectioll] Subsection (2)
100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1
101 (c) an individual engaging in the practice of pharmacy technician under the direct
102 personal supervision of a pharmacist while making satisfactory progress in an approved
103 program as defined in division rule
104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an
105 injectable weight loss drug to the prescribing practitioners patient in accordance with
106 Subsection (4) or
107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists
108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic
109 drug to the optometrists patient in accordance with Subsection (4)
110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under
111 Subsection (2)( c) must take all examinations as required by division rule following completion
112 of an approved curriculum of education within the required time frame This exemption
113 expires immediately upon notification of a failing score of an examination and the individual
114 may not continue working as a pharmacy technician even under direct supervision
115 (4) A prescribing practitioner or optometrist is exempt from licensing under the
116 provisions of this part if the prescribing practitioner or optometrist
117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the
118 authority to dispense under Subsection (4)(b) and
119 (ii) informs the patient
120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing
-4shy
HB106 02-05-14 122 PM
152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the
153 prescribing practitioners or optometrists office and determine if the provisions of this section
154 are being met by the prescribing practitioner or optometrist
155 (d) If a prescribing practitioner or optometrist violates a provision of this section the
156 prescribing practitioner or optometrist may be subject to discipline under
157 (i) this chapter and
158 (ii) (A) Chapter 16a Utah Optometry Practice Act
159 (B) Chapter 31 b Nurse Practice Act
160 (C) Chapter 67 Utah Medical Practice Act
161 (D) Chapter 68 Utah Osteopathic Medical Practice Act
162 (E) Chapter 70a Physician Assistant Act or
163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act
164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the
165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah
166 Optometry Practice Act
167 Section 4 Section 58-17b-3095 is amended to read
168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy
169 Division study of dispensing practitioners
170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen
171 (a) means a prescription drug used to treat cancer manage its symptoms or provide
172 continuity of care for a cancer patient
173 (b) includes
174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal
175 methods and
176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize
177 physical and psychological symptoms or pain or to improve patient tolerance of cancer
178 treatments or prepare a patient for a subsequent course of therapy and
179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug
180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections
181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt
182 from licensure under this chapter
- 6shy
HB106 02-05-14 122 PM
214 (ii) is acting under the direction of a prescribing practitioner who is immediately
215 available on site for any necessary consultation and who has complied with Subsection
216 (2)(b)(i)
217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the
218 outpatient clinic setting and
219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)
220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to
221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section
222 (b) The evaluation under this Subsection (3) shall include
223 (i) practitioner compliance with the requirements of this section and Section
224 58-l7b-309
225 (ii) current research on dispensing and patient safety
226 (iii) survey of other state dispensing laws and
227 (iv) recommendations for future action concerning practitioner dispensing
228 (c) The division shall report to the Legislatures Health and Human Services Interim
229 Committee by November 302012 and by November 302013 with the results and
230 recommendations from the evaluation required by this Subsection (3)
231 (4) This section sunsets in accordance with Section 631-1-258
232 Section 5 Section 58-17b-3097 is enacted to read
233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an
234 employer sponsored clinic
235 (1) As used in this section
236 (a) Employer sponsored clinic means an entity that offers health care only to the
237 employees of an exclusive group of employers and the employees dependents
238 (b) Health care is as defined in Section 31 A-J-301
239 (c) Prepackaged drug means a prescription drug that
240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and
241 (ii) is packaged in a fixed quantity per package by
242 (A) the drug manufacturer
243 (B) a pharmaceutical wholesaler or distributor or
244 (C) a pharmacy licensed under this title
- 8 shy
~ -- -------------------
02-05-14 122 PM HB106
245 Cd) Prescribing practitioner is as defined in Section 58-17b-309
246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309
247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing
248 requirements of this chapter if the prescribing practitioner
249 Ca) treats an employee of one of an exclusive group of employers at an employer
250 sponsored clinic
251 Cb) prescribes a prepackaged drug to the employee
252 Cc) dispenses the prepackaged drug at the employer sponsored clinic
253 (d) notifies the division
254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the
255 employer sponsored clinic and
256 (ii) of the drug the prescribing practitioner intends to dispense
257 Ce) determines that providing the prepackaged drug to the employee at the employer
258 sponsored clinic is in the employees best interest
259 (f) informs the employee
260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner
261 from a pharmacy that is unaffiliated with the prescribing practitioner
262 (ii) of the directions for appropriate use of the prepackaged drug
263 (iii) of potential side effects to the use of the prepackaged drug and
264 (iv) how to contact the prescribing practitioner if the employee has questions or
265 concerns regarding the drug
266 (g) offers the employee the opportunity to consult with a pharmacist if the employee
267 asks for patient counseling and
268 (h) follows the administrative rules for a prescribing practitioner at an employer
269 sponsored clinic established by the division under Subsection (4)
270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a
271 prepackaged drug under this section requires physician supervision in its scope ofpractice
272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the
273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter
274 68 Utah Osteopathic Medical Practice Act
275 (4) The division shall in consultation with the board of pharmacy and the Physicians
- 9 shy
HBI06 02-05-14 122 PM
276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title
277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping
278 patient counseling purchasing and distribution operating treatment quality of care and
279 storage requirements for a prescribing practitioner at an employer sponsored clinic
280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a
281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing
282 practitioner is in compliance with this section
283 (6) If a prescribing practitioner violates a provision of this section the prescribing
284 practitioner may be subject to discipline under
285 (a) this chapter and
286 (b) any other chapter that governs the terms of the prescribing practitioners license
287 (7) The division shall evaluate the exemption created by this section and report to the
288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1
289 2018 on the results of the evaluation and the divisions recommendations regarding the
290 exemption
291 Section 6 Section 631-1-258 is amended to read
292 631-1-258 Repeal dates Title 58
293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is
294 repealed July 12016
295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015
296 (3) Section 58-17b-3095 is repealed July 1 2015
297 (4) Section 58-17b-3097 is repealed on July 12018
298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1
299 2018
300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1
301 2023
302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing
303 Act is repealed July 1 2019
304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1
305 2015
306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is
- 10shy
02-05-14 1 22 PM HB106
307 repealed July 12023
308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1
309 2014
310 [ttej] ill) Section 58-69-3025 is repealed on July 12015
311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017
Legislative Review Note as of 2-3-14 418 PM
Office of Legislative Research and General Counsel
- 11 shy
Dispensing of Drugs from an Emergency Room
bull Emergency room staff including the prescribing practitioner or Iicensed nurse cannot dispense prescriptions to a patient The prescribing practitioner can give an emergency supply which is properly labeled to a patient to get a patient started on the medication until a pharmacy is open This is not to be construed to allow a prescribing practitioner to give out an entire prescription amount
The related community standard for the treatment of typical Emergency Department conditions and STI prophylaxis is seven days
bull Such emergency doses of medications shall be labelcd with at least -Prescribing practitioners name and facility name and telephone number -Patients name -Name ormedication and strength -Number oftablets given -Date given and -I nstrLlctions for use
bull Records of controlled substances dispensed by the prescribing practitioner must be provided to the pharmacy so that applicable prescription data can be reported to the CSD
NOTE Physicians may give out samples which are clearly marked as a sample not for resale unti I the patient can get to a pharmacy or to try the medication for possible untoward effects Samples must be dispensed pursuant to Utah Code Annotated sect 58shy17b-610
Repackaging bull It is illegal for retail phannacies to repackage medications for resale to hospitals clinics
or other pharmacies The hospital pharmacy could legally repackage medications for use in its own institution
Federal Statute
According to Federal regulations repackaging requires a manufacturers license as stated in US Code 21-130001(27) and USC 21-1301lI(a)
USC 21-130001 reads Manufacture means the producing preparation propagation compounding or processing of a drug or other substance or the packaging or repackaging of such substance or the labeling or relabeling of the commercial container of such substance but
~----- middotmiddotmiddotmiddot_~aoesmmiddotnot IncluOelne-aCliiities omiddotf-a-praclilioifef-wlio~middotasan1nci(rentwhlS1hmiddoteraoffilnistratle)ffT5f-
dispensing such substance in the course of hisher professional practice prepares compounds packages or labels such substance
USC 21-130111 (a) reads Every person who manufactures distributes dispenses imports or exports any controlled substances or who proposes to engage in the manufacture distribution dispensing importation or exportation of any controlled substances shall obtain a registration
wwwdoptutahgovmiddot Heber M Wells Buildingmiddot 160 East 300 Southmiddot PO Box 146741 Salt Lake City UT 84114-6741 telephone (801) 530-6628middot toll-free in Utah (866) 275-3675 fax (801) 530-6511 investigations fax (801) 530-6301
LEGISLA TIVE GENERAL COUNSEL SB178 ct Approved for Filing Sc Allred ct
ct 02-05-14 1 56 PM ct
1 CONTROLLED SUBSTANCE DATABASE MODIFICATIONS
2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Evan J Vickers
5 House Sponsor Bradley G Last
6
7 LONG TITLE
8 General Description
9 This bill modifies the Controlled Substance Database Act regarding access by pharmacy
10 technicians
11 Highlighted Provisions
12 This bill
13 ~ allows the phannacist-in-charge to designate a licensed phannacy technician to have
14 access to the database on behalf of the phannacist in accordance with statutory
15 requirements
16 Money Appropriated in this Bill
17 None
18 Other Special Clauses
19 None
20 Utah Code Sections Affected
21 AMENDS
22 58-37fmiddot301 as last amended by Laws of Utah 2013 Chapters 12 130 and 262
23
24 Be it enacted by the Legislature ofthe state ofUtah
25
26
27
Section 1 Section 58-37fmiddot301 is amended to read
58-37fmiddot301 Access to database
(1) The division shall make rules in accordance with Title 63G Chapter 3 Utah
rJlbull =bull
1111111111111111111111111111111111111111
02-05-14 156 PM SB178
59 (A) fit within the responsibilities of the Department of Health for health and welfare
60 (B) are reviewed and approved by an Institutional Review Board that is approved for
61 human subject research by the United States Department of Health and Human Services and
62 (C) are not conducted for profit or commercial gain and
63 (D) are conducted in a research facility as defined by division rule that is associated
64 with a university or college in the state accredited by the Northwest Commission on Colleges
65 and Universities
66 (iii) the designee protects the information as a business associate of the Department of
67 Health and
68 (iv) the identity of the prescribers patients and pharmacies in the database are
69 de-identified confidential not disclosed in any manner to the designee or to any individual
70 who is not directly involved in the scientific studies
71 (e) a licensed practitioner having authority to prescribe controlled substances to the
72 extent the information
73 (i) (A) relates specifically to a current or prospective patient of the practitioner and
74 (B) is provided to or sought by the practitioner for the purpose of
75 (I) prescribing or considering prescribing any controlled substance to the current or
76 prospective patient
77 (II) diagnosing the current or prospective patient
78 (nn providing medical treatment or medical advice to the current or prospective
79 patient or
80 (IV) determining whether the current or prospective patient
81 (Aa) is attempting to fraudulently obtain a controlled substance from the practitioner
82 or
83 (Bb) has fraudulently obtained or attempted to fraudulently obtain a controlled
84 substance from the practitioner
85 (ii) (A) relates specifically to a fonner patient of the practitioner and
86 (B) is provided to or sought by the practitioner for the purpose of determining whether
87 the former patient has fraudulently obtained or has attempted to fraudulently obtain a
88 controlled substance from the practitioner
89 (iii) relates specifically to an individual who has access to the practitioners Drug
- 3 shy
02-05-14 156 PM SB178
121 58-3 7f-203(3 )(b) with respect to the employee
122 (h) a licensed pharmacist having authority to dispense a controlled substance to the
123 extent the information is provided or sought for the purpose of
124 (i) dispensing or considering dispensing any controlled substance or
125 (ii) determining whether a person
126 (A) is attempting to fraudulently obtain a controlled substance from the pharmacist or
127 (B) has fraudulently obtained or attempted to fraudulently obtain a controlled
128 substance from the pharmacist
129 (i) in accordance with Subsection (3)(a) a licensed pharmacy technician who is an
]30 employee of a pharmacy as defined in Section 58-17b-l 02 for the purposes described in
131 Subsection (2)(h)(i) or (iO if
132 0) the employee is designated by the pharmacist-in-charge as an individual authorized
133 to access the information on behalf of a licensed pharmacist employed by the pharmacy
134 (ii) the pharmacist-in-charge provides written notice to the division of the identity of
135 the employee and
136 (iii) the division
137 CA) grants the employee access to the database and
138 (B) provides the employee with a password that is unique to that employee to access
139 the database in order to permit the division to comply with the requirements of Subsection
140 58-37f-203(3)(b) with respect to the employee
141 [fiJ] ill federal state and local law enforcement authorities and state and local
142 prosecutors engaged as a specified duty of their employment in enforcing laws
143 (i) regulating controlled substances
144 (ii) investigating insurance fraud Medicaid fraud or Medicare fraud or
145 (iii) providing information about a criminal defendant to defense counsel upon request
146 during the discovery process for the purpose of establishing a defense in a criminal case
147 [61] fhl employees ofthe Office oflntemal Audit and Program Integrity within the
148 Department of Health who are engaged in their specified duty of ensuring Medicaid program
149 integrity under Section 26-18-23
150 [fki] ill a mental health therapist if
151 (i) the information relates to a patient who is
- 5 shy
02-05-14 156 PM SB178
183 designated under Subsection (2)(f) (2)(g) or (4)(c) should be granted access to the database
184 and
185 (ii) establish the information to be provided by an emergency room employee under
186 Subsection (4)
187 (c) The division shall grant an employee designated under Subsection (2)(f) (2)(g) or
188 (4)( c) access to the database unless the division determines based on a background check that
189 the employee poses a security risk to the information contained in the database
190 (4) (a) An individual who is employed in the emergency room ofa hospital may
191 exercise access to the database under this Subsection (4) on behalf of a licensed practitioner if
192 the individual is designated under Subsection (4)( c) and the licensed practitioner
193 (i) is employed in the emergency room
194 Oi) is treating an emergency room patient for an emergency medical condition and
195 (iii) requests that an individual employed in the emergency room and designated under
196 Subsection (4)( c) obtain information regarding the patient from the database as needed in the
197 course of treatment
198 (b) The emergency room employee obtaining information from the database shall
199 when gaining access to the database provide to the database the name and any additional
200 identifiers regarding the requesting practitioner as required by division administrative rule
201 established under Subsection (3)(b)
202 (c) An individual employed in the emergency room under this Subsection (4) may
203 obtain information from the database as provided in Subsection (4)(a) if
204 (i) the employee is designated by the practitioner as an individual authorized to access
205 the information on behalf of the practitioner
206 (ii) the practitioner and the hospital operating the emergency room provide written
207 notice to the division of the identity of the designated employee and
208 (iii) the division
209 (A) grants the employee access to the database and
210 (B) provides the employee with a password that is unique to that employee to access
211 the database in order to permit the division to comply with the requirements of Subsection
212 58-37f-203(3)(b) with respect to the employee
213 (d) The division may impose a fee in accordance with Section 63J-I-504 on a
- 7
LEGISLATIVE GENERAL C01JNSEL SB55 iL Approved for Filing Cl Dupont iL lst Sub (Green)
iL 02-07-14 416 PM iL
Senator Evan J Vickers proposes the following substitute bill
PHARMACEUTICAL DISPENSING AMENDMENTS
2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Evan J Vickers
5 House Sponsor Stewart Barlow
6
7 LONG TITLE
8 General Description
9 This bill amends the Pharmacy Practice Act to create a dispensing medical practitioner
10 license and a license classification for a dispensing medical practitioner clinic
11 pharmacy
12 Highlighted Provisions
13 This bill
14 defines terms
15 establishes the license classification dispensing medical practitioner under the
16 Pharmacy Practice Act for medical practitioners who prescribe and dispense a drug
17 establishes the pharmacy facility license classification dispensing medical
18 practitioner clinic pharmacy under the Pharmacy Practice Act
19 creates Part 8 Dispensing Medical Practitioner and Dispensing Medical Practitioner
20 Clinic Pharmacy
21 removes the exemption from the Pharmacy Practice Act for medical practitioners
22 who prescribe and dispense a cosmetic drug injectable weight loss drug or a cancer
23 drug treatment regimen
24 requires a license as a dispensing medical practitioner for a health care practitioner 00
25 to dispense bull bull=
1111111111111111111111111111111111111111111111111111111
02-07-14 416 PM 1st Sub (Green) SB 55
615 Practitioner Clinic Pharmacy II
616 Section 8 Section 58-17b-802 is enacted to read
617 58-17b-802 Definitions
618 As used in this part
619 (1) (a) Cosmetic drug means a prescription drug that
620 (i) is for the purpose of promoting attractiveness or altering the appearance of an
621 individual and
622 (ii) (A) is listed as a cosmetic drug subject to the exemption under this section by the
623 division by administrative rule or
624 CB) has been expressly approved for online dispensing whether or not it is dispensed
625 online or through a physicians office
626 (b) Cosmetic drug does not include a prescription drug that is
627 (i) a controlled substance
628 (ii) compounded by the physician or
629 (iii) prescribed or used for the patient for the purpose of diagnosing curing or
630 preventing a disease
631 (2) Employer sponsored clinic means an entity that S-t has a medical director who is
631 a licensed as a physician as defined in Section 58-67-102 and S offers health care only to the
632 employees of an exclusive group of employers and the employees dependents
633 (3) Health care is as defined in Section 31A-1-301
634 (4) Ca) Injectable weight loss drug means an injectable prescription drug
635 (n prescribed to promote weight loss and
636 (ii) listed as an injectable prescription drug subject to exemption under this section by
637 the division by administrative rule
638 (b) Injectable weight loss drug does not include a prescription drug that is a
639 controlled substance
640 (5) Prepackaged drug means a prescription drug that
641 (a) is not listed under federal or state law as a Schedule I II ill IV or V drug and
642 (b) is packaged in a fixed quantity per package by
643 (i) the drug manufacturer
644 (ii) a pharmaceutical wholesaler or distributor or
645 (iii) a pharmacy licensed under this title
- 21 Senate Committee Amendments 2-13-2014 Jplcjd
1st Sub (Green) SB 55 02-07-14 416 PM
646 Section 9 Section 58-17b-803 is enacted to read
647 58-17b-803 Qualifications for licensure as a dispensing medical practitioner -shy
648 Scope of practice
649 (1) An applicant for a license as a dispensing medical practitioner shall
650 (a) be licensed in good standing under at least one of the chapters listed in Subsection
651 58-17b-l02(23)(a) and
652 (b) submit an application for a license as a dispensing medical practitioner in a form
653 prescribed by the division and pay a fee established by the S [depal tment] divisionS ~
654 (2) The division shall accept the licensing in good standing under Subsection (1) in lieu
655 of requiring an applicant for a license under this part to comply with Sections 58-17b-303 and
656
657 (3) A dispensing medical practitioner may dispense in accordance with this part
658 (a) a cosmetic drug and an injectable weight loss drug if
659 (i) the drug was prescribed by the dispensing medical practitioner to the dispensing
660 medical practitioners patient and
661 Oi) the dispensing medical practitioner complies with administrative rules adopted by
662 the division under Subsection 58-17-802(1)
663 (b) a cancer drug treatment regimen if the dispensing medical practitioner complies
664 with Section 58-17b-805 and
665 (c) a pre-packaged drug to an employee or a dependent of an employee at an employer
666 sponsored clinic if the dispensing medical practitioner
667 (i) treats an employee or the dependent of an employee of one of an exclusive group
668 of employers at an employer sponsored clinic
669 (ii) prescribes a prepackaged drug to the employee or the employees dependent
670 (iii) dispenses the prepackaged drug at the employer sponsored clinic and
671 (iv) complies with administrative rules adopted by the division in consultation with the
672 Board of Pharmacy that establish labeling record keeping patient counseling purchasing and
673 distribution operating treatment quality of care and storage requirements
674 (4) A dispensing medical practitioner
675 Ca) shall inform the patient
676 (i) that the drug dispensed by the practitioner may be obtained from a pharmacy
- 22 - Senate Committee Amendments 2-13-2014 picjd
02-07-14 416 PM 1st Sub (Green) SB 55
739 58-17b-806 Dispensing medical practitioner -- Dispensing medical practitioner
740 clinic pharmacy -- Unprofessional and Unlawful conduct
741 ill S Ull S The division S [ iii consultation witb tile boal d shall
742 (a) I epol t a violation of this chapter b a dispensing medical pi actitiollel to] shall consult
742a with S the
743 dispensing medical practitioners appropriate licensing board as designated in Subsection
744 5S-17b-l02(23)(a) S reeardine a violation oftMs chapterS and
745 (hl S the Pharmacy Board shall if requested by the licensine board of the dispensine
745a medical practitionerS assist the licensing board for the dispensing medical practitioner with
745b reviewing the
746 violations of the provisions of this chapter
747 (2) The division S [ in collabOi atioll with the Boal d ofPhall1l3C]S may take
747a appropriate
748 action against a dispensing medical practitioner in accordance with this chapter if the
749 licensing board designated in Subsection 58-17b- 02(23)(a) recommends to the division that
750 action be taken under this chapter
751 (3) The division in consultation with the board is the primary enforcer under this
752 chapter for a dispensing medical practitioner clinic pharmacy licensed under Section
753 58-17b-804
754 Section 13 Section 58-31b-502 is amended to read
755 58-31b-502 Unprofessional conduct
756 Unprofessional conduct includes
757 (l) failure to safeguard a patients right to privacy as to the patients person condition
758 diagnosis personal effects or any other matter about which the licensee is privileged to know
759 because of the licensees or person with a certifications position or practice as a nurse or
760 practice as a medication aide certified
761 (2) failure to provide nursing service or service as a medication aide certified in a
762 manner that demonstrates respect for the patients human dignity and unique personal character
763 and needs without regard to the patients race religion ethnic background socioeconomic
764 status age sex or the nature of the patients health problem
765 (3) engaging in sexual relations with a patient during any
766 (a) period when a generally recognized professional relationship exists between the
767 person licensed or certified under this chapter and patient or
768 (b) extended period when a patient has reasonable cause to believe a professional
769 relationship exists between the person licensed or certified under the provisions of this chapter
- 25 - Senate Committee Amendments 2-13-2014Iplcjd
LEGISLA TIVE GENERAL COUNSEL SB138 ct Approved for Filing Sc Allred ct
ct 02-04-14 1220 PM ct
1 CONTROLLED SUBSTANCES ACT AMENDMENTS
2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Evan J Vickers
5 House Sponsor Stewart Barlow
6
7 LONG TITLE
8 General Description
9 This bill modifies the Utah Controlled Substances Act regarding prescriptions for
10 controlled substances
11 Highlighted Provisions
12 This bill
13 ~ provides that more than one controlled substance may be included in a prescription
14 Money Appropriated in this Bill
15 None
16 Other Special Clauses
17 None
18 Utah Code Sections Affected
19 AMENDS
20 58-37-6 as last amended by Laws of Utah 2012 Chapter 272
21
22 Be it enacted by the Legislature of the state ofUtah
23 Section 1 Section 58-37-6 is amended to read
24 58-37-6 License to manufacture produce distribute dispense administer or
25 conduct research -- Issuance by division -- Denial suspension or revocation -- Records
26
27
required -- Prescriptions
(1) (a) The division may adopt rules relating to the licensing and control of the bull
1111111111111111111111111111111111111111
SB138 02-04-14 1220 PM
214 (ii) the prescribed controlled substance is to be used in research
215 (f) Except when administered directly to an ultimate user by a licensed practitioner
216 controlled substances are subject to the following restrictions
217 (i) (A) A prescription for a Schedule IT substance may not be refilled
218 (B) A Schedule II controlled substance may not be filled in a quantity to exceed a
219 one-months supply as directed on the daily dosage rate of the prescriptions
220 (ii) A Schedule ill or IV controlled substance may be filled only within six months of
221 issuance and may not be refilled more than six months after the date of its original issuance or
222 be refilled more than five times after the date of the prescription unless renewed by the
223 practitioner
224 (iii) All other controlled substances in Schedule V may be refilled as the prescribers
225 prescription directs but they may not be refilled one year after the date the prescription was
226 issued unless renewed by the practitioner
227 (iv) Any prescription for a Schedule IT substance may not be dispensed if it is not
228 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days
229 after the date the prescription was issued or 30 days after the dispensing date if that date is
230 specified separately from the date of issue
231 (v) A practitioner may issue more than one prescription at the same time for the same
232 Schedule IT controlled substance but only under the following conditions
233 (A) no more than three prescriptions for the same Schedule IT controlled substance may
234 be issued at the same time
235 (B) no one prescription may exceed a 30-day supply
236 (C) a second or third prescription shall include the date of issuance and the date for
237 dispensing and
238 (D) unless the practitioner determines there is a valid medical reason to the contrary
239 the date for dispensing a second or third prescription may not be fewer than 30 days from the
240 dispensing date of the previous prescription
241 [(1i) Each prescription rot a controlled snbstance may eontain only one controlled
242 substance per pIescription frlim and may not contain any other legend dmg 01 prescription
243 item]
244 (g) An order for a controlled substance in Schedules IT through V for use by an
- 8 shy
LEGISLATIVE GENERAL COUNSEL it Approved for Filing CJ Dupont it
HB114
it 02-06-14855 AM it
1 MAIL-ORDER WHOLESALE DRUG AMENDMENTS 2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Stewart Barlow
5 Senate Sponsor ______
6
7 LONG TITLE
8 General Description
9 This bill amends the Pharmacy Practice Act
10 Highlighted Provisions
11 This bill
12 ~ amends the definition of a class C pharmacy subject to regulation under the
13 Pharmacy Practice Act
14 Money Appropriated in this Bill
15 None
16 Other Special Clauses
17 This bi II takes effect on July 1 2014
18 Utah Code Sections Affected
19 AMENDS
20 58-17b-102 as last amended by Laws of Utah 2013 Chapters 52 166 and 423
21
22 Be it enacted by the Legislature ofthe state ofUtah
23 Section 1 Section 58-17b-102 is amended to read
24 58-17b-102 Definitions
25 In addition to the definitions in Section 58-1-102 as used in this chapter
26
27
(1) Administering means
(a) the direct application of a prescription drug or device whether by injection
==bull =bull
1111111111111111111111111111111111111111
02-06-14855 AM HB114
59 (9) Centralized prescription processing means the processing by a pharmacy of a
60 request from another pharmacy to fill or refill a prescription drug order or to perform
61 processing functions such as dispensing drug utilization review claims adjudication refill
62 authorizations and therapeutic interventions
63 (10) Class A pharmacy means a pharmacy located in Utah that is authorized as a
64 retail pharmacy to compound or dispense a drug or dispense a device to the public under a
65 prescription order
66 (11) Class B pharmacy
67 (a) means a pharmacy located in Utah
68 (i) that is authorized to provide pharmaceutical care for patients in an institutional
69 setting and
70 (ii) whose primary purpose is to provide a physical environment for patients to obtain
71 health care services and
72 (b) (i) includes closed-door hospital clinic nuclear and branch pharmacies and
73 (ii) pharmaceutical administration and sterile product preparation facilities
74 (12) Class C pharmacy means a pharmacy [located ill Utah that is anthOl ized to
75 engage] that engages in the manufacture production wholesale or distribution of drugs or
76 devices in Utah
77 (13) Class D pharmacy means a nonresident pharmacy
78 (14) Class E pharmacy means all other pharmacies
79 (15) Closed-door pharmacy means a pharmacy that provides pharmaceutical care to a
80 defined and exclusive group of patients who have access to the services of the pharmacy
81 because they are treated by or have an affiliation with a specific entity including a health
82 maintenance organization or an infusion company but not including a hospital pharmacy a
83 retailer of goods to the general public or the office of a practitioner
84 (16) Collaborative pharmacy practice means a practice of pharmacy whereby one or
85 more pharmacists have jointly agreed on a voluntary basis to work in conjunction with one or
86 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical
87 care functions authorized by the practitioner or practitioners under certain specified conditions
88 or limitations
89 (17) Collaborative pharmacy practice agreement means a written and signed
- 3 shy
02-06-14855 AM HB114
369 and
370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in
371 collaboration with the board
372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501
373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and
374 may be further defined by rule
375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that
376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration
377 for animals
378 Section 2 Effective date
379 This bill takes effect on July I 2014
Legislative Review Note as of 2-4-14 1243 PM
Office of Legislative Research and General Counsel
- 13 shy
LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t
t 02-05-14 122PM t
1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG
2 AMENDMENTS
3 2014 GENERAL SESSION
4 STATE OF UTAH
5 Chief Sponsor Stewart Barlow
6 Senate Sponsor
7
8 LONG TITLE
9 General Description
10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from
11 its licensing requirements under certain circumstances
12 Highlighted Provisions
13 This bill
14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy
15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an
16 employer sponsored clinic and complies with other requirements
17 repeals subject to sunset review the provisions of this bill relating to the exemption
18 described above and
19 ~ makes technical and conforming changes
20 Money Appropriated in this Bill
21 None
22 Other Special Clauses
23 None
24 Utah Code Sections Affected
25 AMENDS
26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~
27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull
1111111111111111111111111111111111111111
HBI06 02-05-14 122 PM
28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278
29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234
30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351
31 ENACTS
32 58-17b-3097 Utah Code Annotated 1953
33
34 Be it enacted by the Legislature ofthe state ofUtah
35 Section 1 Section 58-17b-301 is amended to read
36 58-17b-301 License required -- License classifications for individuals
37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the
38 practice of a pharmacy technician except as specifically provided in Section 58-1-307
39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097
40 (2) The division shall issue to an individual who qualifies under this chapter a license
41 in the classification of
42 (a) pharmacist
43 (b) pharmacy intern or
44 (c) pharmacy technician
45 Section 2 Section 58-17b-302 is amended to read
46 58-17b-302 License required -- License classifications for pharmacy facilities
47 (l) A license is required to act as a pharmacy except as specifically exempted from
48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or
49
50 (2) The division shall issue a pharmacy license to a facility that qualifies under this
51 chapter in the classification of a
52 (a) class A pharmacy
53 (b) class B pharmacy
54 (c) class C pharmacy
55 (d) class D pharmacy or
56 (e) class E pharmacy
57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist
58 at the same address a separate license shall be required for each pharmacy
-2shy
02-05-14 122 PM HBI06
59 (4) The division may further define or supplement the classifications of pharmacies
60 The division may impose restrictions upon classifications to protect the public health safety
61 and welfare
62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by
63 rule
64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy
65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities
66 of the pharmacy regardless of the form of the business organization
67 Section 3 Section 58-17b-309 is amended to read
68 58-17b-309 Exemptions from licensure
69 (l) [For ptnp05C5 of] As used in this section
70 (a) Cosmetic drug
71 (i) means a prescription drug that is
72 (A) for the purpose of promoting attractiveness or altering the appearance of an
73 individual and
74 (8) listed as a cosmetic drug subject to the exemption under this section by the division
75 by administrative rule or has been expressly approved for online dispensing whether or not it is
76 dispensed online or through a physicians office and
77 (ii) does not include a prescription drug that is
78 (A) a controlled substance
79 (8) compounded by the physician or
80 (C) prescribed or used for the patient for the purpose of diagnosing curing or
81 preventing a disease
82 (b) Injectable weight loss drug
83 (i) means an injectable prescription drug
84 (A) prescribed to promote weight loss and
85 (8) listed as an injectable prescription drug subject to exemption under this section by
86 the division by administrative rule and
87 (ii) does not include a prescription drug that is a controlled substance
88 (c) Prescribing practitioner means an individual licensed under
89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with
- 3 shy
HB106 02-05-14 122 PM
90 prescriptive practice
91 (ii) Chapter 67 Utah Medical Practice Act
92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or
93 (iv) Chapter 70a Physician Assistant Act
94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l
95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the
96 acts or practices described in this section without being licensed under this chapter
97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the
98 individual notifies the division in writing of the individuals intent to dispense a drug under this
99 [snbsectioll] Subsection (2)
100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1
101 (c) an individual engaging in the practice of pharmacy technician under the direct
102 personal supervision of a pharmacist while making satisfactory progress in an approved
103 program as defined in division rule
104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an
105 injectable weight loss drug to the prescribing practitioners patient in accordance with
106 Subsection (4) or
107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists
108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic
109 drug to the optometrists patient in accordance with Subsection (4)
110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under
111 Subsection (2)( c) must take all examinations as required by division rule following completion
112 of an approved curriculum of education within the required time frame This exemption
113 expires immediately upon notification of a failing score of an examination and the individual
114 may not continue working as a pharmacy technician even under direct supervision
115 (4) A prescribing practitioner or optometrist is exempt from licensing under the
116 provisions of this part if the prescribing practitioner or optometrist
117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the
118 authority to dispense under Subsection (4)(b) and
119 (ii) informs the patient
120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing
-4shy
HB106 02-05-14 122 PM
152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the
153 prescribing practitioners or optometrists office and determine if the provisions of this section
154 are being met by the prescribing practitioner or optometrist
155 (d) If a prescribing practitioner or optometrist violates a provision of this section the
156 prescribing practitioner or optometrist may be subject to discipline under
157 (i) this chapter and
158 (ii) (A) Chapter 16a Utah Optometry Practice Act
159 (B) Chapter 31 b Nurse Practice Act
160 (C) Chapter 67 Utah Medical Practice Act
161 (D) Chapter 68 Utah Osteopathic Medical Practice Act
162 (E) Chapter 70a Physician Assistant Act or
163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act
164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the
165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah
166 Optometry Practice Act
167 Section 4 Section 58-17b-3095 is amended to read
168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy
169 Division study of dispensing practitioners
170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen
171 (a) means a prescription drug used to treat cancer manage its symptoms or provide
172 continuity of care for a cancer patient
173 (b) includes
174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal
175 methods and
176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize
177 physical and psychological symptoms or pain or to improve patient tolerance of cancer
178 treatments or prepare a patient for a subsequent course of therapy and
179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug
180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections
181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt
182 from licensure under this chapter
- 6shy
HB106 02-05-14 122 PM
214 (ii) is acting under the direction of a prescribing practitioner who is immediately
215 available on site for any necessary consultation and who has complied with Subsection
216 (2)(b)(i)
217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the
218 outpatient clinic setting and
219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)
220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to
221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section
222 (b) The evaluation under this Subsection (3) shall include
223 (i) practitioner compliance with the requirements of this section and Section
224 58-l7b-309
225 (ii) current research on dispensing and patient safety
226 (iii) survey of other state dispensing laws and
227 (iv) recommendations for future action concerning practitioner dispensing
228 (c) The division shall report to the Legislatures Health and Human Services Interim
229 Committee by November 302012 and by November 302013 with the results and
230 recommendations from the evaluation required by this Subsection (3)
231 (4) This section sunsets in accordance with Section 631-1-258
232 Section 5 Section 58-17b-3097 is enacted to read
233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an
234 employer sponsored clinic
235 (1) As used in this section
236 (a) Employer sponsored clinic means an entity that offers health care only to the
237 employees of an exclusive group of employers and the employees dependents
238 (b) Health care is as defined in Section 31 A-J-301
239 (c) Prepackaged drug means a prescription drug that
240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and
241 (ii) is packaged in a fixed quantity per package by
242 (A) the drug manufacturer
243 (B) a pharmaceutical wholesaler or distributor or
244 (C) a pharmacy licensed under this title
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~ -- -------------------
02-05-14 122 PM HB106
245 Cd) Prescribing practitioner is as defined in Section 58-17b-309
246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309
247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing
248 requirements of this chapter if the prescribing practitioner
249 Ca) treats an employee of one of an exclusive group of employers at an employer
250 sponsored clinic
251 Cb) prescribes a prepackaged drug to the employee
252 Cc) dispenses the prepackaged drug at the employer sponsored clinic
253 (d) notifies the division
254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the
255 employer sponsored clinic and
256 (ii) of the drug the prescribing practitioner intends to dispense
257 Ce) determines that providing the prepackaged drug to the employee at the employer
258 sponsored clinic is in the employees best interest
259 (f) informs the employee
260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner
261 from a pharmacy that is unaffiliated with the prescribing practitioner
262 (ii) of the directions for appropriate use of the prepackaged drug
263 (iii) of potential side effects to the use of the prepackaged drug and
264 (iv) how to contact the prescribing practitioner if the employee has questions or
265 concerns regarding the drug
266 (g) offers the employee the opportunity to consult with a pharmacist if the employee
267 asks for patient counseling and
268 (h) follows the administrative rules for a prescribing practitioner at an employer
269 sponsored clinic established by the division under Subsection (4)
270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a
271 prepackaged drug under this section requires physician supervision in its scope ofpractice
272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the
273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter
274 68 Utah Osteopathic Medical Practice Act
275 (4) The division shall in consultation with the board of pharmacy and the Physicians
- 9 shy
HBI06 02-05-14 122 PM
276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title
277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping
278 patient counseling purchasing and distribution operating treatment quality of care and
279 storage requirements for a prescribing practitioner at an employer sponsored clinic
280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a
281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing
282 practitioner is in compliance with this section
283 (6) If a prescribing practitioner violates a provision of this section the prescribing
284 practitioner may be subject to discipline under
285 (a) this chapter and
286 (b) any other chapter that governs the terms of the prescribing practitioners license
287 (7) The division shall evaluate the exemption created by this section and report to the
288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1
289 2018 on the results of the evaluation and the divisions recommendations regarding the
290 exemption
291 Section 6 Section 631-1-258 is amended to read
292 631-1-258 Repeal dates Title 58
293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is
294 repealed July 12016
295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015
296 (3) Section 58-17b-3095 is repealed July 1 2015
297 (4) Section 58-17b-3097 is repealed on July 12018
298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1
299 2018
300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1
301 2023
302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing
303 Act is repealed July 1 2019
304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1
305 2015
306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is
- 10shy
02-05-14 1 22 PM HB106
307 repealed July 12023
308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1
309 2014
310 [ttej] ill) Section 58-69-3025 is repealed on July 12015
311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017
Legislative Review Note as of 2-3-14 418 PM
Office of Legislative Research and General Counsel
- 11 shy
LEGISLA TIVE GENERAL COUNSEL SB178 ct Approved for Filing Sc Allred ct
ct 02-05-14 1 56 PM ct
1 CONTROLLED SUBSTANCE DATABASE MODIFICATIONS
2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Evan J Vickers
5 House Sponsor Bradley G Last
6
7 LONG TITLE
8 General Description
9 This bill modifies the Controlled Substance Database Act regarding access by pharmacy
10 technicians
11 Highlighted Provisions
12 This bill
13 ~ allows the phannacist-in-charge to designate a licensed phannacy technician to have
14 access to the database on behalf of the phannacist in accordance with statutory
15 requirements
16 Money Appropriated in this Bill
17 None
18 Other Special Clauses
19 None
20 Utah Code Sections Affected
21 AMENDS
22 58-37fmiddot301 as last amended by Laws of Utah 2013 Chapters 12 130 and 262
23
24 Be it enacted by the Legislature ofthe state ofUtah
25
26
27
Section 1 Section 58-37fmiddot301 is amended to read
58-37fmiddot301 Access to database
(1) The division shall make rules in accordance with Title 63G Chapter 3 Utah
rJlbull =bull
1111111111111111111111111111111111111111
02-05-14 156 PM SB178
59 (A) fit within the responsibilities of the Department of Health for health and welfare
60 (B) are reviewed and approved by an Institutional Review Board that is approved for
61 human subject research by the United States Department of Health and Human Services and
62 (C) are not conducted for profit or commercial gain and
63 (D) are conducted in a research facility as defined by division rule that is associated
64 with a university or college in the state accredited by the Northwest Commission on Colleges
65 and Universities
66 (iii) the designee protects the information as a business associate of the Department of
67 Health and
68 (iv) the identity of the prescribers patients and pharmacies in the database are
69 de-identified confidential not disclosed in any manner to the designee or to any individual
70 who is not directly involved in the scientific studies
71 (e) a licensed practitioner having authority to prescribe controlled substances to the
72 extent the information
73 (i) (A) relates specifically to a current or prospective patient of the practitioner and
74 (B) is provided to or sought by the practitioner for the purpose of
75 (I) prescribing or considering prescribing any controlled substance to the current or
76 prospective patient
77 (II) diagnosing the current or prospective patient
78 (nn providing medical treatment or medical advice to the current or prospective
79 patient or
80 (IV) determining whether the current or prospective patient
81 (Aa) is attempting to fraudulently obtain a controlled substance from the practitioner
82 or
83 (Bb) has fraudulently obtained or attempted to fraudulently obtain a controlled
84 substance from the practitioner
85 (ii) (A) relates specifically to a fonner patient of the practitioner and
86 (B) is provided to or sought by the practitioner for the purpose of determining whether
87 the former patient has fraudulently obtained or has attempted to fraudulently obtain a
88 controlled substance from the practitioner
89 (iii) relates specifically to an individual who has access to the practitioners Drug
- 3 shy
02-05-14 156 PM SB178
121 58-3 7f-203(3 )(b) with respect to the employee
122 (h) a licensed pharmacist having authority to dispense a controlled substance to the
123 extent the information is provided or sought for the purpose of
124 (i) dispensing or considering dispensing any controlled substance or
125 (ii) determining whether a person
126 (A) is attempting to fraudulently obtain a controlled substance from the pharmacist or
127 (B) has fraudulently obtained or attempted to fraudulently obtain a controlled
128 substance from the pharmacist
129 (i) in accordance with Subsection (3)(a) a licensed pharmacy technician who is an
]30 employee of a pharmacy as defined in Section 58-17b-l 02 for the purposes described in
131 Subsection (2)(h)(i) or (iO if
132 0) the employee is designated by the pharmacist-in-charge as an individual authorized
133 to access the information on behalf of a licensed pharmacist employed by the pharmacy
134 (ii) the pharmacist-in-charge provides written notice to the division of the identity of
135 the employee and
136 (iii) the division
137 CA) grants the employee access to the database and
138 (B) provides the employee with a password that is unique to that employee to access
139 the database in order to permit the division to comply with the requirements of Subsection
140 58-37f-203(3)(b) with respect to the employee
141 [fiJ] ill federal state and local law enforcement authorities and state and local
142 prosecutors engaged as a specified duty of their employment in enforcing laws
143 (i) regulating controlled substances
144 (ii) investigating insurance fraud Medicaid fraud or Medicare fraud or
145 (iii) providing information about a criminal defendant to defense counsel upon request
146 during the discovery process for the purpose of establishing a defense in a criminal case
147 [61] fhl employees ofthe Office oflntemal Audit and Program Integrity within the
148 Department of Health who are engaged in their specified duty of ensuring Medicaid program
149 integrity under Section 26-18-23
150 [fki] ill a mental health therapist if
151 (i) the information relates to a patient who is
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02-05-14 156 PM SB178
183 designated under Subsection (2)(f) (2)(g) or (4)(c) should be granted access to the database
184 and
185 (ii) establish the information to be provided by an emergency room employee under
186 Subsection (4)
187 (c) The division shall grant an employee designated under Subsection (2)(f) (2)(g) or
188 (4)( c) access to the database unless the division determines based on a background check that
189 the employee poses a security risk to the information contained in the database
190 (4) (a) An individual who is employed in the emergency room ofa hospital may
191 exercise access to the database under this Subsection (4) on behalf of a licensed practitioner if
192 the individual is designated under Subsection (4)( c) and the licensed practitioner
193 (i) is employed in the emergency room
194 Oi) is treating an emergency room patient for an emergency medical condition and
195 (iii) requests that an individual employed in the emergency room and designated under
196 Subsection (4)( c) obtain information regarding the patient from the database as needed in the
197 course of treatment
198 (b) The emergency room employee obtaining information from the database shall
199 when gaining access to the database provide to the database the name and any additional
200 identifiers regarding the requesting practitioner as required by division administrative rule
201 established under Subsection (3)(b)
202 (c) An individual employed in the emergency room under this Subsection (4) may
203 obtain information from the database as provided in Subsection (4)(a) if
204 (i) the employee is designated by the practitioner as an individual authorized to access
205 the information on behalf of the practitioner
206 (ii) the practitioner and the hospital operating the emergency room provide written
207 notice to the division of the identity of the designated employee and
208 (iii) the division
209 (A) grants the employee access to the database and
210 (B) provides the employee with a password that is unique to that employee to access
211 the database in order to permit the division to comply with the requirements of Subsection
212 58-37f-203(3)(b) with respect to the employee
213 (d) The division may impose a fee in accordance with Section 63J-I-504 on a
- 7
LEGISLATIVE GENERAL C01JNSEL SB55 iL Approved for Filing Cl Dupont iL lst Sub (Green)
iL 02-07-14 416 PM iL
Senator Evan J Vickers proposes the following substitute bill
PHARMACEUTICAL DISPENSING AMENDMENTS
2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Evan J Vickers
5 House Sponsor Stewart Barlow
6
7 LONG TITLE
8 General Description
9 This bill amends the Pharmacy Practice Act to create a dispensing medical practitioner
10 license and a license classification for a dispensing medical practitioner clinic
11 pharmacy
12 Highlighted Provisions
13 This bill
14 defines terms
15 establishes the license classification dispensing medical practitioner under the
16 Pharmacy Practice Act for medical practitioners who prescribe and dispense a drug
17 establishes the pharmacy facility license classification dispensing medical
18 practitioner clinic pharmacy under the Pharmacy Practice Act
19 creates Part 8 Dispensing Medical Practitioner and Dispensing Medical Practitioner
20 Clinic Pharmacy
21 removes the exemption from the Pharmacy Practice Act for medical practitioners
22 who prescribe and dispense a cosmetic drug injectable weight loss drug or a cancer
23 drug treatment regimen
24 requires a license as a dispensing medical practitioner for a health care practitioner 00
25 to dispense bull bull=
1111111111111111111111111111111111111111111111111111111
02-07-14 416 PM 1st Sub (Green) SB 55
615 Practitioner Clinic Pharmacy II
616 Section 8 Section 58-17b-802 is enacted to read
617 58-17b-802 Definitions
618 As used in this part
619 (1) (a) Cosmetic drug means a prescription drug that
620 (i) is for the purpose of promoting attractiveness or altering the appearance of an
621 individual and
622 (ii) (A) is listed as a cosmetic drug subject to the exemption under this section by the
623 division by administrative rule or
624 CB) has been expressly approved for online dispensing whether or not it is dispensed
625 online or through a physicians office
626 (b) Cosmetic drug does not include a prescription drug that is
627 (i) a controlled substance
628 (ii) compounded by the physician or
629 (iii) prescribed or used for the patient for the purpose of diagnosing curing or
630 preventing a disease
631 (2) Employer sponsored clinic means an entity that S-t has a medical director who is
631 a licensed as a physician as defined in Section 58-67-102 and S offers health care only to the
632 employees of an exclusive group of employers and the employees dependents
633 (3) Health care is as defined in Section 31A-1-301
634 (4) Ca) Injectable weight loss drug means an injectable prescription drug
635 (n prescribed to promote weight loss and
636 (ii) listed as an injectable prescription drug subject to exemption under this section by
637 the division by administrative rule
638 (b) Injectable weight loss drug does not include a prescription drug that is a
639 controlled substance
640 (5) Prepackaged drug means a prescription drug that
641 (a) is not listed under federal or state law as a Schedule I II ill IV or V drug and
642 (b) is packaged in a fixed quantity per package by
643 (i) the drug manufacturer
644 (ii) a pharmaceutical wholesaler or distributor or
645 (iii) a pharmacy licensed under this title
- 21 Senate Committee Amendments 2-13-2014 Jplcjd
1st Sub (Green) SB 55 02-07-14 416 PM
646 Section 9 Section 58-17b-803 is enacted to read
647 58-17b-803 Qualifications for licensure as a dispensing medical practitioner -shy
648 Scope of practice
649 (1) An applicant for a license as a dispensing medical practitioner shall
650 (a) be licensed in good standing under at least one of the chapters listed in Subsection
651 58-17b-l02(23)(a) and
652 (b) submit an application for a license as a dispensing medical practitioner in a form
653 prescribed by the division and pay a fee established by the S [depal tment] divisionS ~
654 (2) The division shall accept the licensing in good standing under Subsection (1) in lieu
655 of requiring an applicant for a license under this part to comply with Sections 58-17b-303 and
656
657 (3) A dispensing medical practitioner may dispense in accordance with this part
658 (a) a cosmetic drug and an injectable weight loss drug if
659 (i) the drug was prescribed by the dispensing medical practitioner to the dispensing
660 medical practitioners patient and
661 Oi) the dispensing medical practitioner complies with administrative rules adopted by
662 the division under Subsection 58-17-802(1)
663 (b) a cancer drug treatment regimen if the dispensing medical practitioner complies
664 with Section 58-17b-805 and
665 (c) a pre-packaged drug to an employee or a dependent of an employee at an employer
666 sponsored clinic if the dispensing medical practitioner
667 (i) treats an employee or the dependent of an employee of one of an exclusive group
668 of employers at an employer sponsored clinic
669 (ii) prescribes a prepackaged drug to the employee or the employees dependent
670 (iii) dispenses the prepackaged drug at the employer sponsored clinic and
671 (iv) complies with administrative rules adopted by the division in consultation with the
672 Board of Pharmacy that establish labeling record keeping patient counseling purchasing and
673 distribution operating treatment quality of care and storage requirements
674 (4) A dispensing medical practitioner
675 Ca) shall inform the patient
676 (i) that the drug dispensed by the practitioner may be obtained from a pharmacy
- 22 - Senate Committee Amendments 2-13-2014 picjd
02-07-14 416 PM 1st Sub (Green) SB 55
739 58-17b-806 Dispensing medical practitioner -- Dispensing medical practitioner
740 clinic pharmacy -- Unprofessional and Unlawful conduct
741 ill S Ull S The division S [ iii consultation witb tile boal d shall
742 (a) I epol t a violation of this chapter b a dispensing medical pi actitiollel to] shall consult
742a with S the
743 dispensing medical practitioners appropriate licensing board as designated in Subsection
744 5S-17b-l02(23)(a) S reeardine a violation oftMs chapterS and
745 (hl S the Pharmacy Board shall if requested by the licensine board of the dispensine
745a medical practitionerS assist the licensing board for the dispensing medical practitioner with
745b reviewing the
746 violations of the provisions of this chapter
747 (2) The division S [ in collabOi atioll with the Boal d ofPhall1l3C]S may take
747a appropriate
748 action against a dispensing medical practitioner in accordance with this chapter if the
749 licensing board designated in Subsection 58-17b- 02(23)(a) recommends to the division that
750 action be taken under this chapter
751 (3) The division in consultation with the board is the primary enforcer under this
752 chapter for a dispensing medical practitioner clinic pharmacy licensed under Section
753 58-17b-804
754 Section 13 Section 58-31b-502 is amended to read
755 58-31b-502 Unprofessional conduct
756 Unprofessional conduct includes
757 (l) failure to safeguard a patients right to privacy as to the patients person condition
758 diagnosis personal effects or any other matter about which the licensee is privileged to know
759 because of the licensees or person with a certifications position or practice as a nurse or
760 practice as a medication aide certified
761 (2) failure to provide nursing service or service as a medication aide certified in a
762 manner that demonstrates respect for the patients human dignity and unique personal character
763 and needs without regard to the patients race religion ethnic background socioeconomic
764 status age sex or the nature of the patients health problem
765 (3) engaging in sexual relations with a patient during any
766 (a) period when a generally recognized professional relationship exists between the
767 person licensed or certified under this chapter and patient or
768 (b) extended period when a patient has reasonable cause to believe a professional
769 relationship exists between the person licensed or certified under the provisions of this chapter
- 25 - Senate Committee Amendments 2-13-2014Iplcjd
LEGISLA TIVE GENERAL COUNSEL SB138 ct Approved for Filing Sc Allred ct
ct 02-04-14 1220 PM ct
1 CONTROLLED SUBSTANCES ACT AMENDMENTS
2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Evan J Vickers
5 House Sponsor Stewart Barlow
6
7 LONG TITLE
8 General Description
9 This bill modifies the Utah Controlled Substances Act regarding prescriptions for
10 controlled substances
11 Highlighted Provisions
12 This bill
13 ~ provides that more than one controlled substance may be included in a prescription
14 Money Appropriated in this Bill
15 None
16 Other Special Clauses
17 None
18 Utah Code Sections Affected
19 AMENDS
20 58-37-6 as last amended by Laws of Utah 2012 Chapter 272
21
22 Be it enacted by the Legislature of the state ofUtah
23 Section 1 Section 58-37-6 is amended to read
24 58-37-6 License to manufacture produce distribute dispense administer or
25 conduct research -- Issuance by division -- Denial suspension or revocation -- Records
26
27
required -- Prescriptions
(1) (a) The division may adopt rules relating to the licensing and control of the bull
1111111111111111111111111111111111111111
SB138 02-04-14 1220 PM
214 (ii) the prescribed controlled substance is to be used in research
215 (f) Except when administered directly to an ultimate user by a licensed practitioner
216 controlled substances are subject to the following restrictions
217 (i) (A) A prescription for a Schedule IT substance may not be refilled
218 (B) A Schedule II controlled substance may not be filled in a quantity to exceed a
219 one-months supply as directed on the daily dosage rate of the prescriptions
220 (ii) A Schedule ill or IV controlled substance may be filled only within six months of
221 issuance and may not be refilled more than six months after the date of its original issuance or
222 be refilled more than five times after the date of the prescription unless renewed by the
223 practitioner
224 (iii) All other controlled substances in Schedule V may be refilled as the prescribers
225 prescription directs but they may not be refilled one year after the date the prescription was
226 issued unless renewed by the practitioner
227 (iv) Any prescription for a Schedule IT substance may not be dispensed if it is not
228 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days
229 after the date the prescription was issued or 30 days after the dispensing date if that date is
230 specified separately from the date of issue
231 (v) A practitioner may issue more than one prescription at the same time for the same
232 Schedule IT controlled substance but only under the following conditions
233 (A) no more than three prescriptions for the same Schedule IT controlled substance may
234 be issued at the same time
235 (B) no one prescription may exceed a 30-day supply
236 (C) a second or third prescription shall include the date of issuance and the date for
237 dispensing and
238 (D) unless the practitioner determines there is a valid medical reason to the contrary
239 the date for dispensing a second or third prescription may not be fewer than 30 days from the
240 dispensing date of the previous prescription
241 [(1i) Each prescription rot a controlled snbstance may eontain only one controlled
242 substance per pIescription frlim and may not contain any other legend dmg 01 prescription
243 item]
244 (g) An order for a controlled substance in Schedules IT through V for use by an
- 8 shy
LEGISLATIVE GENERAL COUNSEL it Approved for Filing CJ Dupont it
HB114
it 02-06-14855 AM it
1 MAIL-ORDER WHOLESALE DRUG AMENDMENTS 2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Stewart Barlow
5 Senate Sponsor ______
6
7 LONG TITLE
8 General Description
9 This bill amends the Pharmacy Practice Act
10 Highlighted Provisions
11 This bill
12 ~ amends the definition of a class C pharmacy subject to regulation under the
13 Pharmacy Practice Act
14 Money Appropriated in this Bill
15 None
16 Other Special Clauses
17 This bi II takes effect on July 1 2014
18 Utah Code Sections Affected
19 AMENDS
20 58-17b-102 as last amended by Laws of Utah 2013 Chapters 52 166 and 423
21
22 Be it enacted by the Legislature ofthe state ofUtah
23 Section 1 Section 58-17b-102 is amended to read
24 58-17b-102 Definitions
25 In addition to the definitions in Section 58-1-102 as used in this chapter
26
27
(1) Administering means
(a) the direct application of a prescription drug or device whether by injection
==bull =bull
1111111111111111111111111111111111111111
02-06-14855 AM HB114
59 (9) Centralized prescription processing means the processing by a pharmacy of a
60 request from another pharmacy to fill or refill a prescription drug order or to perform
61 processing functions such as dispensing drug utilization review claims adjudication refill
62 authorizations and therapeutic interventions
63 (10) Class A pharmacy means a pharmacy located in Utah that is authorized as a
64 retail pharmacy to compound or dispense a drug or dispense a device to the public under a
65 prescription order
66 (11) Class B pharmacy
67 (a) means a pharmacy located in Utah
68 (i) that is authorized to provide pharmaceutical care for patients in an institutional
69 setting and
70 (ii) whose primary purpose is to provide a physical environment for patients to obtain
71 health care services and
72 (b) (i) includes closed-door hospital clinic nuclear and branch pharmacies and
73 (ii) pharmaceutical administration and sterile product preparation facilities
74 (12) Class C pharmacy means a pharmacy [located ill Utah that is anthOl ized to
75 engage] that engages in the manufacture production wholesale or distribution of drugs or
76 devices in Utah
77 (13) Class D pharmacy means a nonresident pharmacy
78 (14) Class E pharmacy means all other pharmacies
79 (15) Closed-door pharmacy means a pharmacy that provides pharmaceutical care to a
80 defined and exclusive group of patients who have access to the services of the pharmacy
81 because they are treated by or have an affiliation with a specific entity including a health
82 maintenance organization or an infusion company but not including a hospital pharmacy a
83 retailer of goods to the general public or the office of a practitioner
84 (16) Collaborative pharmacy practice means a practice of pharmacy whereby one or
85 more pharmacists have jointly agreed on a voluntary basis to work in conjunction with one or
86 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical
87 care functions authorized by the practitioner or practitioners under certain specified conditions
88 or limitations
89 (17) Collaborative pharmacy practice agreement means a written and signed
- 3 shy
02-06-14855 AM HB114
369 and
370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in
371 collaboration with the board
372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501
373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and
374 may be further defined by rule
375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that
376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration
377 for animals
378 Section 2 Effective date
379 This bill takes effect on July I 2014
Legislative Review Note as of 2-4-14 1243 PM
Office of Legislative Research and General Counsel
- 13 shy
LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t
t 02-05-14 122PM t
1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG
2 AMENDMENTS
3 2014 GENERAL SESSION
4 STATE OF UTAH
5 Chief Sponsor Stewart Barlow
6 Senate Sponsor
7
8 LONG TITLE
9 General Description
10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from
11 its licensing requirements under certain circumstances
12 Highlighted Provisions
13 This bill
14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy
15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an
16 employer sponsored clinic and complies with other requirements
17 repeals subject to sunset review the provisions of this bill relating to the exemption
18 described above and
19 ~ makes technical and conforming changes
20 Money Appropriated in this Bill
21 None
22 Other Special Clauses
23 None
24 Utah Code Sections Affected
25 AMENDS
26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~
27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull
1111111111111111111111111111111111111111
HBI06 02-05-14 122 PM
28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278
29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234
30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351
31 ENACTS
32 58-17b-3097 Utah Code Annotated 1953
33
34 Be it enacted by the Legislature ofthe state ofUtah
35 Section 1 Section 58-17b-301 is amended to read
36 58-17b-301 License required -- License classifications for individuals
37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the
38 practice of a pharmacy technician except as specifically provided in Section 58-1-307
39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097
40 (2) The division shall issue to an individual who qualifies under this chapter a license
41 in the classification of
42 (a) pharmacist
43 (b) pharmacy intern or
44 (c) pharmacy technician
45 Section 2 Section 58-17b-302 is amended to read
46 58-17b-302 License required -- License classifications for pharmacy facilities
47 (l) A license is required to act as a pharmacy except as specifically exempted from
48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or
49
50 (2) The division shall issue a pharmacy license to a facility that qualifies under this
51 chapter in the classification of a
52 (a) class A pharmacy
53 (b) class B pharmacy
54 (c) class C pharmacy
55 (d) class D pharmacy or
56 (e) class E pharmacy
57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist
58 at the same address a separate license shall be required for each pharmacy
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02-05-14 122 PM HBI06
59 (4) The division may further define or supplement the classifications of pharmacies
60 The division may impose restrictions upon classifications to protect the public health safety
61 and welfare
62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by
63 rule
64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy
65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities
66 of the pharmacy regardless of the form of the business organization
67 Section 3 Section 58-17b-309 is amended to read
68 58-17b-309 Exemptions from licensure
69 (l) [For ptnp05C5 of] As used in this section
70 (a) Cosmetic drug
71 (i) means a prescription drug that is
72 (A) for the purpose of promoting attractiveness or altering the appearance of an
73 individual and
74 (8) listed as a cosmetic drug subject to the exemption under this section by the division
75 by administrative rule or has been expressly approved for online dispensing whether or not it is
76 dispensed online or through a physicians office and
77 (ii) does not include a prescription drug that is
78 (A) a controlled substance
79 (8) compounded by the physician or
80 (C) prescribed or used for the patient for the purpose of diagnosing curing or
81 preventing a disease
82 (b) Injectable weight loss drug
83 (i) means an injectable prescription drug
84 (A) prescribed to promote weight loss and
85 (8) listed as an injectable prescription drug subject to exemption under this section by
86 the division by administrative rule and
87 (ii) does not include a prescription drug that is a controlled substance
88 (c) Prescribing practitioner means an individual licensed under
89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with
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HB106 02-05-14 122 PM
90 prescriptive practice
91 (ii) Chapter 67 Utah Medical Practice Act
92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or
93 (iv) Chapter 70a Physician Assistant Act
94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l
95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the
96 acts or practices described in this section without being licensed under this chapter
97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the
98 individual notifies the division in writing of the individuals intent to dispense a drug under this
99 [snbsectioll] Subsection (2)
100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1
101 (c) an individual engaging in the practice of pharmacy technician under the direct
102 personal supervision of a pharmacist while making satisfactory progress in an approved
103 program as defined in division rule
104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an
105 injectable weight loss drug to the prescribing practitioners patient in accordance with
106 Subsection (4) or
107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists
108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic
109 drug to the optometrists patient in accordance with Subsection (4)
110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under
111 Subsection (2)( c) must take all examinations as required by division rule following completion
112 of an approved curriculum of education within the required time frame This exemption
113 expires immediately upon notification of a failing score of an examination and the individual
114 may not continue working as a pharmacy technician even under direct supervision
115 (4) A prescribing practitioner or optometrist is exempt from licensing under the
116 provisions of this part if the prescribing practitioner or optometrist
117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the
118 authority to dispense under Subsection (4)(b) and
119 (ii) informs the patient
120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing
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HB106 02-05-14 122 PM
152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the
153 prescribing practitioners or optometrists office and determine if the provisions of this section
154 are being met by the prescribing practitioner or optometrist
155 (d) If a prescribing practitioner or optometrist violates a provision of this section the
156 prescribing practitioner or optometrist may be subject to discipline under
157 (i) this chapter and
158 (ii) (A) Chapter 16a Utah Optometry Practice Act
159 (B) Chapter 31 b Nurse Practice Act
160 (C) Chapter 67 Utah Medical Practice Act
161 (D) Chapter 68 Utah Osteopathic Medical Practice Act
162 (E) Chapter 70a Physician Assistant Act or
163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act
164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the
165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah
166 Optometry Practice Act
167 Section 4 Section 58-17b-3095 is amended to read
168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy
169 Division study of dispensing practitioners
170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen
171 (a) means a prescription drug used to treat cancer manage its symptoms or provide
172 continuity of care for a cancer patient
173 (b) includes
174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal
175 methods and
176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize
177 physical and psychological symptoms or pain or to improve patient tolerance of cancer
178 treatments or prepare a patient for a subsequent course of therapy and
179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug
180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections
181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt
182 from licensure under this chapter
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HB106 02-05-14 122 PM
214 (ii) is acting under the direction of a prescribing practitioner who is immediately
215 available on site for any necessary consultation and who has complied with Subsection
216 (2)(b)(i)
217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the
218 outpatient clinic setting and
219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)
220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to
221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section
222 (b) The evaluation under this Subsection (3) shall include
223 (i) practitioner compliance with the requirements of this section and Section
224 58-l7b-309
225 (ii) current research on dispensing and patient safety
226 (iii) survey of other state dispensing laws and
227 (iv) recommendations for future action concerning practitioner dispensing
228 (c) The division shall report to the Legislatures Health and Human Services Interim
229 Committee by November 302012 and by November 302013 with the results and
230 recommendations from the evaluation required by this Subsection (3)
231 (4) This section sunsets in accordance with Section 631-1-258
232 Section 5 Section 58-17b-3097 is enacted to read
233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an
234 employer sponsored clinic
235 (1) As used in this section
236 (a) Employer sponsored clinic means an entity that offers health care only to the
237 employees of an exclusive group of employers and the employees dependents
238 (b) Health care is as defined in Section 31 A-J-301
239 (c) Prepackaged drug means a prescription drug that
240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and
241 (ii) is packaged in a fixed quantity per package by
242 (A) the drug manufacturer
243 (B) a pharmaceutical wholesaler or distributor or
244 (C) a pharmacy licensed under this title
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02-05-14 122 PM HB106
245 Cd) Prescribing practitioner is as defined in Section 58-17b-309
246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309
247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing
248 requirements of this chapter if the prescribing practitioner
249 Ca) treats an employee of one of an exclusive group of employers at an employer
250 sponsored clinic
251 Cb) prescribes a prepackaged drug to the employee
252 Cc) dispenses the prepackaged drug at the employer sponsored clinic
253 (d) notifies the division
254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the
255 employer sponsored clinic and
256 (ii) of the drug the prescribing practitioner intends to dispense
257 Ce) determines that providing the prepackaged drug to the employee at the employer
258 sponsored clinic is in the employees best interest
259 (f) informs the employee
260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner
261 from a pharmacy that is unaffiliated with the prescribing practitioner
262 (ii) of the directions for appropriate use of the prepackaged drug
263 (iii) of potential side effects to the use of the prepackaged drug and
264 (iv) how to contact the prescribing practitioner if the employee has questions or
265 concerns regarding the drug
266 (g) offers the employee the opportunity to consult with a pharmacist if the employee
267 asks for patient counseling and
268 (h) follows the administrative rules for a prescribing practitioner at an employer
269 sponsored clinic established by the division under Subsection (4)
270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a
271 prepackaged drug under this section requires physician supervision in its scope ofpractice
272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the
273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter
274 68 Utah Osteopathic Medical Practice Act
275 (4) The division shall in consultation with the board of pharmacy and the Physicians
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HBI06 02-05-14 122 PM
276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title
277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping
278 patient counseling purchasing and distribution operating treatment quality of care and
279 storage requirements for a prescribing practitioner at an employer sponsored clinic
280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a
281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing
282 practitioner is in compliance with this section
283 (6) If a prescribing practitioner violates a provision of this section the prescribing
284 practitioner may be subject to discipline under
285 (a) this chapter and
286 (b) any other chapter that governs the terms of the prescribing practitioners license
287 (7) The division shall evaluate the exemption created by this section and report to the
288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1
289 2018 on the results of the evaluation and the divisions recommendations regarding the
290 exemption
291 Section 6 Section 631-1-258 is amended to read
292 631-1-258 Repeal dates Title 58
293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is
294 repealed July 12016
295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015
296 (3) Section 58-17b-3095 is repealed July 1 2015
297 (4) Section 58-17b-3097 is repealed on July 12018
298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1
299 2018
300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1
301 2023
302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing
303 Act is repealed July 1 2019
304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1
305 2015
306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is
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02-05-14 1 22 PM HB106
307 repealed July 12023
308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1
309 2014
310 [ttej] ill) Section 58-69-3025 is repealed on July 12015
311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017
Legislative Review Note as of 2-3-14 418 PM
Office of Legislative Research and General Counsel
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02-05-14 156 PM SB178
59 (A) fit within the responsibilities of the Department of Health for health and welfare
60 (B) are reviewed and approved by an Institutional Review Board that is approved for
61 human subject research by the United States Department of Health and Human Services and
62 (C) are not conducted for profit or commercial gain and
63 (D) are conducted in a research facility as defined by division rule that is associated
64 with a university or college in the state accredited by the Northwest Commission on Colleges
65 and Universities
66 (iii) the designee protects the information as a business associate of the Department of
67 Health and
68 (iv) the identity of the prescribers patients and pharmacies in the database are
69 de-identified confidential not disclosed in any manner to the designee or to any individual
70 who is not directly involved in the scientific studies
71 (e) a licensed practitioner having authority to prescribe controlled substances to the
72 extent the information
73 (i) (A) relates specifically to a current or prospective patient of the practitioner and
74 (B) is provided to or sought by the practitioner for the purpose of
75 (I) prescribing or considering prescribing any controlled substance to the current or
76 prospective patient
77 (II) diagnosing the current or prospective patient
78 (nn providing medical treatment or medical advice to the current or prospective
79 patient or
80 (IV) determining whether the current or prospective patient
81 (Aa) is attempting to fraudulently obtain a controlled substance from the practitioner
82 or
83 (Bb) has fraudulently obtained or attempted to fraudulently obtain a controlled
84 substance from the practitioner
85 (ii) (A) relates specifically to a fonner patient of the practitioner and
86 (B) is provided to or sought by the practitioner for the purpose of determining whether
87 the former patient has fraudulently obtained or has attempted to fraudulently obtain a
88 controlled substance from the practitioner
89 (iii) relates specifically to an individual who has access to the practitioners Drug
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02-05-14 156 PM SB178
121 58-3 7f-203(3 )(b) with respect to the employee
122 (h) a licensed pharmacist having authority to dispense a controlled substance to the
123 extent the information is provided or sought for the purpose of
124 (i) dispensing or considering dispensing any controlled substance or
125 (ii) determining whether a person
126 (A) is attempting to fraudulently obtain a controlled substance from the pharmacist or
127 (B) has fraudulently obtained or attempted to fraudulently obtain a controlled
128 substance from the pharmacist
129 (i) in accordance with Subsection (3)(a) a licensed pharmacy technician who is an
]30 employee of a pharmacy as defined in Section 58-17b-l 02 for the purposes described in
131 Subsection (2)(h)(i) or (iO if
132 0) the employee is designated by the pharmacist-in-charge as an individual authorized
133 to access the information on behalf of a licensed pharmacist employed by the pharmacy
134 (ii) the pharmacist-in-charge provides written notice to the division of the identity of
135 the employee and
136 (iii) the division
137 CA) grants the employee access to the database and
138 (B) provides the employee with a password that is unique to that employee to access
139 the database in order to permit the division to comply with the requirements of Subsection
140 58-37f-203(3)(b) with respect to the employee
141 [fiJ] ill federal state and local law enforcement authorities and state and local
142 prosecutors engaged as a specified duty of their employment in enforcing laws
143 (i) regulating controlled substances
144 (ii) investigating insurance fraud Medicaid fraud or Medicare fraud or
145 (iii) providing information about a criminal defendant to defense counsel upon request
146 during the discovery process for the purpose of establishing a defense in a criminal case
147 [61] fhl employees ofthe Office oflntemal Audit and Program Integrity within the
148 Department of Health who are engaged in their specified duty of ensuring Medicaid program
149 integrity under Section 26-18-23
150 [fki] ill a mental health therapist if
151 (i) the information relates to a patient who is
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02-05-14 156 PM SB178
183 designated under Subsection (2)(f) (2)(g) or (4)(c) should be granted access to the database
184 and
185 (ii) establish the information to be provided by an emergency room employee under
186 Subsection (4)
187 (c) The division shall grant an employee designated under Subsection (2)(f) (2)(g) or
188 (4)( c) access to the database unless the division determines based on a background check that
189 the employee poses a security risk to the information contained in the database
190 (4) (a) An individual who is employed in the emergency room ofa hospital may
191 exercise access to the database under this Subsection (4) on behalf of a licensed practitioner if
192 the individual is designated under Subsection (4)( c) and the licensed practitioner
193 (i) is employed in the emergency room
194 Oi) is treating an emergency room patient for an emergency medical condition and
195 (iii) requests that an individual employed in the emergency room and designated under
196 Subsection (4)( c) obtain information regarding the patient from the database as needed in the
197 course of treatment
198 (b) The emergency room employee obtaining information from the database shall
199 when gaining access to the database provide to the database the name and any additional
200 identifiers regarding the requesting practitioner as required by division administrative rule
201 established under Subsection (3)(b)
202 (c) An individual employed in the emergency room under this Subsection (4) may
203 obtain information from the database as provided in Subsection (4)(a) if
204 (i) the employee is designated by the practitioner as an individual authorized to access
205 the information on behalf of the practitioner
206 (ii) the practitioner and the hospital operating the emergency room provide written
207 notice to the division of the identity of the designated employee and
208 (iii) the division
209 (A) grants the employee access to the database and
210 (B) provides the employee with a password that is unique to that employee to access
211 the database in order to permit the division to comply with the requirements of Subsection
212 58-37f-203(3)(b) with respect to the employee
213 (d) The division may impose a fee in accordance with Section 63J-I-504 on a
- 7
LEGISLATIVE GENERAL C01JNSEL SB55 iL Approved for Filing Cl Dupont iL lst Sub (Green)
iL 02-07-14 416 PM iL
Senator Evan J Vickers proposes the following substitute bill
PHARMACEUTICAL DISPENSING AMENDMENTS
2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Evan J Vickers
5 House Sponsor Stewart Barlow
6
7 LONG TITLE
8 General Description
9 This bill amends the Pharmacy Practice Act to create a dispensing medical practitioner
10 license and a license classification for a dispensing medical practitioner clinic
11 pharmacy
12 Highlighted Provisions
13 This bill
14 defines terms
15 establishes the license classification dispensing medical practitioner under the
16 Pharmacy Practice Act for medical practitioners who prescribe and dispense a drug
17 establishes the pharmacy facility license classification dispensing medical
18 practitioner clinic pharmacy under the Pharmacy Practice Act
19 creates Part 8 Dispensing Medical Practitioner and Dispensing Medical Practitioner
20 Clinic Pharmacy
21 removes the exemption from the Pharmacy Practice Act for medical practitioners
22 who prescribe and dispense a cosmetic drug injectable weight loss drug or a cancer
23 drug treatment regimen
24 requires a license as a dispensing medical practitioner for a health care practitioner 00
25 to dispense bull bull=
1111111111111111111111111111111111111111111111111111111
02-07-14 416 PM 1st Sub (Green) SB 55
615 Practitioner Clinic Pharmacy II
616 Section 8 Section 58-17b-802 is enacted to read
617 58-17b-802 Definitions
618 As used in this part
619 (1) (a) Cosmetic drug means a prescription drug that
620 (i) is for the purpose of promoting attractiveness or altering the appearance of an
621 individual and
622 (ii) (A) is listed as a cosmetic drug subject to the exemption under this section by the
623 division by administrative rule or
624 CB) has been expressly approved for online dispensing whether or not it is dispensed
625 online or through a physicians office
626 (b) Cosmetic drug does not include a prescription drug that is
627 (i) a controlled substance
628 (ii) compounded by the physician or
629 (iii) prescribed or used for the patient for the purpose of diagnosing curing or
630 preventing a disease
631 (2) Employer sponsored clinic means an entity that S-t has a medical director who is
631 a licensed as a physician as defined in Section 58-67-102 and S offers health care only to the
632 employees of an exclusive group of employers and the employees dependents
633 (3) Health care is as defined in Section 31A-1-301
634 (4) Ca) Injectable weight loss drug means an injectable prescription drug
635 (n prescribed to promote weight loss and
636 (ii) listed as an injectable prescription drug subject to exemption under this section by
637 the division by administrative rule
638 (b) Injectable weight loss drug does not include a prescription drug that is a
639 controlled substance
640 (5) Prepackaged drug means a prescription drug that
641 (a) is not listed under federal or state law as a Schedule I II ill IV or V drug and
642 (b) is packaged in a fixed quantity per package by
643 (i) the drug manufacturer
644 (ii) a pharmaceutical wholesaler or distributor or
645 (iii) a pharmacy licensed under this title
- 21 Senate Committee Amendments 2-13-2014 Jplcjd
1st Sub (Green) SB 55 02-07-14 416 PM
646 Section 9 Section 58-17b-803 is enacted to read
647 58-17b-803 Qualifications for licensure as a dispensing medical practitioner -shy
648 Scope of practice
649 (1) An applicant for a license as a dispensing medical practitioner shall
650 (a) be licensed in good standing under at least one of the chapters listed in Subsection
651 58-17b-l02(23)(a) and
652 (b) submit an application for a license as a dispensing medical practitioner in a form
653 prescribed by the division and pay a fee established by the S [depal tment] divisionS ~
654 (2) The division shall accept the licensing in good standing under Subsection (1) in lieu
655 of requiring an applicant for a license under this part to comply with Sections 58-17b-303 and
656
657 (3) A dispensing medical practitioner may dispense in accordance with this part
658 (a) a cosmetic drug and an injectable weight loss drug if
659 (i) the drug was prescribed by the dispensing medical practitioner to the dispensing
660 medical practitioners patient and
661 Oi) the dispensing medical practitioner complies with administrative rules adopted by
662 the division under Subsection 58-17-802(1)
663 (b) a cancer drug treatment regimen if the dispensing medical practitioner complies
664 with Section 58-17b-805 and
665 (c) a pre-packaged drug to an employee or a dependent of an employee at an employer
666 sponsored clinic if the dispensing medical practitioner
667 (i) treats an employee or the dependent of an employee of one of an exclusive group
668 of employers at an employer sponsored clinic
669 (ii) prescribes a prepackaged drug to the employee or the employees dependent
670 (iii) dispenses the prepackaged drug at the employer sponsored clinic and
671 (iv) complies with administrative rules adopted by the division in consultation with the
672 Board of Pharmacy that establish labeling record keeping patient counseling purchasing and
673 distribution operating treatment quality of care and storage requirements
674 (4) A dispensing medical practitioner
675 Ca) shall inform the patient
676 (i) that the drug dispensed by the practitioner may be obtained from a pharmacy
- 22 - Senate Committee Amendments 2-13-2014 picjd
02-07-14 416 PM 1st Sub (Green) SB 55
739 58-17b-806 Dispensing medical practitioner -- Dispensing medical practitioner
740 clinic pharmacy -- Unprofessional and Unlawful conduct
741 ill S Ull S The division S [ iii consultation witb tile boal d shall
742 (a) I epol t a violation of this chapter b a dispensing medical pi actitiollel to] shall consult
742a with S the
743 dispensing medical practitioners appropriate licensing board as designated in Subsection
744 5S-17b-l02(23)(a) S reeardine a violation oftMs chapterS and
745 (hl S the Pharmacy Board shall if requested by the licensine board of the dispensine
745a medical practitionerS assist the licensing board for the dispensing medical practitioner with
745b reviewing the
746 violations of the provisions of this chapter
747 (2) The division S [ in collabOi atioll with the Boal d ofPhall1l3C]S may take
747a appropriate
748 action against a dispensing medical practitioner in accordance with this chapter if the
749 licensing board designated in Subsection 58-17b- 02(23)(a) recommends to the division that
750 action be taken under this chapter
751 (3) The division in consultation with the board is the primary enforcer under this
752 chapter for a dispensing medical practitioner clinic pharmacy licensed under Section
753 58-17b-804
754 Section 13 Section 58-31b-502 is amended to read
755 58-31b-502 Unprofessional conduct
756 Unprofessional conduct includes
757 (l) failure to safeguard a patients right to privacy as to the patients person condition
758 diagnosis personal effects or any other matter about which the licensee is privileged to know
759 because of the licensees or person with a certifications position or practice as a nurse or
760 practice as a medication aide certified
761 (2) failure to provide nursing service or service as a medication aide certified in a
762 manner that demonstrates respect for the patients human dignity and unique personal character
763 and needs without regard to the patients race religion ethnic background socioeconomic
764 status age sex or the nature of the patients health problem
765 (3) engaging in sexual relations with a patient during any
766 (a) period when a generally recognized professional relationship exists between the
767 person licensed or certified under this chapter and patient or
768 (b) extended period when a patient has reasonable cause to believe a professional
769 relationship exists between the person licensed or certified under the provisions of this chapter
- 25 - Senate Committee Amendments 2-13-2014Iplcjd
LEGISLA TIVE GENERAL COUNSEL SB138 ct Approved for Filing Sc Allred ct
ct 02-04-14 1220 PM ct
1 CONTROLLED SUBSTANCES ACT AMENDMENTS
2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Evan J Vickers
5 House Sponsor Stewart Barlow
6
7 LONG TITLE
8 General Description
9 This bill modifies the Utah Controlled Substances Act regarding prescriptions for
10 controlled substances
11 Highlighted Provisions
12 This bill
13 ~ provides that more than one controlled substance may be included in a prescription
14 Money Appropriated in this Bill
15 None
16 Other Special Clauses
17 None
18 Utah Code Sections Affected
19 AMENDS
20 58-37-6 as last amended by Laws of Utah 2012 Chapter 272
21
22 Be it enacted by the Legislature of the state ofUtah
23 Section 1 Section 58-37-6 is amended to read
24 58-37-6 License to manufacture produce distribute dispense administer or
25 conduct research -- Issuance by division -- Denial suspension or revocation -- Records
26
27
required -- Prescriptions
(1) (a) The division may adopt rules relating to the licensing and control of the bull
1111111111111111111111111111111111111111
SB138 02-04-14 1220 PM
214 (ii) the prescribed controlled substance is to be used in research
215 (f) Except when administered directly to an ultimate user by a licensed practitioner
216 controlled substances are subject to the following restrictions
217 (i) (A) A prescription for a Schedule IT substance may not be refilled
218 (B) A Schedule II controlled substance may not be filled in a quantity to exceed a
219 one-months supply as directed on the daily dosage rate of the prescriptions
220 (ii) A Schedule ill or IV controlled substance may be filled only within six months of
221 issuance and may not be refilled more than six months after the date of its original issuance or
222 be refilled more than five times after the date of the prescription unless renewed by the
223 practitioner
224 (iii) All other controlled substances in Schedule V may be refilled as the prescribers
225 prescription directs but they may not be refilled one year after the date the prescription was
226 issued unless renewed by the practitioner
227 (iv) Any prescription for a Schedule IT substance may not be dispensed if it is not
228 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days
229 after the date the prescription was issued or 30 days after the dispensing date if that date is
230 specified separately from the date of issue
231 (v) A practitioner may issue more than one prescription at the same time for the same
232 Schedule IT controlled substance but only under the following conditions
233 (A) no more than three prescriptions for the same Schedule IT controlled substance may
234 be issued at the same time
235 (B) no one prescription may exceed a 30-day supply
236 (C) a second or third prescription shall include the date of issuance and the date for
237 dispensing and
238 (D) unless the practitioner determines there is a valid medical reason to the contrary
239 the date for dispensing a second or third prescription may not be fewer than 30 days from the
240 dispensing date of the previous prescription
241 [(1i) Each prescription rot a controlled snbstance may eontain only one controlled
242 substance per pIescription frlim and may not contain any other legend dmg 01 prescription
243 item]
244 (g) An order for a controlled substance in Schedules IT through V for use by an
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LEGISLATIVE GENERAL COUNSEL it Approved for Filing CJ Dupont it
HB114
it 02-06-14855 AM it
1 MAIL-ORDER WHOLESALE DRUG AMENDMENTS 2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Stewart Barlow
5 Senate Sponsor ______
6
7 LONG TITLE
8 General Description
9 This bill amends the Pharmacy Practice Act
10 Highlighted Provisions
11 This bill
12 ~ amends the definition of a class C pharmacy subject to regulation under the
13 Pharmacy Practice Act
14 Money Appropriated in this Bill
15 None
16 Other Special Clauses
17 This bi II takes effect on July 1 2014
18 Utah Code Sections Affected
19 AMENDS
20 58-17b-102 as last amended by Laws of Utah 2013 Chapters 52 166 and 423
21
22 Be it enacted by the Legislature ofthe state ofUtah
23 Section 1 Section 58-17b-102 is amended to read
24 58-17b-102 Definitions
25 In addition to the definitions in Section 58-1-102 as used in this chapter
26
27
(1) Administering means
(a) the direct application of a prescription drug or device whether by injection
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59 (9) Centralized prescription processing means the processing by a pharmacy of a
60 request from another pharmacy to fill or refill a prescription drug order or to perform
61 processing functions such as dispensing drug utilization review claims adjudication refill
62 authorizations and therapeutic interventions
63 (10) Class A pharmacy means a pharmacy located in Utah that is authorized as a
64 retail pharmacy to compound or dispense a drug or dispense a device to the public under a
65 prescription order
66 (11) Class B pharmacy
67 (a) means a pharmacy located in Utah
68 (i) that is authorized to provide pharmaceutical care for patients in an institutional
69 setting and
70 (ii) whose primary purpose is to provide a physical environment for patients to obtain
71 health care services and
72 (b) (i) includes closed-door hospital clinic nuclear and branch pharmacies and
73 (ii) pharmaceutical administration and sterile product preparation facilities
74 (12) Class C pharmacy means a pharmacy [located ill Utah that is anthOl ized to
75 engage] that engages in the manufacture production wholesale or distribution of drugs or
76 devices in Utah
77 (13) Class D pharmacy means a nonresident pharmacy
78 (14) Class E pharmacy means all other pharmacies
79 (15) Closed-door pharmacy means a pharmacy that provides pharmaceutical care to a
80 defined and exclusive group of patients who have access to the services of the pharmacy
81 because they are treated by or have an affiliation with a specific entity including a health
82 maintenance organization or an infusion company but not including a hospital pharmacy a
83 retailer of goods to the general public or the office of a practitioner
84 (16) Collaborative pharmacy practice means a practice of pharmacy whereby one or
85 more pharmacists have jointly agreed on a voluntary basis to work in conjunction with one or
86 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical
87 care functions authorized by the practitioner or practitioners under certain specified conditions
88 or limitations
89 (17) Collaborative pharmacy practice agreement means a written and signed
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02-06-14855 AM HB114
369 and
370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in
371 collaboration with the board
372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501
373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and
374 may be further defined by rule
375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that
376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration
377 for animals
378 Section 2 Effective date
379 This bill takes effect on July I 2014
Legislative Review Note as of 2-4-14 1243 PM
Office of Legislative Research and General Counsel
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LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t
t 02-05-14 122PM t
1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG
2 AMENDMENTS
3 2014 GENERAL SESSION
4 STATE OF UTAH
5 Chief Sponsor Stewart Barlow
6 Senate Sponsor
7
8 LONG TITLE
9 General Description
10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from
11 its licensing requirements under certain circumstances
12 Highlighted Provisions
13 This bill
14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy
15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an
16 employer sponsored clinic and complies with other requirements
17 repeals subject to sunset review the provisions of this bill relating to the exemption
18 described above and
19 ~ makes technical and conforming changes
20 Money Appropriated in this Bill
21 None
22 Other Special Clauses
23 None
24 Utah Code Sections Affected
25 AMENDS
26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~
27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull
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28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278
29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234
30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351
31 ENACTS
32 58-17b-3097 Utah Code Annotated 1953
33
34 Be it enacted by the Legislature ofthe state ofUtah
35 Section 1 Section 58-17b-301 is amended to read
36 58-17b-301 License required -- License classifications for individuals
37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the
38 practice of a pharmacy technician except as specifically provided in Section 58-1-307
39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097
40 (2) The division shall issue to an individual who qualifies under this chapter a license
41 in the classification of
42 (a) pharmacist
43 (b) pharmacy intern or
44 (c) pharmacy technician
45 Section 2 Section 58-17b-302 is amended to read
46 58-17b-302 License required -- License classifications for pharmacy facilities
47 (l) A license is required to act as a pharmacy except as specifically exempted from
48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or
49
50 (2) The division shall issue a pharmacy license to a facility that qualifies under this
51 chapter in the classification of a
52 (a) class A pharmacy
53 (b) class B pharmacy
54 (c) class C pharmacy
55 (d) class D pharmacy or
56 (e) class E pharmacy
57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist
58 at the same address a separate license shall be required for each pharmacy
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59 (4) The division may further define or supplement the classifications of pharmacies
60 The division may impose restrictions upon classifications to protect the public health safety
61 and welfare
62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by
63 rule
64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy
65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities
66 of the pharmacy regardless of the form of the business organization
67 Section 3 Section 58-17b-309 is amended to read
68 58-17b-309 Exemptions from licensure
69 (l) [For ptnp05C5 of] As used in this section
70 (a) Cosmetic drug
71 (i) means a prescription drug that is
72 (A) for the purpose of promoting attractiveness or altering the appearance of an
73 individual and
74 (8) listed as a cosmetic drug subject to the exemption under this section by the division
75 by administrative rule or has been expressly approved for online dispensing whether or not it is
76 dispensed online or through a physicians office and
77 (ii) does not include a prescription drug that is
78 (A) a controlled substance
79 (8) compounded by the physician or
80 (C) prescribed or used for the patient for the purpose of diagnosing curing or
81 preventing a disease
82 (b) Injectable weight loss drug
83 (i) means an injectable prescription drug
84 (A) prescribed to promote weight loss and
85 (8) listed as an injectable prescription drug subject to exemption under this section by
86 the division by administrative rule and
87 (ii) does not include a prescription drug that is a controlled substance
88 (c) Prescribing practitioner means an individual licensed under
89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with
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90 prescriptive practice
91 (ii) Chapter 67 Utah Medical Practice Act
92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or
93 (iv) Chapter 70a Physician Assistant Act
94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l
95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the
96 acts or practices described in this section without being licensed under this chapter
97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the
98 individual notifies the division in writing of the individuals intent to dispense a drug under this
99 [snbsectioll] Subsection (2)
100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1
101 (c) an individual engaging in the practice of pharmacy technician under the direct
102 personal supervision of a pharmacist while making satisfactory progress in an approved
103 program as defined in division rule
104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an
105 injectable weight loss drug to the prescribing practitioners patient in accordance with
106 Subsection (4) or
107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists
108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic
109 drug to the optometrists patient in accordance with Subsection (4)
110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under
111 Subsection (2)( c) must take all examinations as required by division rule following completion
112 of an approved curriculum of education within the required time frame This exemption
113 expires immediately upon notification of a failing score of an examination and the individual
114 may not continue working as a pharmacy technician even under direct supervision
115 (4) A prescribing practitioner or optometrist is exempt from licensing under the
116 provisions of this part if the prescribing practitioner or optometrist
117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the
118 authority to dispense under Subsection (4)(b) and
119 (ii) informs the patient
120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing
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152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the
153 prescribing practitioners or optometrists office and determine if the provisions of this section
154 are being met by the prescribing practitioner or optometrist
155 (d) If a prescribing practitioner or optometrist violates a provision of this section the
156 prescribing practitioner or optometrist may be subject to discipline under
157 (i) this chapter and
158 (ii) (A) Chapter 16a Utah Optometry Practice Act
159 (B) Chapter 31 b Nurse Practice Act
160 (C) Chapter 67 Utah Medical Practice Act
161 (D) Chapter 68 Utah Osteopathic Medical Practice Act
162 (E) Chapter 70a Physician Assistant Act or
163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act
164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the
165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah
166 Optometry Practice Act
167 Section 4 Section 58-17b-3095 is amended to read
168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy
169 Division study of dispensing practitioners
170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen
171 (a) means a prescription drug used to treat cancer manage its symptoms or provide
172 continuity of care for a cancer patient
173 (b) includes
174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal
175 methods and
176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize
177 physical and psychological symptoms or pain or to improve patient tolerance of cancer
178 treatments or prepare a patient for a subsequent course of therapy and
179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug
180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections
181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt
182 from licensure under this chapter
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214 (ii) is acting under the direction of a prescribing practitioner who is immediately
215 available on site for any necessary consultation and who has complied with Subsection
216 (2)(b)(i)
217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the
218 outpatient clinic setting and
219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)
220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to
221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section
222 (b) The evaluation under this Subsection (3) shall include
223 (i) practitioner compliance with the requirements of this section and Section
224 58-l7b-309
225 (ii) current research on dispensing and patient safety
226 (iii) survey of other state dispensing laws and
227 (iv) recommendations for future action concerning practitioner dispensing
228 (c) The division shall report to the Legislatures Health and Human Services Interim
229 Committee by November 302012 and by November 302013 with the results and
230 recommendations from the evaluation required by this Subsection (3)
231 (4) This section sunsets in accordance with Section 631-1-258
232 Section 5 Section 58-17b-3097 is enacted to read
233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an
234 employer sponsored clinic
235 (1) As used in this section
236 (a) Employer sponsored clinic means an entity that offers health care only to the
237 employees of an exclusive group of employers and the employees dependents
238 (b) Health care is as defined in Section 31 A-J-301
239 (c) Prepackaged drug means a prescription drug that
240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and
241 (ii) is packaged in a fixed quantity per package by
242 (A) the drug manufacturer
243 (B) a pharmaceutical wholesaler or distributor or
244 (C) a pharmacy licensed under this title
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245 Cd) Prescribing practitioner is as defined in Section 58-17b-309
246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309
247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing
248 requirements of this chapter if the prescribing practitioner
249 Ca) treats an employee of one of an exclusive group of employers at an employer
250 sponsored clinic
251 Cb) prescribes a prepackaged drug to the employee
252 Cc) dispenses the prepackaged drug at the employer sponsored clinic
253 (d) notifies the division
254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the
255 employer sponsored clinic and
256 (ii) of the drug the prescribing practitioner intends to dispense
257 Ce) determines that providing the prepackaged drug to the employee at the employer
258 sponsored clinic is in the employees best interest
259 (f) informs the employee
260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner
261 from a pharmacy that is unaffiliated with the prescribing practitioner
262 (ii) of the directions for appropriate use of the prepackaged drug
263 (iii) of potential side effects to the use of the prepackaged drug and
264 (iv) how to contact the prescribing practitioner if the employee has questions or
265 concerns regarding the drug
266 (g) offers the employee the opportunity to consult with a pharmacist if the employee
267 asks for patient counseling and
268 (h) follows the administrative rules for a prescribing practitioner at an employer
269 sponsored clinic established by the division under Subsection (4)
270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a
271 prepackaged drug under this section requires physician supervision in its scope ofpractice
272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the
273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter
274 68 Utah Osteopathic Medical Practice Act
275 (4) The division shall in consultation with the board of pharmacy and the Physicians
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276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title
277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping
278 patient counseling purchasing and distribution operating treatment quality of care and
279 storage requirements for a prescribing practitioner at an employer sponsored clinic
280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a
281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing
282 practitioner is in compliance with this section
283 (6) If a prescribing practitioner violates a provision of this section the prescribing
284 practitioner may be subject to discipline under
285 (a) this chapter and
286 (b) any other chapter that governs the terms of the prescribing practitioners license
287 (7) The division shall evaluate the exemption created by this section and report to the
288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1
289 2018 on the results of the evaluation and the divisions recommendations regarding the
290 exemption
291 Section 6 Section 631-1-258 is amended to read
292 631-1-258 Repeal dates Title 58
293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is
294 repealed July 12016
295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015
296 (3) Section 58-17b-3095 is repealed July 1 2015
297 (4) Section 58-17b-3097 is repealed on July 12018
298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1
299 2018
300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1
301 2023
302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing
303 Act is repealed July 1 2019
304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1
305 2015
306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is
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307 repealed July 12023
308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1
309 2014
310 [ttej] ill) Section 58-69-3025 is repealed on July 12015
311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017
Legislative Review Note as of 2-3-14 418 PM
Office of Legislative Research and General Counsel
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121 58-3 7f-203(3 )(b) with respect to the employee
122 (h) a licensed pharmacist having authority to dispense a controlled substance to the
123 extent the information is provided or sought for the purpose of
124 (i) dispensing or considering dispensing any controlled substance or
125 (ii) determining whether a person
126 (A) is attempting to fraudulently obtain a controlled substance from the pharmacist or
127 (B) has fraudulently obtained or attempted to fraudulently obtain a controlled
128 substance from the pharmacist
129 (i) in accordance with Subsection (3)(a) a licensed pharmacy technician who is an
]30 employee of a pharmacy as defined in Section 58-17b-l 02 for the purposes described in
131 Subsection (2)(h)(i) or (iO if
132 0) the employee is designated by the pharmacist-in-charge as an individual authorized
133 to access the information on behalf of a licensed pharmacist employed by the pharmacy
134 (ii) the pharmacist-in-charge provides written notice to the division of the identity of
135 the employee and
136 (iii) the division
137 CA) grants the employee access to the database and
138 (B) provides the employee with a password that is unique to that employee to access
139 the database in order to permit the division to comply with the requirements of Subsection
140 58-37f-203(3)(b) with respect to the employee
141 [fiJ] ill federal state and local law enforcement authorities and state and local
142 prosecutors engaged as a specified duty of their employment in enforcing laws
143 (i) regulating controlled substances
144 (ii) investigating insurance fraud Medicaid fraud or Medicare fraud or
145 (iii) providing information about a criminal defendant to defense counsel upon request
146 during the discovery process for the purpose of establishing a defense in a criminal case
147 [61] fhl employees ofthe Office oflntemal Audit and Program Integrity within the
148 Department of Health who are engaged in their specified duty of ensuring Medicaid program
149 integrity under Section 26-18-23
150 [fki] ill a mental health therapist if
151 (i) the information relates to a patient who is
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183 designated under Subsection (2)(f) (2)(g) or (4)(c) should be granted access to the database
184 and
185 (ii) establish the information to be provided by an emergency room employee under
186 Subsection (4)
187 (c) The division shall grant an employee designated under Subsection (2)(f) (2)(g) or
188 (4)( c) access to the database unless the division determines based on a background check that
189 the employee poses a security risk to the information contained in the database
190 (4) (a) An individual who is employed in the emergency room ofa hospital may
191 exercise access to the database under this Subsection (4) on behalf of a licensed practitioner if
192 the individual is designated under Subsection (4)( c) and the licensed practitioner
193 (i) is employed in the emergency room
194 Oi) is treating an emergency room patient for an emergency medical condition and
195 (iii) requests that an individual employed in the emergency room and designated under
196 Subsection (4)( c) obtain information regarding the patient from the database as needed in the
197 course of treatment
198 (b) The emergency room employee obtaining information from the database shall
199 when gaining access to the database provide to the database the name and any additional
200 identifiers regarding the requesting practitioner as required by division administrative rule
201 established under Subsection (3)(b)
202 (c) An individual employed in the emergency room under this Subsection (4) may
203 obtain information from the database as provided in Subsection (4)(a) if
204 (i) the employee is designated by the practitioner as an individual authorized to access
205 the information on behalf of the practitioner
206 (ii) the practitioner and the hospital operating the emergency room provide written
207 notice to the division of the identity of the designated employee and
208 (iii) the division
209 (A) grants the employee access to the database and
210 (B) provides the employee with a password that is unique to that employee to access
211 the database in order to permit the division to comply with the requirements of Subsection
212 58-37f-203(3)(b) with respect to the employee
213 (d) The division may impose a fee in accordance with Section 63J-I-504 on a
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LEGISLATIVE GENERAL C01JNSEL SB55 iL Approved for Filing Cl Dupont iL lst Sub (Green)
iL 02-07-14 416 PM iL
Senator Evan J Vickers proposes the following substitute bill
PHARMACEUTICAL DISPENSING AMENDMENTS
2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Evan J Vickers
5 House Sponsor Stewart Barlow
6
7 LONG TITLE
8 General Description
9 This bill amends the Pharmacy Practice Act to create a dispensing medical practitioner
10 license and a license classification for a dispensing medical practitioner clinic
11 pharmacy
12 Highlighted Provisions
13 This bill
14 defines terms
15 establishes the license classification dispensing medical practitioner under the
16 Pharmacy Practice Act for medical practitioners who prescribe and dispense a drug
17 establishes the pharmacy facility license classification dispensing medical
18 practitioner clinic pharmacy under the Pharmacy Practice Act
19 creates Part 8 Dispensing Medical Practitioner and Dispensing Medical Practitioner
20 Clinic Pharmacy
21 removes the exemption from the Pharmacy Practice Act for medical practitioners
22 who prescribe and dispense a cosmetic drug injectable weight loss drug or a cancer
23 drug treatment regimen
24 requires a license as a dispensing medical practitioner for a health care practitioner 00
25 to dispense bull bull=
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02-07-14 416 PM 1st Sub (Green) SB 55
615 Practitioner Clinic Pharmacy II
616 Section 8 Section 58-17b-802 is enacted to read
617 58-17b-802 Definitions
618 As used in this part
619 (1) (a) Cosmetic drug means a prescription drug that
620 (i) is for the purpose of promoting attractiveness or altering the appearance of an
621 individual and
622 (ii) (A) is listed as a cosmetic drug subject to the exemption under this section by the
623 division by administrative rule or
624 CB) has been expressly approved for online dispensing whether or not it is dispensed
625 online or through a physicians office
626 (b) Cosmetic drug does not include a prescription drug that is
627 (i) a controlled substance
628 (ii) compounded by the physician or
629 (iii) prescribed or used for the patient for the purpose of diagnosing curing or
630 preventing a disease
631 (2) Employer sponsored clinic means an entity that S-t has a medical director who is
631 a licensed as a physician as defined in Section 58-67-102 and S offers health care only to the
632 employees of an exclusive group of employers and the employees dependents
633 (3) Health care is as defined in Section 31A-1-301
634 (4) Ca) Injectable weight loss drug means an injectable prescription drug
635 (n prescribed to promote weight loss and
636 (ii) listed as an injectable prescription drug subject to exemption under this section by
637 the division by administrative rule
638 (b) Injectable weight loss drug does not include a prescription drug that is a
639 controlled substance
640 (5) Prepackaged drug means a prescription drug that
641 (a) is not listed under federal or state law as a Schedule I II ill IV or V drug and
642 (b) is packaged in a fixed quantity per package by
643 (i) the drug manufacturer
644 (ii) a pharmaceutical wholesaler or distributor or
645 (iii) a pharmacy licensed under this title
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1st Sub (Green) SB 55 02-07-14 416 PM
646 Section 9 Section 58-17b-803 is enacted to read
647 58-17b-803 Qualifications for licensure as a dispensing medical practitioner -shy
648 Scope of practice
649 (1) An applicant for a license as a dispensing medical practitioner shall
650 (a) be licensed in good standing under at least one of the chapters listed in Subsection
651 58-17b-l02(23)(a) and
652 (b) submit an application for a license as a dispensing medical practitioner in a form
653 prescribed by the division and pay a fee established by the S [depal tment] divisionS ~
654 (2) The division shall accept the licensing in good standing under Subsection (1) in lieu
655 of requiring an applicant for a license under this part to comply with Sections 58-17b-303 and
656
657 (3) A dispensing medical practitioner may dispense in accordance with this part
658 (a) a cosmetic drug and an injectable weight loss drug if
659 (i) the drug was prescribed by the dispensing medical practitioner to the dispensing
660 medical practitioners patient and
661 Oi) the dispensing medical practitioner complies with administrative rules adopted by
662 the division under Subsection 58-17-802(1)
663 (b) a cancer drug treatment regimen if the dispensing medical practitioner complies
664 with Section 58-17b-805 and
665 (c) a pre-packaged drug to an employee or a dependent of an employee at an employer
666 sponsored clinic if the dispensing medical practitioner
667 (i) treats an employee or the dependent of an employee of one of an exclusive group
668 of employers at an employer sponsored clinic
669 (ii) prescribes a prepackaged drug to the employee or the employees dependent
670 (iii) dispenses the prepackaged drug at the employer sponsored clinic and
671 (iv) complies with administrative rules adopted by the division in consultation with the
672 Board of Pharmacy that establish labeling record keeping patient counseling purchasing and
673 distribution operating treatment quality of care and storage requirements
674 (4) A dispensing medical practitioner
675 Ca) shall inform the patient
676 (i) that the drug dispensed by the practitioner may be obtained from a pharmacy
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02-07-14 416 PM 1st Sub (Green) SB 55
739 58-17b-806 Dispensing medical practitioner -- Dispensing medical practitioner
740 clinic pharmacy -- Unprofessional and Unlawful conduct
741 ill S Ull S The division S [ iii consultation witb tile boal d shall
742 (a) I epol t a violation of this chapter b a dispensing medical pi actitiollel to] shall consult
742a with S the
743 dispensing medical practitioners appropriate licensing board as designated in Subsection
744 5S-17b-l02(23)(a) S reeardine a violation oftMs chapterS and
745 (hl S the Pharmacy Board shall if requested by the licensine board of the dispensine
745a medical practitionerS assist the licensing board for the dispensing medical practitioner with
745b reviewing the
746 violations of the provisions of this chapter
747 (2) The division S [ in collabOi atioll with the Boal d ofPhall1l3C]S may take
747a appropriate
748 action against a dispensing medical practitioner in accordance with this chapter if the
749 licensing board designated in Subsection 58-17b- 02(23)(a) recommends to the division that
750 action be taken under this chapter
751 (3) The division in consultation with the board is the primary enforcer under this
752 chapter for a dispensing medical practitioner clinic pharmacy licensed under Section
753 58-17b-804
754 Section 13 Section 58-31b-502 is amended to read
755 58-31b-502 Unprofessional conduct
756 Unprofessional conduct includes
757 (l) failure to safeguard a patients right to privacy as to the patients person condition
758 diagnosis personal effects or any other matter about which the licensee is privileged to know
759 because of the licensees or person with a certifications position or practice as a nurse or
760 practice as a medication aide certified
761 (2) failure to provide nursing service or service as a medication aide certified in a
762 manner that demonstrates respect for the patients human dignity and unique personal character
763 and needs without regard to the patients race religion ethnic background socioeconomic
764 status age sex or the nature of the patients health problem
765 (3) engaging in sexual relations with a patient during any
766 (a) period when a generally recognized professional relationship exists between the
767 person licensed or certified under this chapter and patient or
768 (b) extended period when a patient has reasonable cause to believe a professional
769 relationship exists between the person licensed or certified under the provisions of this chapter
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LEGISLA TIVE GENERAL COUNSEL SB138 ct Approved for Filing Sc Allred ct
ct 02-04-14 1220 PM ct
1 CONTROLLED SUBSTANCES ACT AMENDMENTS
2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Evan J Vickers
5 House Sponsor Stewart Barlow
6
7 LONG TITLE
8 General Description
9 This bill modifies the Utah Controlled Substances Act regarding prescriptions for
10 controlled substances
11 Highlighted Provisions
12 This bill
13 ~ provides that more than one controlled substance may be included in a prescription
14 Money Appropriated in this Bill
15 None
16 Other Special Clauses
17 None
18 Utah Code Sections Affected
19 AMENDS
20 58-37-6 as last amended by Laws of Utah 2012 Chapter 272
21
22 Be it enacted by the Legislature of the state ofUtah
23 Section 1 Section 58-37-6 is amended to read
24 58-37-6 License to manufacture produce distribute dispense administer or
25 conduct research -- Issuance by division -- Denial suspension or revocation -- Records
26
27
required -- Prescriptions
(1) (a) The division may adopt rules relating to the licensing and control of the bull
1111111111111111111111111111111111111111
SB138 02-04-14 1220 PM
214 (ii) the prescribed controlled substance is to be used in research
215 (f) Except when administered directly to an ultimate user by a licensed practitioner
216 controlled substances are subject to the following restrictions
217 (i) (A) A prescription for a Schedule IT substance may not be refilled
218 (B) A Schedule II controlled substance may not be filled in a quantity to exceed a
219 one-months supply as directed on the daily dosage rate of the prescriptions
220 (ii) A Schedule ill or IV controlled substance may be filled only within six months of
221 issuance and may not be refilled more than six months after the date of its original issuance or
222 be refilled more than five times after the date of the prescription unless renewed by the
223 practitioner
224 (iii) All other controlled substances in Schedule V may be refilled as the prescribers
225 prescription directs but they may not be refilled one year after the date the prescription was
226 issued unless renewed by the practitioner
227 (iv) Any prescription for a Schedule IT substance may not be dispensed if it is not
228 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days
229 after the date the prescription was issued or 30 days after the dispensing date if that date is
230 specified separately from the date of issue
231 (v) A practitioner may issue more than one prescription at the same time for the same
232 Schedule IT controlled substance but only under the following conditions
233 (A) no more than three prescriptions for the same Schedule IT controlled substance may
234 be issued at the same time
235 (B) no one prescription may exceed a 30-day supply
236 (C) a second or third prescription shall include the date of issuance and the date for
237 dispensing and
238 (D) unless the practitioner determines there is a valid medical reason to the contrary
239 the date for dispensing a second or third prescription may not be fewer than 30 days from the
240 dispensing date of the previous prescription
241 [(1i) Each prescription rot a controlled snbstance may eontain only one controlled
242 substance per pIescription frlim and may not contain any other legend dmg 01 prescription
243 item]
244 (g) An order for a controlled substance in Schedules IT through V for use by an
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LEGISLATIVE GENERAL COUNSEL it Approved for Filing CJ Dupont it
HB114
it 02-06-14855 AM it
1 MAIL-ORDER WHOLESALE DRUG AMENDMENTS 2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Stewart Barlow
5 Senate Sponsor ______
6
7 LONG TITLE
8 General Description
9 This bill amends the Pharmacy Practice Act
10 Highlighted Provisions
11 This bill
12 ~ amends the definition of a class C pharmacy subject to regulation under the
13 Pharmacy Practice Act
14 Money Appropriated in this Bill
15 None
16 Other Special Clauses
17 This bi II takes effect on July 1 2014
18 Utah Code Sections Affected
19 AMENDS
20 58-17b-102 as last amended by Laws of Utah 2013 Chapters 52 166 and 423
21
22 Be it enacted by the Legislature ofthe state ofUtah
23 Section 1 Section 58-17b-102 is amended to read
24 58-17b-102 Definitions
25 In addition to the definitions in Section 58-1-102 as used in this chapter
26
27
(1) Administering means
(a) the direct application of a prescription drug or device whether by injection
==bull =bull
1111111111111111111111111111111111111111
02-06-14855 AM HB114
59 (9) Centralized prescription processing means the processing by a pharmacy of a
60 request from another pharmacy to fill or refill a prescription drug order or to perform
61 processing functions such as dispensing drug utilization review claims adjudication refill
62 authorizations and therapeutic interventions
63 (10) Class A pharmacy means a pharmacy located in Utah that is authorized as a
64 retail pharmacy to compound or dispense a drug or dispense a device to the public under a
65 prescription order
66 (11) Class B pharmacy
67 (a) means a pharmacy located in Utah
68 (i) that is authorized to provide pharmaceutical care for patients in an institutional
69 setting and
70 (ii) whose primary purpose is to provide a physical environment for patients to obtain
71 health care services and
72 (b) (i) includes closed-door hospital clinic nuclear and branch pharmacies and
73 (ii) pharmaceutical administration and sterile product preparation facilities
74 (12) Class C pharmacy means a pharmacy [located ill Utah that is anthOl ized to
75 engage] that engages in the manufacture production wholesale or distribution of drugs or
76 devices in Utah
77 (13) Class D pharmacy means a nonresident pharmacy
78 (14) Class E pharmacy means all other pharmacies
79 (15) Closed-door pharmacy means a pharmacy that provides pharmaceutical care to a
80 defined and exclusive group of patients who have access to the services of the pharmacy
81 because they are treated by or have an affiliation with a specific entity including a health
82 maintenance organization or an infusion company but not including a hospital pharmacy a
83 retailer of goods to the general public or the office of a practitioner
84 (16) Collaborative pharmacy practice means a practice of pharmacy whereby one or
85 more pharmacists have jointly agreed on a voluntary basis to work in conjunction with one or
86 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical
87 care functions authorized by the practitioner or practitioners under certain specified conditions
88 or limitations
89 (17) Collaborative pharmacy practice agreement means a written and signed
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02-06-14855 AM HB114
369 and
370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in
371 collaboration with the board
372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501
373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and
374 may be further defined by rule
375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that
376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration
377 for animals
378 Section 2 Effective date
379 This bill takes effect on July I 2014
Legislative Review Note as of 2-4-14 1243 PM
Office of Legislative Research and General Counsel
- 13 shy
LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t
t 02-05-14 122PM t
1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG
2 AMENDMENTS
3 2014 GENERAL SESSION
4 STATE OF UTAH
5 Chief Sponsor Stewart Barlow
6 Senate Sponsor
7
8 LONG TITLE
9 General Description
10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from
11 its licensing requirements under certain circumstances
12 Highlighted Provisions
13 This bill
14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy
15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an
16 employer sponsored clinic and complies with other requirements
17 repeals subject to sunset review the provisions of this bill relating to the exemption
18 described above and
19 ~ makes technical and conforming changes
20 Money Appropriated in this Bill
21 None
22 Other Special Clauses
23 None
24 Utah Code Sections Affected
25 AMENDS
26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~
27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull
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HBI06 02-05-14 122 PM
28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278
29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234
30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351
31 ENACTS
32 58-17b-3097 Utah Code Annotated 1953
33
34 Be it enacted by the Legislature ofthe state ofUtah
35 Section 1 Section 58-17b-301 is amended to read
36 58-17b-301 License required -- License classifications for individuals
37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the
38 practice of a pharmacy technician except as specifically provided in Section 58-1-307
39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097
40 (2) The division shall issue to an individual who qualifies under this chapter a license
41 in the classification of
42 (a) pharmacist
43 (b) pharmacy intern or
44 (c) pharmacy technician
45 Section 2 Section 58-17b-302 is amended to read
46 58-17b-302 License required -- License classifications for pharmacy facilities
47 (l) A license is required to act as a pharmacy except as specifically exempted from
48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or
49
50 (2) The division shall issue a pharmacy license to a facility that qualifies under this
51 chapter in the classification of a
52 (a) class A pharmacy
53 (b) class B pharmacy
54 (c) class C pharmacy
55 (d) class D pharmacy or
56 (e) class E pharmacy
57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist
58 at the same address a separate license shall be required for each pharmacy
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02-05-14 122 PM HBI06
59 (4) The division may further define or supplement the classifications of pharmacies
60 The division may impose restrictions upon classifications to protect the public health safety
61 and welfare
62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by
63 rule
64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy
65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities
66 of the pharmacy regardless of the form of the business organization
67 Section 3 Section 58-17b-309 is amended to read
68 58-17b-309 Exemptions from licensure
69 (l) [For ptnp05C5 of] As used in this section
70 (a) Cosmetic drug
71 (i) means a prescription drug that is
72 (A) for the purpose of promoting attractiveness or altering the appearance of an
73 individual and
74 (8) listed as a cosmetic drug subject to the exemption under this section by the division
75 by administrative rule or has been expressly approved for online dispensing whether or not it is
76 dispensed online or through a physicians office and
77 (ii) does not include a prescription drug that is
78 (A) a controlled substance
79 (8) compounded by the physician or
80 (C) prescribed or used for the patient for the purpose of diagnosing curing or
81 preventing a disease
82 (b) Injectable weight loss drug
83 (i) means an injectable prescription drug
84 (A) prescribed to promote weight loss and
85 (8) listed as an injectable prescription drug subject to exemption under this section by
86 the division by administrative rule and
87 (ii) does not include a prescription drug that is a controlled substance
88 (c) Prescribing practitioner means an individual licensed under
89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with
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HB106 02-05-14 122 PM
90 prescriptive practice
91 (ii) Chapter 67 Utah Medical Practice Act
92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or
93 (iv) Chapter 70a Physician Assistant Act
94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l
95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the
96 acts or practices described in this section without being licensed under this chapter
97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the
98 individual notifies the division in writing of the individuals intent to dispense a drug under this
99 [snbsectioll] Subsection (2)
100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1
101 (c) an individual engaging in the practice of pharmacy technician under the direct
102 personal supervision of a pharmacist while making satisfactory progress in an approved
103 program as defined in division rule
104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an
105 injectable weight loss drug to the prescribing practitioners patient in accordance with
106 Subsection (4) or
107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists
108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic
109 drug to the optometrists patient in accordance with Subsection (4)
110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under
111 Subsection (2)( c) must take all examinations as required by division rule following completion
112 of an approved curriculum of education within the required time frame This exemption
113 expires immediately upon notification of a failing score of an examination and the individual
114 may not continue working as a pharmacy technician even under direct supervision
115 (4) A prescribing practitioner or optometrist is exempt from licensing under the
116 provisions of this part if the prescribing practitioner or optometrist
117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the
118 authority to dispense under Subsection (4)(b) and
119 (ii) informs the patient
120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing
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HB106 02-05-14 122 PM
152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the
153 prescribing practitioners or optometrists office and determine if the provisions of this section
154 are being met by the prescribing practitioner or optometrist
155 (d) If a prescribing practitioner or optometrist violates a provision of this section the
156 prescribing practitioner or optometrist may be subject to discipline under
157 (i) this chapter and
158 (ii) (A) Chapter 16a Utah Optometry Practice Act
159 (B) Chapter 31 b Nurse Practice Act
160 (C) Chapter 67 Utah Medical Practice Act
161 (D) Chapter 68 Utah Osteopathic Medical Practice Act
162 (E) Chapter 70a Physician Assistant Act or
163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act
164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the
165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah
166 Optometry Practice Act
167 Section 4 Section 58-17b-3095 is amended to read
168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy
169 Division study of dispensing practitioners
170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen
171 (a) means a prescription drug used to treat cancer manage its symptoms or provide
172 continuity of care for a cancer patient
173 (b) includes
174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal
175 methods and
176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize
177 physical and psychological symptoms or pain or to improve patient tolerance of cancer
178 treatments or prepare a patient for a subsequent course of therapy and
179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug
180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections
181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt
182 from licensure under this chapter
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HB106 02-05-14 122 PM
214 (ii) is acting under the direction of a prescribing practitioner who is immediately
215 available on site for any necessary consultation and who has complied with Subsection
216 (2)(b)(i)
217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the
218 outpatient clinic setting and
219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)
220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to
221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section
222 (b) The evaluation under this Subsection (3) shall include
223 (i) practitioner compliance with the requirements of this section and Section
224 58-l7b-309
225 (ii) current research on dispensing and patient safety
226 (iii) survey of other state dispensing laws and
227 (iv) recommendations for future action concerning practitioner dispensing
228 (c) The division shall report to the Legislatures Health and Human Services Interim
229 Committee by November 302012 and by November 302013 with the results and
230 recommendations from the evaluation required by this Subsection (3)
231 (4) This section sunsets in accordance with Section 631-1-258
232 Section 5 Section 58-17b-3097 is enacted to read
233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an
234 employer sponsored clinic
235 (1) As used in this section
236 (a) Employer sponsored clinic means an entity that offers health care only to the
237 employees of an exclusive group of employers and the employees dependents
238 (b) Health care is as defined in Section 31 A-J-301
239 (c) Prepackaged drug means a prescription drug that
240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and
241 (ii) is packaged in a fixed quantity per package by
242 (A) the drug manufacturer
243 (B) a pharmaceutical wholesaler or distributor or
244 (C) a pharmacy licensed under this title
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~ -- -------------------
02-05-14 122 PM HB106
245 Cd) Prescribing practitioner is as defined in Section 58-17b-309
246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309
247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing
248 requirements of this chapter if the prescribing practitioner
249 Ca) treats an employee of one of an exclusive group of employers at an employer
250 sponsored clinic
251 Cb) prescribes a prepackaged drug to the employee
252 Cc) dispenses the prepackaged drug at the employer sponsored clinic
253 (d) notifies the division
254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the
255 employer sponsored clinic and
256 (ii) of the drug the prescribing practitioner intends to dispense
257 Ce) determines that providing the prepackaged drug to the employee at the employer
258 sponsored clinic is in the employees best interest
259 (f) informs the employee
260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner
261 from a pharmacy that is unaffiliated with the prescribing practitioner
262 (ii) of the directions for appropriate use of the prepackaged drug
263 (iii) of potential side effects to the use of the prepackaged drug and
264 (iv) how to contact the prescribing practitioner if the employee has questions or
265 concerns regarding the drug
266 (g) offers the employee the opportunity to consult with a pharmacist if the employee
267 asks for patient counseling and
268 (h) follows the administrative rules for a prescribing practitioner at an employer
269 sponsored clinic established by the division under Subsection (4)
270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a
271 prepackaged drug under this section requires physician supervision in its scope ofpractice
272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the
273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter
274 68 Utah Osteopathic Medical Practice Act
275 (4) The division shall in consultation with the board of pharmacy and the Physicians
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HBI06 02-05-14 122 PM
276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title
277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping
278 patient counseling purchasing and distribution operating treatment quality of care and
279 storage requirements for a prescribing practitioner at an employer sponsored clinic
280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a
281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing
282 practitioner is in compliance with this section
283 (6) If a prescribing practitioner violates a provision of this section the prescribing
284 practitioner may be subject to discipline under
285 (a) this chapter and
286 (b) any other chapter that governs the terms of the prescribing practitioners license
287 (7) The division shall evaluate the exemption created by this section and report to the
288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1
289 2018 on the results of the evaluation and the divisions recommendations regarding the
290 exemption
291 Section 6 Section 631-1-258 is amended to read
292 631-1-258 Repeal dates Title 58
293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is
294 repealed July 12016
295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015
296 (3) Section 58-17b-3095 is repealed July 1 2015
297 (4) Section 58-17b-3097 is repealed on July 12018
298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1
299 2018
300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1
301 2023
302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing
303 Act is repealed July 1 2019
304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1
305 2015
306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is
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02-05-14 1 22 PM HB106
307 repealed July 12023
308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1
309 2014
310 [ttej] ill) Section 58-69-3025 is repealed on July 12015
311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017
Legislative Review Note as of 2-3-14 418 PM
Office of Legislative Research and General Counsel
- 11 shy
02-05-14 156 PM SB178
183 designated under Subsection (2)(f) (2)(g) or (4)(c) should be granted access to the database
184 and
185 (ii) establish the information to be provided by an emergency room employee under
186 Subsection (4)
187 (c) The division shall grant an employee designated under Subsection (2)(f) (2)(g) or
188 (4)( c) access to the database unless the division determines based on a background check that
189 the employee poses a security risk to the information contained in the database
190 (4) (a) An individual who is employed in the emergency room ofa hospital may
191 exercise access to the database under this Subsection (4) on behalf of a licensed practitioner if
192 the individual is designated under Subsection (4)( c) and the licensed practitioner
193 (i) is employed in the emergency room
194 Oi) is treating an emergency room patient for an emergency medical condition and
195 (iii) requests that an individual employed in the emergency room and designated under
196 Subsection (4)( c) obtain information regarding the patient from the database as needed in the
197 course of treatment
198 (b) The emergency room employee obtaining information from the database shall
199 when gaining access to the database provide to the database the name and any additional
200 identifiers regarding the requesting practitioner as required by division administrative rule
201 established under Subsection (3)(b)
202 (c) An individual employed in the emergency room under this Subsection (4) may
203 obtain information from the database as provided in Subsection (4)(a) if
204 (i) the employee is designated by the practitioner as an individual authorized to access
205 the information on behalf of the practitioner
206 (ii) the practitioner and the hospital operating the emergency room provide written
207 notice to the division of the identity of the designated employee and
208 (iii) the division
209 (A) grants the employee access to the database and
210 (B) provides the employee with a password that is unique to that employee to access
211 the database in order to permit the division to comply with the requirements of Subsection
212 58-37f-203(3)(b) with respect to the employee
213 (d) The division may impose a fee in accordance with Section 63J-I-504 on a
- 7
LEGISLATIVE GENERAL C01JNSEL SB55 iL Approved for Filing Cl Dupont iL lst Sub (Green)
iL 02-07-14 416 PM iL
Senator Evan J Vickers proposes the following substitute bill
PHARMACEUTICAL DISPENSING AMENDMENTS
2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Evan J Vickers
5 House Sponsor Stewart Barlow
6
7 LONG TITLE
8 General Description
9 This bill amends the Pharmacy Practice Act to create a dispensing medical practitioner
10 license and a license classification for a dispensing medical practitioner clinic
11 pharmacy
12 Highlighted Provisions
13 This bill
14 defines terms
15 establishes the license classification dispensing medical practitioner under the
16 Pharmacy Practice Act for medical practitioners who prescribe and dispense a drug
17 establishes the pharmacy facility license classification dispensing medical
18 practitioner clinic pharmacy under the Pharmacy Practice Act
19 creates Part 8 Dispensing Medical Practitioner and Dispensing Medical Practitioner
20 Clinic Pharmacy
21 removes the exemption from the Pharmacy Practice Act for medical practitioners
22 who prescribe and dispense a cosmetic drug injectable weight loss drug or a cancer
23 drug treatment regimen
24 requires a license as a dispensing medical practitioner for a health care practitioner 00
25 to dispense bull bull=
1111111111111111111111111111111111111111111111111111111
02-07-14 416 PM 1st Sub (Green) SB 55
615 Practitioner Clinic Pharmacy II
616 Section 8 Section 58-17b-802 is enacted to read
617 58-17b-802 Definitions
618 As used in this part
619 (1) (a) Cosmetic drug means a prescription drug that
620 (i) is for the purpose of promoting attractiveness or altering the appearance of an
621 individual and
622 (ii) (A) is listed as a cosmetic drug subject to the exemption under this section by the
623 division by administrative rule or
624 CB) has been expressly approved for online dispensing whether or not it is dispensed
625 online or through a physicians office
626 (b) Cosmetic drug does not include a prescription drug that is
627 (i) a controlled substance
628 (ii) compounded by the physician or
629 (iii) prescribed or used for the patient for the purpose of diagnosing curing or
630 preventing a disease
631 (2) Employer sponsored clinic means an entity that S-t has a medical director who is
631 a licensed as a physician as defined in Section 58-67-102 and S offers health care only to the
632 employees of an exclusive group of employers and the employees dependents
633 (3) Health care is as defined in Section 31A-1-301
634 (4) Ca) Injectable weight loss drug means an injectable prescription drug
635 (n prescribed to promote weight loss and
636 (ii) listed as an injectable prescription drug subject to exemption under this section by
637 the division by administrative rule
638 (b) Injectable weight loss drug does not include a prescription drug that is a
639 controlled substance
640 (5) Prepackaged drug means a prescription drug that
641 (a) is not listed under federal or state law as a Schedule I II ill IV or V drug and
642 (b) is packaged in a fixed quantity per package by
643 (i) the drug manufacturer
644 (ii) a pharmaceutical wholesaler or distributor or
645 (iii) a pharmacy licensed under this title
- 21 Senate Committee Amendments 2-13-2014 Jplcjd
1st Sub (Green) SB 55 02-07-14 416 PM
646 Section 9 Section 58-17b-803 is enacted to read
647 58-17b-803 Qualifications for licensure as a dispensing medical practitioner -shy
648 Scope of practice
649 (1) An applicant for a license as a dispensing medical practitioner shall
650 (a) be licensed in good standing under at least one of the chapters listed in Subsection
651 58-17b-l02(23)(a) and
652 (b) submit an application for a license as a dispensing medical practitioner in a form
653 prescribed by the division and pay a fee established by the S [depal tment] divisionS ~
654 (2) The division shall accept the licensing in good standing under Subsection (1) in lieu
655 of requiring an applicant for a license under this part to comply with Sections 58-17b-303 and
656
657 (3) A dispensing medical practitioner may dispense in accordance with this part
658 (a) a cosmetic drug and an injectable weight loss drug if
659 (i) the drug was prescribed by the dispensing medical practitioner to the dispensing
660 medical practitioners patient and
661 Oi) the dispensing medical practitioner complies with administrative rules adopted by
662 the division under Subsection 58-17-802(1)
663 (b) a cancer drug treatment regimen if the dispensing medical practitioner complies
664 with Section 58-17b-805 and
665 (c) a pre-packaged drug to an employee or a dependent of an employee at an employer
666 sponsored clinic if the dispensing medical practitioner
667 (i) treats an employee or the dependent of an employee of one of an exclusive group
668 of employers at an employer sponsored clinic
669 (ii) prescribes a prepackaged drug to the employee or the employees dependent
670 (iii) dispenses the prepackaged drug at the employer sponsored clinic and
671 (iv) complies with administrative rules adopted by the division in consultation with the
672 Board of Pharmacy that establish labeling record keeping patient counseling purchasing and
673 distribution operating treatment quality of care and storage requirements
674 (4) A dispensing medical practitioner
675 Ca) shall inform the patient
676 (i) that the drug dispensed by the practitioner may be obtained from a pharmacy
- 22 - Senate Committee Amendments 2-13-2014 picjd
02-07-14 416 PM 1st Sub (Green) SB 55
739 58-17b-806 Dispensing medical practitioner -- Dispensing medical practitioner
740 clinic pharmacy -- Unprofessional and Unlawful conduct
741 ill S Ull S The division S [ iii consultation witb tile boal d shall
742 (a) I epol t a violation of this chapter b a dispensing medical pi actitiollel to] shall consult
742a with S the
743 dispensing medical practitioners appropriate licensing board as designated in Subsection
744 5S-17b-l02(23)(a) S reeardine a violation oftMs chapterS and
745 (hl S the Pharmacy Board shall if requested by the licensine board of the dispensine
745a medical practitionerS assist the licensing board for the dispensing medical practitioner with
745b reviewing the
746 violations of the provisions of this chapter
747 (2) The division S [ in collabOi atioll with the Boal d ofPhall1l3C]S may take
747a appropriate
748 action against a dispensing medical practitioner in accordance with this chapter if the
749 licensing board designated in Subsection 58-17b- 02(23)(a) recommends to the division that
750 action be taken under this chapter
751 (3) The division in consultation with the board is the primary enforcer under this
752 chapter for a dispensing medical practitioner clinic pharmacy licensed under Section
753 58-17b-804
754 Section 13 Section 58-31b-502 is amended to read
755 58-31b-502 Unprofessional conduct
756 Unprofessional conduct includes
757 (l) failure to safeguard a patients right to privacy as to the patients person condition
758 diagnosis personal effects or any other matter about which the licensee is privileged to know
759 because of the licensees or person with a certifications position or practice as a nurse or
760 practice as a medication aide certified
761 (2) failure to provide nursing service or service as a medication aide certified in a
762 manner that demonstrates respect for the patients human dignity and unique personal character
763 and needs without regard to the patients race religion ethnic background socioeconomic
764 status age sex or the nature of the patients health problem
765 (3) engaging in sexual relations with a patient during any
766 (a) period when a generally recognized professional relationship exists between the
767 person licensed or certified under this chapter and patient or
768 (b) extended period when a patient has reasonable cause to believe a professional
769 relationship exists between the person licensed or certified under the provisions of this chapter
- 25 - Senate Committee Amendments 2-13-2014Iplcjd
LEGISLA TIVE GENERAL COUNSEL SB138 ct Approved for Filing Sc Allred ct
ct 02-04-14 1220 PM ct
1 CONTROLLED SUBSTANCES ACT AMENDMENTS
2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Evan J Vickers
5 House Sponsor Stewart Barlow
6
7 LONG TITLE
8 General Description
9 This bill modifies the Utah Controlled Substances Act regarding prescriptions for
10 controlled substances
11 Highlighted Provisions
12 This bill
13 ~ provides that more than one controlled substance may be included in a prescription
14 Money Appropriated in this Bill
15 None
16 Other Special Clauses
17 None
18 Utah Code Sections Affected
19 AMENDS
20 58-37-6 as last amended by Laws of Utah 2012 Chapter 272
21
22 Be it enacted by the Legislature of the state ofUtah
23 Section 1 Section 58-37-6 is amended to read
24 58-37-6 License to manufacture produce distribute dispense administer or
25 conduct research -- Issuance by division -- Denial suspension or revocation -- Records
26
27
required -- Prescriptions
(1) (a) The division may adopt rules relating to the licensing and control of the bull
1111111111111111111111111111111111111111
SB138 02-04-14 1220 PM
214 (ii) the prescribed controlled substance is to be used in research
215 (f) Except when administered directly to an ultimate user by a licensed practitioner
216 controlled substances are subject to the following restrictions
217 (i) (A) A prescription for a Schedule IT substance may not be refilled
218 (B) A Schedule II controlled substance may not be filled in a quantity to exceed a
219 one-months supply as directed on the daily dosage rate of the prescriptions
220 (ii) A Schedule ill or IV controlled substance may be filled only within six months of
221 issuance and may not be refilled more than six months after the date of its original issuance or
222 be refilled more than five times after the date of the prescription unless renewed by the
223 practitioner
224 (iii) All other controlled substances in Schedule V may be refilled as the prescribers
225 prescription directs but they may not be refilled one year after the date the prescription was
226 issued unless renewed by the practitioner
227 (iv) Any prescription for a Schedule IT substance may not be dispensed if it is not
228 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days
229 after the date the prescription was issued or 30 days after the dispensing date if that date is
230 specified separately from the date of issue
231 (v) A practitioner may issue more than one prescription at the same time for the same
232 Schedule IT controlled substance but only under the following conditions
233 (A) no more than three prescriptions for the same Schedule IT controlled substance may
234 be issued at the same time
235 (B) no one prescription may exceed a 30-day supply
236 (C) a second or third prescription shall include the date of issuance and the date for
237 dispensing and
238 (D) unless the practitioner determines there is a valid medical reason to the contrary
239 the date for dispensing a second or third prescription may not be fewer than 30 days from the
240 dispensing date of the previous prescription
241 [(1i) Each prescription rot a controlled snbstance may eontain only one controlled
242 substance per pIescription frlim and may not contain any other legend dmg 01 prescription
243 item]
244 (g) An order for a controlled substance in Schedules IT through V for use by an
- 8 shy
LEGISLATIVE GENERAL COUNSEL it Approved for Filing CJ Dupont it
HB114
it 02-06-14855 AM it
1 MAIL-ORDER WHOLESALE DRUG AMENDMENTS 2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Stewart Barlow
5 Senate Sponsor ______
6
7 LONG TITLE
8 General Description
9 This bill amends the Pharmacy Practice Act
10 Highlighted Provisions
11 This bill
12 ~ amends the definition of a class C pharmacy subject to regulation under the
13 Pharmacy Practice Act
14 Money Appropriated in this Bill
15 None
16 Other Special Clauses
17 This bi II takes effect on July 1 2014
18 Utah Code Sections Affected
19 AMENDS
20 58-17b-102 as last amended by Laws of Utah 2013 Chapters 52 166 and 423
21
22 Be it enacted by the Legislature ofthe state ofUtah
23 Section 1 Section 58-17b-102 is amended to read
24 58-17b-102 Definitions
25 In addition to the definitions in Section 58-1-102 as used in this chapter
26
27
(1) Administering means
(a) the direct application of a prescription drug or device whether by injection
==bull =bull
1111111111111111111111111111111111111111
02-06-14855 AM HB114
59 (9) Centralized prescription processing means the processing by a pharmacy of a
60 request from another pharmacy to fill or refill a prescription drug order or to perform
61 processing functions such as dispensing drug utilization review claims adjudication refill
62 authorizations and therapeutic interventions
63 (10) Class A pharmacy means a pharmacy located in Utah that is authorized as a
64 retail pharmacy to compound or dispense a drug or dispense a device to the public under a
65 prescription order
66 (11) Class B pharmacy
67 (a) means a pharmacy located in Utah
68 (i) that is authorized to provide pharmaceutical care for patients in an institutional
69 setting and
70 (ii) whose primary purpose is to provide a physical environment for patients to obtain
71 health care services and
72 (b) (i) includes closed-door hospital clinic nuclear and branch pharmacies and
73 (ii) pharmaceutical administration and sterile product preparation facilities
74 (12) Class C pharmacy means a pharmacy [located ill Utah that is anthOl ized to
75 engage] that engages in the manufacture production wholesale or distribution of drugs or
76 devices in Utah
77 (13) Class D pharmacy means a nonresident pharmacy
78 (14) Class E pharmacy means all other pharmacies
79 (15) Closed-door pharmacy means a pharmacy that provides pharmaceutical care to a
80 defined and exclusive group of patients who have access to the services of the pharmacy
81 because they are treated by or have an affiliation with a specific entity including a health
82 maintenance organization or an infusion company but not including a hospital pharmacy a
83 retailer of goods to the general public or the office of a practitioner
84 (16) Collaborative pharmacy practice means a practice of pharmacy whereby one or
85 more pharmacists have jointly agreed on a voluntary basis to work in conjunction with one or
86 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical
87 care functions authorized by the practitioner or practitioners under certain specified conditions
88 or limitations
89 (17) Collaborative pharmacy practice agreement means a written and signed
- 3 shy
02-06-14855 AM HB114
369 and
370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in
371 collaboration with the board
372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501
373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and
374 may be further defined by rule
375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that
376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration
377 for animals
378 Section 2 Effective date
379 This bill takes effect on July I 2014
Legislative Review Note as of 2-4-14 1243 PM
Office of Legislative Research and General Counsel
- 13 shy
LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t
t 02-05-14 122PM t
1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG
2 AMENDMENTS
3 2014 GENERAL SESSION
4 STATE OF UTAH
5 Chief Sponsor Stewart Barlow
6 Senate Sponsor
7
8 LONG TITLE
9 General Description
10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from
11 its licensing requirements under certain circumstances
12 Highlighted Provisions
13 This bill
14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy
15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an
16 employer sponsored clinic and complies with other requirements
17 repeals subject to sunset review the provisions of this bill relating to the exemption
18 described above and
19 ~ makes technical and conforming changes
20 Money Appropriated in this Bill
21 None
22 Other Special Clauses
23 None
24 Utah Code Sections Affected
25 AMENDS
26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~
27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull
1111111111111111111111111111111111111111
HBI06 02-05-14 122 PM
28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278
29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234
30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351
31 ENACTS
32 58-17b-3097 Utah Code Annotated 1953
33
34 Be it enacted by the Legislature ofthe state ofUtah
35 Section 1 Section 58-17b-301 is amended to read
36 58-17b-301 License required -- License classifications for individuals
37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the
38 practice of a pharmacy technician except as specifically provided in Section 58-1-307
39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097
40 (2) The division shall issue to an individual who qualifies under this chapter a license
41 in the classification of
42 (a) pharmacist
43 (b) pharmacy intern or
44 (c) pharmacy technician
45 Section 2 Section 58-17b-302 is amended to read
46 58-17b-302 License required -- License classifications for pharmacy facilities
47 (l) A license is required to act as a pharmacy except as specifically exempted from
48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or
49
50 (2) The division shall issue a pharmacy license to a facility that qualifies under this
51 chapter in the classification of a
52 (a) class A pharmacy
53 (b) class B pharmacy
54 (c) class C pharmacy
55 (d) class D pharmacy or
56 (e) class E pharmacy
57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist
58 at the same address a separate license shall be required for each pharmacy
-2shy
02-05-14 122 PM HBI06
59 (4) The division may further define or supplement the classifications of pharmacies
60 The division may impose restrictions upon classifications to protect the public health safety
61 and welfare
62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by
63 rule
64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy
65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities
66 of the pharmacy regardless of the form of the business organization
67 Section 3 Section 58-17b-309 is amended to read
68 58-17b-309 Exemptions from licensure
69 (l) [For ptnp05C5 of] As used in this section
70 (a) Cosmetic drug
71 (i) means a prescription drug that is
72 (A) for the purpose of promoting attractiveness or altering the appearance of an
73 individual and
74 (8) listed as a cosmetic drug subject to the exemption under this section by the division
75 by administrative rule or has been expressly approved for online dispensing whether or not it is
76 dispensed online or through a physicians office and
77 (ii) does not include a prescription drug that is
78 (A) a controlled substance
79 (8) compounded by the physician or
80 (C) prescribed or used for the patient for the purpose of diagnosing curing or
81 preventing a disease
82 (b) Injectable weight loss drug
83 (i) means an injectable prescription drug
84 (A) prescribed to promote weight loss and
85 (8) listed as an injectable prescription drug subject to exemption under this section by
86 the division by administrative rule and
87 (ii) does not include a prescription drug that is a controlled substance
88 (c) Prescribing practitioner means an individual licensed under
89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with
- 3 shy
HB106 02-05-14 122 PM
90 prescriptive practice
91 (ii) Chapter 67 Utah Medical Practice Act
92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or
93 (iv) Chapter 70a Physician Assistant Act
94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l
95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the
96 acts or practices described in this section without being licensed under this chapter
97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the
98 individual notifies the division in writing of the individuals intent to dispense a drug under this
99 [snbsectioll] Subsection (2)
100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1
101 (c) an individual engaging in the practice of pharmacy technician under the direct
102 personal supervision of a pharmacist while making satisfactory progress in an approved
103 program as defined in division rule
104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an
105 injectable weight loss drug to the prescribing practitioners patient in accordance with
106 Subsection (4) or
107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists
108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic
109 drug to the optometrists patient in accordance with Subsection (4)
110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under
111 Subsection (2)( c) must take all examinations as required by division rule following completion
112 of an approved curriculum of education within the required time frame This exemption
113 expires immediately upon notification of a failing score of an examination and the individual
114 may not continue working as a pharmacy technician even under direct supervision
115 (4) A prescribing practitioner or optometrist is exempt from licensing under the
116 provisions of this part if the prescribing practitioner or optometrist
117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the
118 authority to dispense under Subsection (4)(b) and
119 (ii) informs the patient
120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing
-4shy
HB106 02-05-14 122 PM
152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the
153 prescribing practitioners or optometrists office and determine if the provisions of this section
154 are being met by the prescribing practitioner or optometrist
155 (d) If a prescribing practitioner or optometrist violates a provision of this section the
156 prescribing practitioner or optometrist may be subject to discipline under
157 (i) this chapter and
158 (ii) (A) Chapter 16a Utah Optometry Practice Act
159 (B) Chapter 31 b Nurse Practice Act
160 (C) Chapter 67 Utah Medical Practice Act
161 (D) Chapter 68 Utah Osteopathic Medical Practice Act
162 (E) Chapter 70a Physician Assistant Act or
163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act
164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the
165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah
166 Optometry Practice Act
167 Section 4 Section 58-17b-3095 is amended to read
168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy
169 Division study of dispensing practitioners
170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen
171 (a) means a prescription drug used to treat cancer manage its symptoms or provide
172 continuity of care for a cancer patient
173 (b) includes
174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal
175 methods and
176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize
177 physical and psychological symptoms or pain or to improve patient tolerance of cancer
178 treatments or prepare a patient for a subsequent course of therapy and
179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug
180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections
181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt
182 from licensure under this chapter
- 6shy
HB106 02-05-14 122 PM
214 (ii) is acting under the direction of a prescribing practitioner who is immediately
215 available on site for any necessary consultation and who has complied with Subsection
216 (2)(b)(i)
217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the
218 outpatient clinic setting and
219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)
220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to
221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section
222 (b) The evaluation under this Subsection (3) shall include
223 (i) practitioner compliance with the requirements of this section and Section
224 58-l7b-309
225 (ii) current research on dispensing and patient safety
226 (iii) survey of other state dispensing laws and
227 (iv) recommendations for future action concerning practitioner dispensing
228 (c) The division shall report to the Legislatures Health and Human Services Interim
229 Committee by November 302012 and by November 302013 with the results and
230 recommendations from the evaluation required by this Subsection (3)
231 (4) This section sunsets in accordance with Section 631-1-258
232 Section 5 Section 58-17b-3097 is enacted to read
233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an
234 employer sponsored clinic
235 (1) As used in this section
236 (a) Employer sponsored clinic means an entity that offers health care only to the
237 employees of an exclusive group of employers and the employees dependents
238 (b) Health care is as defined in Section 31 A-J-301
239 (c) Prepackaged drug means a prescription drug that
240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and
241 (ii) is packaged in a fixed quantity per package by
242 (A) the drug manufacturer
243 (B) a pharmaceutical wholesaler or distributor or
244 (C) a pharmacy licensed under this title
- 8 shy
~ -- -------------------
02-05-14 122 PM HB106
245 Cd) Prescribing practitioner is as defined in Section 58-17b-309
246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309
247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing
248 requirements of this chapter if the prescribing practitioner
249 Ca) treats an employee of one of an exclusive group of employers at an employer
250 sponsored clinic
251 Cb) prescribes a prepackaged drug to the employee
252 Cc) dispenses the prepackaged drug at the employer sponsored clinic
253 (d) notifies the division
254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the
255 employer sponsored clinic and
256 (ii) of the drug the prescribing practitioner intends to dispense
257 Ce) determines that providing the prepackaged drug to the employee at the employer
258 sponsored clinic is in the employees best interest
259 (f) informs the employee
260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner
261 from a pharmacy that is unaffiliated with the prescribing practitioner
262 (ii) of the directions for appropriate use of the prepackaged drug
263 (iii) of potential side effects to the use of the prepackaged drug and
264 (iv) how to contact the prescribing practitioner if the employee has questions or
265 concerns regarding the drug
266 (g) offers the employee the opportunity to consult with a pharmacist if the employee
267 asks for patient counseling and
268 (h) follows the administrative rules for a prescribing practitioner at an employer
269 sponsored clinic established by the division under Subsection (4)
270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a
271 prepackaged drug under this section requires physician supervision in its scope ofpractice
272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the
273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter
274 68 Utah Osteopathic Medical Practice Act
275 (4) The division shall in consultation with the board of pharmacy and the Physicians
- 9 shy
HBI06 02-05-14 122 PM
276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title
277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping
278 patient counseling purchasing and distribution operating treatment quality of care and
279 storage requirements for a prescribing practitioner at an employer sponsored clinic
280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a
281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing
282 practitioner is in compliance with this section
283 (6) If a prescribing practitioner violates a provision of this section the prescribing
284 practitioner may be subject to discipline under
285 (a) this chapter and
286 (b) any other chapter that governs the terms of the prescribing practitioners license
287 (7) The division shall evaluate the exemption created by this section and report to the
288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1
289 2018 on the results of the evaluation and the divisions recommendations regarding the
290 exemption
291 Section 6 Section 631-1-258 is amended to read
292 631-1-258 Repeal dates Title 58
293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is
294 repealed July 12016
295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015
296 (3) Section 58-17b-3095 is repealed July 1 2015
297 (4) Section 58-17b-3097 is repealed on July 12018
298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1
299 2018
300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1
301 2023
302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing
303 Act is repealed July 1 2019
304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1
305 2015
306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is
- 10shy
02-05-14 1 22 PM HB106
307 repealed July 12023
308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1
309 2014
310 [ttej] ill) Section 58-69-3025 is repealed on July 12015
311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017
Legislative Review Note as of 2-3-14 418 PM
Office of Legislative Research and General Counsel
- 11 shy
LEGISLATIVE GENERAL C01JNSEL SB55 iL Approved for Filing Cl Dupont iL lst Sub (Green)
iL 02-07-14 416 PM iL
Senator Evan J Vickers proposes the following substitute bill
PHARMACEUTICAL DISPENSING AMENDMENTS
2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Evan J Vickers
5 House Sponsor Stewart Barlow
6
7 LONG TITLE
8 General Description
9 This bill amends the Pharmacy Practice Act to create a dispensing medical practitioner
10 license and a license classification for a dispensing medical practitioner clinic
11 pharmacy
12 Highlighted Provisions
13 This bill
14 defines terms
15 establishes the license classification dispensing medical practitioner under the
16 Pharmacy Practice Act for medical practitioners who prescribe and dispense a drug
17 establishes the pharmacy facility license classification dispensing medical
18 practitioner clinic pharmacy under the Pharmacy Practice Act
19 creates Part 8 Dispensing Medical Practitioner and Dispensing Medical Practitioner
20 Clinic Pharmacy
21 removes the exemption from the Pharmacy Practice Act for medical practitioners
22 who prescribe and dispense a cosmetic drug injectable weight loss drug or a cancer
23 drug treatment regimen
24 requires a license as a dispensing medical practitioner for a health care practitioner 00
25 to dispense bull bull=
1111111111111111111111111111111111111111111111111111111
02-07-14 416 PM 1st Sub (Green) SB 55
615 Practitioner Clinic Pharmacy II
616 Section 8 Section 58-17b-802 is enacted to read
617 58-17b-802 Definitions
618 As used in this part
619 (1) (a) Cosmetic drug means a prescription drug that
620 (i) is for the purpose of promoting attractiveness or altering the appearance of an
621 individual and
622 (ii) (A) is listed as a cosmetic drug subject to the exemption under this section by the
623 division by administrative rule or
624 CB) has been expressly approved for online dispensing whether or not it is dispensed
625 online or through a physicians office
626 (b) Cosmetic drug does not include a prescription drug that is
627 (i) a controlled substance
628 (ii) compounded by the physician or
629 (iii) prescribed or used for the patient for the purpose of diagnosing curing or
630 preventing a disease
631 (2) Employer sponsored clinic means an entity that S-t has a medical director who is
631 a licensed as a physician as defined in Section 58-67-102 and S offers health care only to the
632 employees of an exclusive group of employers and the employees dependents
633 (3) Health care is as defined in Section 31A-1-301
634 (4) Ca) Injectable weight loss drug means an injectable prescription drug
635 (n prescribed to promote weight loss and
636 (ii) listed as an injectable prescription drug subject to exemption under this section by
637 the division by administrative rule
638 (b) Injectable weight loss drug does not include a prescription drug that is a
639 controlled substance
640 (5) Prepackaged drug means a prescription drug that
641 (a) is not listed under federal or state law as a Schedule I II ill IV or V drug and
642 (b) is packaged in a fixed quantity per package by
643 (i) the drug manufacturer
644 (ii) a pharmaceutical wholesaler or distributor or
645 (iii) a pharmacy licensed under this title
- 21 Senate Committee Amendments 2-13-2014 Jplcjd
1st Sub (Green) SB 55 02-07-14 416 PM
646 Section 9 Section 58-17b-803 is enacted to read
647 58-17b-803 Qualifications for licensure as a dispensing medical practitioner -shy
648 Scope of practice
649 (1) An applicant for a license as a dispensing medical practitioner shall
650 (a) be licensed in good standing under at least one of the chapters listed in Subsection
651 58-17b-l02(23)(a) and
652 (b) submit an application for a license as a dispensing medical practitioner in a form
653 prescribed by the division and pay a fee established by the S [depal tment] divisionS ~
654 (2) The division shall accept the licensing in good standing under Subsection (1) in lieu
655 of requiring an applicant for a license under this part to comply with Sections 58-17b-303 and
656
657 (3) A dispensing medical practitioner may dispense in accordance with this part
658 (a) a cosmetic drug and an injectable weight loss drug if
659 (i) the drug was prescribed by the dispensing medical practitioner to the dispensing
660 medical practitioners patient and
661 Oi) the dispensing medical practitioner complies with administrative rules adopted by
662 the division under Subsection 58-17-802(1)
663 (b) a cancer drug treatment regimen if the dispensing medical practitioner complies
664 with Section 58-17b-805 and
665 (c) a pre-packaged drug to an employee or a dependent of an employee at an employer
666 sponsored clinic if the dispensing medical practitioner
667 (i) treats an employee or the dependent of an employee of one of an exclusive group
668 of employers at an employer sponsored clinic
669 (ii) prescribes a prepackaged drug to the employee or the employees dependent
670 (iii) dispenses the prepackaged drug at the employer sponsored clinic and
671 (iv) complies with administrative rules adopted by the division in consultation with the
672 Board of Pharmacy that establish labeling record keeping patient counseling purchasing and
673 distribution operating treatment quality of care and storage requirements
674 (4) A dispensing medical practitioner
675 Ca) shall inform the patient
676 (i) that the drug dispensed by the practitioner may be obtained from a pharmacy
- 22 - Senate Committee Amendments 2-13-2014 picjd
02-07-14 416 PM 1st Sub (Green) SB 55
739 58-17b-806 Dispensing medical practitioner -- Dispensing medical practitioner
740 clinic pharmacy -- Unprofessional and Unlawful conduct
741 ill S Ull S The division S [ iii consultation witb tile boal d shall
742 (a) I epol t a violation of this chapter b a dispensing medical pi actitiollel to] shall consult
742a with S the
743 dispensing medical practitioners appropriate licensing board as designated in Subsection
744 5S-17b-l02(23)(a) S reeardine a violation oftMs chapterS and
745 (hl S the Pharmacy Board shall if requested by the licensine board of the dispensine
745a medical practitionerS assist the licensing board for the dispensing medical practitioner with
745b reviewing the
746 violations of the provisions of this chapter
747 (2) The division S [ in collabOi atioll with the Boal d ofPhall1l3C]S may take
747a appropriate
748 action against a dispensing medical practitioner in accordance with this chapter if the
749 licensing board designated in Subsection 58-17b- 02(23)(a) recommends to the division that
750 action be taken under this chapter
751 (3) The division in consultation with the board is the primary enforcer under this
752 chapter for a dispensing medical practitioner clinic pharmacy licensed under Section
753 58-17b-804
754 Section 13 Section 58-31b-502 is amended to read
755 58-31b-502 Unprofessional conduct
756 Unprofessional conduct includes
757 (l) failure to safeguard a patients right to privacy as to the patients person condition
758 diagnosis personal effects or any other matter about which the licensee is privileged to know
759 because of the licensees or person with a certifications position or practice as a nurse or
760 practice as a medication aide certified
761 (2) failure to provide nursing service or service as a medication aide certified in a
762 manner that demonstrates respect for the patients human dignity and unique personal character
763 and needs without regard to the patients race religion ethnic background socioeconomic
764 status age sex or the nature of the patients health problem
765 (3) engaging in sexual relations with a patient during any
766 (a) period when a generally recognized professional relationship exists between the
767 person licensed or certified under this chapter and patient or
768 (b) extended period when a patient has reasonable cause to believe a professional
769 relationship exists between the person licensed or certified under the provisions of this chapter
- 25 - Senate Committee Amendments 2-13-2014Iplcjd
LEGISLA TIVE GENERAL COUNSEL SB138 ct Approved for Filing Sc Allred ct
ct 02-04-14 1220 PM ct
1 CONTROLLED SUBSTANCES ACT AMENDMENTS
2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Evan J Vickers
5 House Sponsor Stewart Barlow
6
7 LONG TITLE
8 General Description
9 This bill modifies the Utah Controlled Substances Act regarding prescriptions for
10 controlled substances
11 Highlighted Provisions
12 This bill
13 ~ provides that more than one controlled substance may be included in a prescription
14 Money Appropriated in this Bill
15 None
16 Other Special Clauses
17 None
18 Utah Code Sections Affected
19 AMENDS
20 58-37-6 as last amended by Laws of Utah 2012 Chapter 272
21
22 Be it enacted by the Legislature of the state ofUtah
23 Section 1 Section 58-37-6 is amended to read
24 58-37-6 License to manufacture produce distribute dispense administer or
25 conduct research -- Issuance by division -- Denial suspension or revocation -- Records
26
27
required -- Prescriptions
(1) (a) The division may adopt rules relating to the licensing and control of the bull
1111111111111111111111111111111111111111
SB138 02-04-14 1220 PM
214 (ii) the prescribed controlled substance is to be used in research
215 (f) Except when administered directly to an ultimate user by a licensed practitioner
216 controlled substances are subject to the following restrictions
217 (i) (A) A prescription for a Schedule IT substance may not be refilled
218 (B) A Schedule II controlled substance may not be filled in a quantity to exceed a
219 one-months supply as directed on the daily dosage rate of the prescriptions
220 (ii) A Schedule ill or IV controlled substance may be filled only within six months of
221 issuance and may not be refilled more than six months after the date of its original issuance or
222 be refilled more than five times after the date of the prescription unless renewed by the
223 practitioner
224 (iii) All other controlled substances in Schedule V may be refilled as the prescribers
225 prescription directs but they may not be refilled one year after the date the prescription was
226 issued unless renewed by the practitioner
227 (iv) Any prescription for a Schedule IT substance may not be dispensed if it is not
228 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days
229 after the date the prescription was issued or 30 days after the dispensing date if that date is
230 specified separately from the date of issue
231 (v) A practitioner may issue more than one prescription at the same time for the same
232 Schedule IT controlled substance but only under the following conditions
233 (A) no more than three prescriptions for the same Schedule IT controlled substance may
234 be issued at the same time
235 (B) no one prescription may exceed a 30-day supply
236 (C) a second or third prescription shall include the date of issuance and the date for
237 dispensing and
238 (D) unless the practitioner determines there is a valid medical reason to the contrary
239 the date for dispensing a second or third prescription may not be fewer than 30 days from the
240 dispensing date of the previous prescription
241 [(1i) Each prescription rot a controlled snbstance may eontain only one controlled
242 substance per pIescription frlim and may not contain any other legend dmg 01 prescription
243 item]
244 (g) An order for a controlled substance in Schedules IT through V for use by an
- 8 shy
LEGISLATIVE GENERAL COUNSEL it Approved for Filing CJ Dupont it
HB114
it 02-06-14855 AM it
1 MAIL-ORDER WHOLESALE DRUG AMENDMENTS 2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Stewart Barlow
5 Senate Sponsor ______
6
7 LONG TITLE
8 General Description
9 This bill amends the Pharmacy Practice Act
10 Highlighted Provisions
11 This bill
12 ~ amends the definition of a class C pharmacy subject to regulation under the
13 Pharmacy Practice Act
14 Money Appropriated in this Bill
15 None
16 Other Special Clauses
17 This bi II takes effect on July 1 2014
18 Utah Code Sections Affected
19 AMENDS
20 58-17b-102 as last amended by Laws of Utah 2013 Chapters 52 166 and 423
21
22 Be it enacted by the Legislature ofthe state ofUtah
23 Section 1 Section 58-17b-102 is amended to read
24 58-17b-102 Definitions
25 In addition to the definitions in Section 58-1-102 as used in this chapter
26
27
(1) Administering means
(a) the direct application of a prescription drug or device whether by injection
==bull =bull
1111111111111111111111111111111111111111
02-06-14855 AM HB114
59 (9) Centralized prescription processing means the processing by a pharmacy of a
60 request from another pharmacy to fill or refill a prescription drug order or to perform
61 processing functions such as dispensing drug utilization review claims adjudication refill
62 authorizations and therapeutic interventions
63 (10) Class A pharmacy means a pharmacy located in Utah that is authorized as a
64 retail pharmacy to compound or dispense a drug or dispense a device to the public under a
65 prescription order
66 (11) Class B pharmacy
67 (a) means a pharmacy located in Utah
68 (i) that is authorized to provide pharmaceutical care for patients in an institutional
69 setting and
70 (ii) whose primary purpose is to provide a physical environment for patients to obtain
71 health care services and
72 (b) (i) includes closed-door hospital clinic nuclear and branch pharmacies and
73 (ii) pharmaceutical administration and sterile product preparation facilities
74 (12) Class C pharmacy means a pharmacy [located ill Utah that is anthOl ized to
75 engage] that engages in the manufacture production wholesale or distribution of drugs or
76 devices in Utah
77 (13) Class D pharmacy means a nonresident pharmacy
78 (14) Class E pharmacy means all other pharmacies
79 (15) Closed-door pharmacy means a pharmacy that provides pharmaceutical care to a
80 defined and exclusive group of patients who have access to the services of the pharmacy
81 because they are treated by or have an affiliation with a specific entity including a health
82 maintenance organization or an infusion company but not including a hospital pharmacy a
83 retailer of goods to the general public or the office of a practitioner
84 (16) Collaborative pharmacy practice means a practice of pharmacy whereby one or
85 more pharmacists have jointly agreed on a voluntary basis to work in conjunction with one or
86 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical
87 care functions authorized by the practitioner or practitioners under certain specified conditions
88 or limitations
89 (17) Collaborative pharmacy practice agreement means a written and signed
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02-06-14855 AM HB114
369 and
370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in
371 collaboration with the board
372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501
373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and
374 may be further defined by rule
375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that
376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration
377 for animals
378 Section 2 Effective date
379 This bill takes effect on July I 2014
Legislative Review Note as of 2-4-14 1243 PM
Office of Legislative Research and General Counsel
- 13 shy
LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t
t 02-05-14 122PM t
1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG
2 AMENDMENTS
3 2014 GENERAL SESSION
4 STATE OF UTAH
5 Chief Sponsor Stewart Barlow
6 Senate Sponsor
7
8 LONG TITLE
9 General Description
10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from
11 its licensing requirements under certain circumstances
12 Highlighted Provisions
13 This bill
14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy
15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an
16 employer sponsored clinic and complies with other requirements
17 repeals subject to sunset review the provisions of this bill relating to the exemption
18 described above and
19 ~ makes technical and conforming changes
20 Money Appropriated in this Bill
21 None
22 Other Special Clauses
23 None
24 Utah Code Sections Affected
25 AMENDS
26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~
27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull
1111111111111111111111111111111111111111
HBI06 02-05-14 122 PM
28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278
29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234
30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351
31 ENACTS
32 58-17b-3097 Utah Code Annotated 1953
33
34 Be it enacted by the Legislature ofthe state ofUtah
35 Section 1 Section 58-17b-301 is amended to read
36 58-17b-301 License required -- License classifications for individuals
37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the
38 practice of a pharmacy technician except as specifically provided in Section 58-1-307
39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097
40 (2) The division shall issue to an individual who qualifies under this chapter a license
41 in the classification of
42 (a) pharmacist
43 (b) pharmacy intern or
44 (c) pharmacy technician
45 Section 2 Section 58-17b-302 is amended to read
46 58-17b-302 License required -- License classifications for pharmacy facilities
47 (l) A license is required to act as a pharmacy except as specifically exempted from
48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or
49
50 (2) The division shall issue a pharmacy license to a facility that qualifies under this
51 chapter in the classification of a
52 (a) class A pharmacy
53 (b) class B pharmacy
54 (c) class C pharmacy
55 (d) class D pharmacy or
56 (e) class E pharmacy
57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist
58 at the same address a separate license shall be required for each pharmacy
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02-05-14 122 PM HBI06
59 (4) The division may further define or supplement the classifications of pharmacies
60 The division may impose restrictions upon classifications to protect the public health safety
61 and welfare
62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by
63 rule
64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy
65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities
66 of the pharmacy regardless of the form of the business organization
67 Section 3 Section 58-17b-309 is amended to read
68 58-17b-309 Exemptions from licensure
69 (l) [For ptnp05C5 of] As used in this section
70 (a) Cosmetic drug
71 (i) means a prescription drug that is
72 (A) for the purpose of promoting attractiveness or altering the appearance of an
73 individual and
74 (8) listed as a cosmetic drug subject to the exemption under this section by the division
75 by administrative rule or has been expressly approved for online dispensing whether or not it is
76 dispensed online or through a physicians office and
77 (ii) does not include a prescription drug that is
78 (A) a controlled substance
79 (8) compounded by the physician or
80 (C) prescribed or used for the patient for the purpose of diagnosing curing or
81 preventing a disease
82 (b) Injectable weight loss drug
83 (i) means an injectable prescription drug
84 (A) prescribed to promote weight loss and
85 (8) listed as an injectable prescription drug subject to exemption under this section by
86 the division by administrative rule and
87 (ii) does not include a prescription drug that is a controlled substance
88 (c) Prescribing practitioner means an individual licensed under
89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with
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HB106 02-05-14 122 PM
90 prescriptive practice
91 (ii) Chapter 67 Utah Medical Practice Act
92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or
93 (iv) Chapter 70a Physician Assistant Act
94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l
95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the
96 acts or practices described in this section without being licensed under this chapter
97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the
98 individual notifies the division in writing of the individuals intent to dispense a drug under this
99 [snbsectioll] Subsection (2)
100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1
101 (c) an individual engaging in the practice of pharmacy technician under the direct
102 personal supervision of a pharmacist while making satisfactory progress in an approved
103 program as defined in division rule
104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an
105 injectable weight loss drug to the prescribing practitioners patient in accordance with
106 Subsection (4) or
107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists
108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic
109 drug to the optometrists patient in accordance with Subsection (4)
110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under
111 Subsection (2)( c) must take all examinations as required by division rule following completion
112 of an approved curriculum of education within the required time frame This exemption
113 expires immediately upon notification of a failing score of an examination and the individual
114 may not continue working as a pharmacy technician even under direct supervision
115 (4) A prescribing practitioner or optometrist is exempt from licensing under the
116 provisions of this part if the prescribing practitioner or optometrist
117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the
118 authority to dispense under Subsection (4)(b) and
119 (ii) informs the patient
120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing
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HB106 02-05-14 122 PM
152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the
153 prescribing practitioners or optometrists office and determine if the provisions of this section
154 are being met by the prescribing practitioner or optometrist
155 (d) If a prescribing practitioner or optometrist violates a provision of this section the
156 prescribing practitioner or optometrist may be subject to discipline under
157 (i) this chapter and
158 (ii) (A) Chapter 16a Utah Optometry Practice Act
159 (B) Chapter 31 b Nurse Practice Act
160 (C) Chapter 67 Utah Medical Practice Act
161 (D) Chapter 68 Utah Osteopathic Medical Practice Act
162 (E) Chapter 70a Physician Assistant Act or
163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act
164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the
165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah
166 Optometry Practice Act
167 Section 4 Section 58-17b-3095 is amended to read
168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy
169 Division study of dispensing practitioners
170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen
171 (a) means a prescription drug used to treat cancer manage its symptoms or provide
172 continuity of care for a cancer patient
173 (b) includes
174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal
175 methods and
176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize
177 physical and psychological symptoms or pain or to improve patient tolerance of cancer
178 treatments or prepare a patient for a subsequent course of therapy and
179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug
180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections
181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt
182 from licensure under this chapter
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HB106 02-05-14 122 PM
214 (ii) is acting under the direction of a prescribing practitioner who is immediately
215 available on site for any necessary consultation and who has complied with Subsection
216 (2)(b)(i)
217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the
218 outpatient clinic setting and
219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)
220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to
221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section
222 (b) The evaluation under this Subsection (3) shall include
223 (i) practitioner compliance with the requirements of this section and Section
224 58-l7b-309
225 (ii) current research on dispensing and patient safety
226 (iii) survey of other state dispensing laws and
227 (iv) recommendations for future action concerning practitioner dispensing
228 (c) The division shall report to the Legislatures Health and Human Services Interim
229 Committee by November 302012 and by November 302013 with the results and
230 recommendations from the evaluation required by this Subsection (3)
231 (4) This section sunsets in accordance with Section 631-1-258
232 Section 5 Section 58-17b-3097 is enacted to read
233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an
234 employer sponsored clinic
235 (1) As used in this section
236 (a) Employer sponsored clinic means an entity that offers health care only to the
237 employees of an exclusive group of employers and the employees dependents
238 (b) Health care is as defined in Section 31 A-J-301
239 (c) Prepackaged drug means a prescription drug that
240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and
241 (ii) is packaged in a fixed quantity per package by
242 (A) the drug manufacturer
243 (B) a pharmaceutical wholesaler or distributor or
244 (C) a pharmacy licensed under this title
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~ -- -------------------
02-05-14 122 PM HB106
245 Cd) Prescribing practitioner is as defined in Section 58-17b-309
246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309
247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing
248 requirements of this chapter if the prescribing practitioner
249 Ca) treats an employee of one of an exclusive group of employers at an employer
250 sponsored clinic
251 Cb) prescribes a prepackaged drug to the employee
252 Cc) dispenses the prepackaged drug at the employer sponsored clinic
253 (d) notifies the division
254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the
255 employer sponsored clinic and
256 (ii) of the drug the prescribing practitioner intends to dispense
257 Ce) determines that providing the prepackaged drug to the employee at the employer
258 sponsored clinic is in the employees best interest
259 (f) informs the employee
260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner
261 from a pharmacy that is unaffiliated with the prescribing practitioner
262 (ii) of the directions for appropriate use of the prepackaged drug
263 (iii) of potential side effects to the use of the prepackaged drug and
264 (iv) how to contact the prescribing practitioner if the employee has questions or
265 concerns regarding the drug
266 (g) offers the employee the opportunity to consult with a pharmacist if the employee
267 asks for patient counseling and
268 (h) follows the administrative rules for a prescribing practitioner at an employer
269 sponsored clinic established by the division under Subsection (4)
270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a
271 prepackaged drug under this section requires physician supervision in its scope ofpractice
272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the
273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter
274 68 Utah Osteopathic Medical Practice Act
275 (4) The division shall in consultation with the board of pharmacy and the Physicians
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HBI06 02-05-14 122 PM
276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title
277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping
278 patient counseling purchasing and distribution operating treatment quality of care and
279 storage requirements for a prescribing practitioner at an employer sponsored clinic
280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a
281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing
282 practitioner is in compliance with this section
283 (6) If a prescribing practitioner violates a provision of this section the prescribing
284 practitioner may be subject to discipline under
285 (a) this chapter and
286 (b) any other chapter that governs the terms of the prescribing practitioners license
287 (7) The division shall evaluate the exemption created by this section and report to the
288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1
289 2018 on the results of the evaluation and the divisions recommendations regarding the
290 exemption
291 Section 6 Section 631-1-258 is amended to read
292 631-1-258 Repeal dates Title 58
293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is
294 repealed July 12016
295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015
296 (3) Section 58-17b-3095 is repealed July 1 2015
297 (4) Section 58-17b-3097 is repealed on July 12018
298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1
299 2018
300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1
301 2023
302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing
303 Act is repealed July 1 2019
304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1
305 2015
306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is
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02-05-14 1 22 PM HB106
307 repealed July 12023
308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1
309 2014
310 [ttej] ill) Section 58-69-3025 is repealed on July 12015
311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017
Legislative Review Note as of 2-3-14 418 PM
Office of Legislative Research and General Counsel
- 11 shy
02-07-14 416 PM 1st Sub (Green) SB 55
615 Practitioner Clinic Pharmacy II
616 Section 8 Section 58-17b-802 is enacted to read
617 58-17b-802 Definitions
618 As used in this part
619 (1) (a) Cosmetic drug means a prescription drug that
620 (i) is for the purpose of promoting attractiveness or altering the appearance of an
621 individual and
622 (ii) (A) is listed as a cosmetic drug subject to the exemption under this section by the
623 division by administrative rule or
624 CB) has been expressly approved for online dispensing whether or not it is dispensed
625 online or through a physicians office
626 (b) Cosmetic drug does not include a prescription drug that is
627 (i) a controlled substance
628 (ii) compounded by the physician or
629 (iii) prescribed or used for the patient for the purpose of diagnosing curing or
630 preventing a disease
631 (2) Employer sponsored clinic means an entity that S-t has a medical director who is
631 a licensed as a physician as defined in Section 58-67-102 and S offers health care only to the
632 employees of an exclusive group of employers and the employees dependents
633 (3) Health care is as defined in Section 31A-1-301
634 (4) Ca) Injectable weight loss drug means an injectable prescription drug
635 (n prescribed to promote weight loss and
636 (ii) listed as an injectable prescription drug subject to exemption under this section by
637 the division by administrative rule
638 (b) Injectable weight loss drug does not include a prescription drug that is a
639 controlled substance
640 (5) Prepackaged drug means a prescription drug that
641 (a) is not listed under federal or state law as a Schedule I II ill IV or V drug and
642 (b) is packaged in a fixed quantity per package by
643 (i) the drug manufacturer
644 (ii) a pharmaceutical wholesaler or distributor or
645 (iii) a pharmacy licensed under this title
- 21 Senate Committee Amendments 2-13-2014 Jplcjd
1st Sub (Green) SB 55 02-07-14 416 PM
646 Section 9 Section 58-17b-803 is enacted to read
647 58-17b-803 Qualifications for licensure as a dispensing medical practitioner -shy
648 Scope of practice
649 (1) An applicant for a license as a dispensing medical practitioner shall
650 (a) be licensed in good standing under at least one of the chapters listed in Subsection
651 58-17b-l02(23)(a) and
652 (b) submit an application for a license as a dispensing medical practitioner in a form
653 prescribed by the division and pay a fee established by the S [depal tment] divisionS ~
654 (2) The division shall accept the licensing in good standing under Subsection (1) in lieu
655 of requiring an applicant for a license under this part to comply with Sections 58-17b-303 and
656
657 (3) A dispensing medical practitioner may dispense in accordance with this part
658 (a) a cosmetic drug and an injectable weight loss drug if
659 (i) the drug was prescribed by the dispensing medical practitioner to the dispensing
660 medical practitioners patient and
661 Oi) the dispensing medical practitioner complies with administrative rules adopted by
662 the division under Subsection 58-17-802(1)
663 (b) a cancer drug treatment regimen if the dispensing medical practitioner complies
664 with Section 58-17b-805 and
665 (c) a pre-packaged drug to an employee or a dependent of an employee at an employer
666 sponsored clinic if the dispensing medical practitioner
667 (i) treats an employee or the dependent of an employee of one of an exclusive group
668 of employers at an employer sponsored clinic
669 (ii) prescribes a prepackaged drug to the employee or the employees dependent
670 (iii) dispenses the prepackaged drug at the employer sponsored clinic and
671 (iv) complies with administrative rules adopted by the division in consultation with the
672 Board of Pharmacy that establish labeling record keeping patient counseling purchasing and
673 distribution operating treatment quality of care and storage requirements
674 (4) A dispensing medical practitioner
675 Ca) shall inform the patient
676 (i) that the drug dispensed by the practitioner may be obtained from a pharmacy
- 22 - Senate Committee Amendments 2-13-2014 picjd
02-07-14 416 PM 1st Sub (Green) SB 55
739 58-17b-806 Dispensing medical practitioner -- Dispensing medical practitioner
740 clinic pharmacy -- Unprofessional and Unlawful conduct
741 ill S Ull S The division S [ iii consultation witb tile boal d shall
742 (a) I epol t a violation of this chapter b a dispensing medical pi actitiollel to] shall consult
742a with S the
743 dispensing medical practitioners appropriate licensing board as designated in Subsection
744 5S-17b-l02(23)(a) S reeardine a violation oftMs chapterS and
745 (hl S the Pharmacy Board shall if requested by the licensine board of the dispensine
745a medical practitionerS assist the licensing board for the dispensing medical practitioner with
745b reviewing the
746 violations of the provisions of this chapter
747 (2) The division S [ in collabOi atioll with the Boal d ofPhall1l3C]S may take
747a appropriate
748 action against a dispensing medical practitioner in accordance with this chapter if the
749 licensing board designated in Subsection 58-17b- 02(23)(a) recommends to the division that
750 action be taken under this chapter
751 (3) The division in consultation with the board is the primary enforcer under this
752 chapter for a dispensing medical practitioner clinic pharmacy licensed under Section
753 58-17b-804
754 Section 13 Section 58-31b-502 is amended to read
755 58-31b-502 Unprofessional conduct
756 Unprofessional conduct includes
757 (l) failure to safeguard a patients right to privacy as to the patients person condition
758 diagnosis personal effects or any other matter about which the licensee is privileged to know
759 because of the licensees or person with a certifications position or practice as a nurse or
760 practice as a medication aide certified
761 (2) failure to provide nursing service or service as a medication aide certified in a
762 manner that demonstrates respect for the patients human dignity and unique personal character
763 and needs without regard to the patients race religion ethnic background socioeconomic
764 status age sex or the nature of the patients health problem
765 (3) engaging in sexual relations with a patient during any
766 (a) period when a generally recognized professional relationship exists between the
767 person licensed or certified under this chapter and patient or
768 (b) extended period when a patient has reasonable cause to believe a professional
769 relationship exists between the person licensed or certified under the provisions of this chapter
- 25 - Senate Committee Amendments 2-13-2014Iplcjd
LEGISLA TIVE GENERAL COUNSEL SB138 ct Approved for Filing Sc Allred ct
ct 02-04-14 1220 PM ct
1 CONTROLLED SUBSTANCES ACT AMENDMENTS
2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Evan J Vickers
5 House Sponsor Stewart Barlow
6
7 LONG TITLE
8 General Description
9 This bill modifies the Utah Controlled Substances Act regarding prescriptions for
10 controlled substances
11 Highlighted Provisions
12 This bill
13 ~ provides that more than one controlled substance may be included in a prescription
14 Money Appropriated in this Bill
15 None
16 Other Special Clauses
17 None
18 Utah Code Sections Affected
19 AMENDS
20 58-37-6 as last amended by Laws of Utah 2012 Chapter 272
21
22 Be it enacted by the Legislature of the state ofUtah
23 Section 1 Section 58-37-6 is amended to read
24 58-37-6 License to manufacture produce distribute dispense administer or
25 conduct research -- Issuance by division -- Denial suspension or revocation -- Records
26
27
required -- Prescriptions
(1) (a) The division may adopt rules relating to the licensing and control of the bull
1111111111111111111111111111111111111111
SB138 02-04-14 1220 PM
214 (ii) the prescribed controlled substance is to be used in research
215 (f) Except when administered directly to an ultimate user by a licensed practitioner
216 controlled substances are subject to the following restrictions
217 (i) (A) A prescription for a Schedule IT substance may not be refilled
218 (B) A Schedule II controlled substance may not be filled in a quantity to exceed a
219 one-months supply as directed on the daily dosage rate of the prescriptions
220 (ii) A Schedule ill or IV controlled substance may be filled only within six months of
221 issuance and may not be refilled more than six months after the date of its original issuance or
222 be refilled more than five times after the date of the prescription unless renewed by the
223 practitioner
224 (iii) All other controlled substances in Schedule V may be refilled as the prescribers
225 prescription directs but they may not be refilled one year after the date the prescription was
226 issued unless renewed by the practitioner
227 (iv) Any prescription for a Schedule IT substance may not be dispensed if it is not
228 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days
229 after the date the prescription was issued or 30 days after the dispensing date if that date is
230 specified separately from the date of issue
231 (v) A practitioner may issue more than one prescription at the same time for the same
232 Schedule IT controlled substance but only under the following conditions
233 (A) no more than three prescriptions for the same Schedule IT controlled substance may
234 be issued at the same time
235 (B) no one prescription may exceed a 30-day supply
236 (C) a second or third prescription shall include the date of issuance and the date for
237 dispensing and
238 (D) unless the practitioner determines there is a valid medical reason to the contrary
239 the date for dispensing a second or third prescription may not be fewer than 30 days from the
240 dispensing date of the previous prescription
241 [(1i) Each prescription rot a controlled snbstance may eontain only one controlled
242 substance per pIescription frlim and may not contain any other legend dmg 01 prescription
243 item]
244 (g) An order for a controlled substance in Schedules IT through V for use by an
- 8 shy
LEGISLATIVE GENERAL COUNSEL it Approved for Filing CJ Dupont it
HB114
it 02-06-14855 AM it
1 MAIL-ORDER WHOLESALE DRUG AMENDMENTS 2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Stewart Barlow
5 Senate Sponsor ______
6
7 LONG TITLE
8 General Description
9 This bill amends the Pharmacy Practice Act
10 Highlighted Provisions
11 This bill
12 ~ amends the definition of a class C pharmacy subject to regulation under the
13 Pharmacy Practice Act
14 Money Appropriated in this Bill
15 None
16 Other Special Clauses
17 This bi II takes effect on July 1 2014
18 Utah Code Sections Affected
19 AMENDS
20 58-17b-102 as last amended by Laws of Utah 2013 Chapters 52 166 and 423
21
22 Be it enacted by the Legislature ofthe state ofUtah
23 Section 1 Section 58-17b-102 is amended to read
24 58-17b-102 Definitions
25 In addition to the definitions in Section 58-1-102 as used in this chapter
26
27
(1) Administering means
(a) the direct application of a prescription drug or device whether by injection
==bull =bull
1111111111111111111111111111111111111111
02-06-14855 AM HB114
59 (9) Centralized prescription processing means the processing by a pharmacy of a
60 request from another pharmacy to fill or refill a prescription drug order or to perform
61 processing functions such as dispensing drug utilization review claims adjudication refill
62 authorizations and therapeutic interventions
63 (10) Class A pharmacy means a pharmacy located in Utah that is authorized as a
64 retail pharmacy to compound or dispense a drug or dispense a device to the public under a
65 prescription order
66 (11) Class B pharmacy
67 (a) means a pharmacy located in Utah
68 (i) that is authorized to provide pharmaceutical care for patients in an institutional
69 setting and
70 (ii) whose primary purpose is to provide a physical environment for patients to obtain
71 health care services and
72 (b) (i) includes closed-door hospital clinic nuclear and branch pharmacies and
73 (ii) pharmaceutical administration and sterile product preparation facilities
74 (12) Class C pharmacy means a pharmacy [located ill Utah that is anthOl ized to
75 engage] that engages in the manufacture production wholesale or distribution of drugs or
76 devices in Utah
77 (13) Class D pharmacy means a nonresident pharmacy
78 (14) Class E pharmacy means all other pharmacies
79 (15) Closed-door pharmacy means a pharmacy that provides pharmaceutical care to a
80 defined and exclusive group of patients who have access to the services of the pharmacy
81 because they are treated by or have an affiliation with a specific entity including a health
82 maintenance organization or an infusion company but not including a hospital pharmacy a
83 retailer of goods to the general public or the office of a practitioner
84 (16) Collaborative pharmacy practice means a practice of pharmacy whereby one or
85 more pharmacists have jointly agreed on a voluntary basis to work in conjunction with one or
86 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical
87 care functions authorized by the practitioner or practitioners under certain specified conditions
88 or limitations
89 (17) Collaborative pharmacy practice agreement means a written and signed
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02-06-14855 AM HB114
369 and
370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in
371 collaboration with the board
372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501
373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and
374 may be further defined by rule
375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that
376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration
377 for animals
378 Section 2 Effective date
379 This bill takes effect on July I 2014
Legislative Review Note as of 2-4-14 1243 PM
Office of Legislative Research and General Counsel
- 13 shy
LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t
t 02-05-14 122PM t
1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG
2 AMENDMENTS
3 2014 GENERAL SESSION
4 STATE OF UTAH
5 Chief Sponsor Stewart Barlow
6 Senate Sponsor
7
8 LONG TITLE
9 General Description
10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from
11 its licensing requirements under certain circumstances
12 Highlighted Provisions
13 This bill
14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy
15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an
16 employer sponsored clinic and complies with other requirements
17 repeals subject to sunset review the provisions of this bill relating to the exemption
18 described above and
19 ~ makes technical and conforming changes
20 Money Appropriated in this Bill
21 None
22 Other Special Clauses
23 None
24 Utah Code Sections Affected
25 AMENDS
26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~
27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull
1111111111111111111111111111111111111111
HBI06 02-05-14 122 PM
28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278
29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234
30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351
31 ENACTS
32 58-17b-3097 Utah Code Annotated 1953
33
34 Be it enacted by the Legislature ofthe state ofUtah
35 Section 1 Section 58-17b-301 is amended to read
36 58-17b-301 License required -- License classifications for individuals
37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the
38 practice of a pharmacy technician except as specifically provided in Section 58-1-307
39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097
40 (2) The division shall issue to an individual who qualifies under this chapter a license
41 in the classification of
42 (a) pharmacist
43 (b) pharmacy intern or
44 (c) pharmacy technician
45 Section 2 Section 58-17b-302 is amended to read
46 58-17b-302 License required -- License classifications for pharmacy facilities
47 (l) A license is required to act as a pharmacy except as specifically exempted from
48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or
49
50 (2) The division shall issue a pharmacy license to a facility that qualifies under this
51 chapter in the classification of a
52 (a) class A pharmacy
53 (b) class B pharmacy
54 (c) class C pharmacy
55 (d) class D pharmacy or
56 (e) class E pharmacy
57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist
58 at the same address a separate license shall be required for each pharmacy
-2shy
02-05-14 122 PM HBI06
59 (4) The division may further define or supplement the classifications of pharmacies
60 The division may impose restrictions upon classifications to protect the public health safety
61 and welfare
62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by
63 rule
64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy
65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities
66 of the pharmacy regardless of the form of the business organization
67 Section 3 Section 58-17b-309 is amended to read
68 58-17b-309 Exemptions from licensure
69 (l) [For ptnp05C5 of] As used in this section
70 (a) Cosmetic drug
71 (i) means a prescription drug that is
72 (A) for the purpose of promoting attractiveness or altering the appearance of an
73 individual and
74 (8) listed as a cosmetic drug subject to the exemption under this section by the division
75 by administrative rule or has been expressly approved for online dispensing whether or not it is
76 dispensed online or through a physicians office and
77 (ii) does not include a prescription drug that is
78 (A) a controlled substance
79 (8) compounded by the physician or
80 (C) prescribed or used for the patient for the purpose of diagnosing curing or
81 preventing a disease
82 (b) Injectable weight loss drug
83 (i) means an injectable prescription drug
84 (A) prescribed to promote weight loss and
85 (8) listed as an injectable prescription drug subject to exemption under this section by
86 the division by administrative rule and
87 (ii) does not include a prescription drug that is a controlled substance
88 (c) Prescribing practitioner means an individual licensed under
89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with
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HB106 02-05-14 122 PM
90 prescriptive practice
91 (ii) Chapter 67 Utah Medical Practice Act
92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or
93 (iv) Chapter 70a Physician Assistant Act
94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l
95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the
96 acts or practices described in this section without being licensed under this chapter
97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the
98 individual notifies the division in writing of the individuals intent to dispense a drug under this
99 [snbsectioll] Subsection (2)
100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1
101 (c) an individual engaging in the practice of pharmacy technician under the direct
102 personal supervision of a pharmacist while making satisfactory progress in an approved
103 program as defined in division rule
104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an
105 injectable weight loss drug to the prescribing practitioners patient in accordance with
106 Subsection (4) or
107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists
108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic
109 drug to the optometrists patient in accordance with Subsection (4)
110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under
111 Subsection (2)( c) must take all examinations as required by division rule following completion
112 of an approved curriculum of education within the required time frame This exemption
113 expires immediately upon notification of a failing score of an examination and the individual
114 may not continue working as a pharmacy technician even under direct supervision
115 (4) A prescribing practitioner or optometrist is exempt from licensing under the
116 provisions of this part if the prescribing practitioner or optometrist
117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the
118 authority to dispense under Subsection (4)(b) and
119 (ii) informs the patient
120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing
-4shy
HB106 02-05-14 122 PM
152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the
153 prescribing practitioners or optometrists office and determine if the provisions of this section
154 are being met by the prescribing practitioner or optometrist
155 (d) If a prescribing practitioner or optometrist violates a provision of this section the
156 prescribing practitioner or optometrist may be subject to discipline under
157 (i) this chapter and
158 (ii) (A) Chapter 16a Utah Optometry Practice Act
159 (B) Chapter 31 b Nurse Practice Act
160 (C) Chapter 67 Utah Medical Practice Act
161 (D) Chapter 68 Utah Osteopathic Medical Practice Act
162 (E) Chapter 70a Physician Assistant Act or
163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act
164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the
165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah
166 Optometry Practice Act
167 Section 4 Section 58-17b-3095 is amended to read
168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy
169 Division study of dispensing practitioners
170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen
171 (a) means a prescription drug used to treat cancer manage its symptoms or provide
172 continuity of care for a cancer patient
173 (b) includes
174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal
175 methods and
176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize
177 physical and psychological symptoms or pain or to improve patient tolerance of cancer
178 treatments or prepare a patient for a subsequent course of therapy and
179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug
180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections
181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt
182 from licensure under this chapter
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HB106 02-05-14 122 PM
214 (ii) is acting under the direction of a prescribing practitioner who is immediately
215 available on site for any necessary consultation and who has complied with Subsection
216 (2)(b)(i)
217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the
218 outpatient clinic setting and
219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)
220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to
221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section
222 (b) The evaluation under this Subsection (3) shall include
223 (i) practitioner compliance with the requirements of this section and Section
224 58-l7b-309
225 (ii) current research on dispensing and patient safety
226 (iii) survey of other state dispensing laws and
227 (iv) recommendations for future action concerning practitioner dispensing
228 (c) The division shall report to the Legislatures Health and Human Services Interim
229 Committee by November 302012 and by November 302013 with the results and
230 recommendations from the evaluation required by this Subsection (3)
231 (4) This section sunsets in accordance with Section 631-1-258
232 Section 5 Section 58-17b-3097 is enacted to read
233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an
234 employer sponsored clinic
235 (1) As used in this section
236 (a) Employer sponsored clinic means an entity that offers health care only to the
237 employees of an exclusive group of employers and the employees dependents
238 (b) Health care is as defined in Section 31 A-J-301
239 (c) Prepackaged drug means a prescription drug that
240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and
241 (ii) is packaged in a fixed quantity per package by
242 (A) the drug manufacturer
243 (B) a pharmaceutical wholesaler or distributor or
244 (C) a pharmacy licensed under this title
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~ -- -------------------
02-05-14 122 PM HB106
245 Cd) Prescribing practitioner is as defined in Section 58-17b-309
246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309
247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing
248 requirements of this chapter if the prescribing practitioner
249 Ca) treats an employee of one of an exclusive group of employers at an employer
250 sponsored clinic
251 Cb) prescribes a prepackaged drug to the employee
252 Cc) dispenses the prepackaged drug at the employer sponsored clinic
253 (d) notifies the division
254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the
255 employer sponsored clinic and
256 (ii) of the drug the prescribing practitioner intends to dispense
257 Ce) determines that providing the prepackaged drug to the employee at the employer
258 sponsored clinic is in the employees best interest
259 (f) informs the employee
260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner
261 from a pharmacy that is unaffiliated with the prescribing practitioner
262 (ii) of the directions for appropriate use of the prepackaged drug
263 (iii) of potential side effects to the use of the prepackaged drug and
264 (iv) how to contact the prescribing practitioner if the employee has questions or
265 concerns regarding the drug
266 (g) offers the employee the opportunity to consult with a pharmacist if the employee
267 asks for patient counseling and
268 (h) follows the administrative rules for a prescribing practitioner at an employer
269 sponsored clinic established by the division under Subsection (4)
270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a
271 prepackaged drug under this section requires physician supervision in its scope ofpractice
272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the
273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter
274 68 Utah Osteopathic Medical Practice Act
275 (4) The division shall in consultation with the board of pharmacy and the Physicians
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HBI06 02-05-14 122 PM
276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title
277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping
278 patient counseling purchasing and distribution operating treatment quality of care and
279 storage requirements for a prescribing practitioner at an employer sponsored clinic
280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a
281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing
282 practitioner is in compliance with this section
283 (6) If a prescribing practitioner violates a provision of this section the prescribing
284 practitioner may be subject to discipline under
285 (a) this chapter and
286 (b) any other chapter that governs the terms of the prescribing practitioners license
287 (7) The division shall evaluate the exemption created by this section and report to the
288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1
289 2018 on the results of the evaluation and the divisions recommendations regarding the
290 exemption
291 Section 6 Section 631-1-258 is amended to read
292 631-1-258 Repeal dates Title 58
293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is
294 repealed July 12016
295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015
296 (3) Section 58-17b-3095 is repealed July 1 2015
297 (4) Section 58-17b-3097 is repealed on July 12018
298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1
299 2018
300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1
301 2023
302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing
303 Act is repealed July 1 2019
304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1
305 2015
306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is
- 10shy
02-05-14 1 22 PM HB106
307 repealed July 12023
308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1
309 2014
310 [ttej] ill) Section 58-69-3025 is repealed on July 12015
311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017
Legislative Review Note as of 2-3-14 418 PM
Office of Legislative Research and General Counsel
- 11 shy
1st Sub (Green) SB 55 02-07-14 416 PM
646 Section 9 Section 58-17b-803 is enacted to read
647 58-17b-803 Qualifications for licensure as a dispensing medical practitioner -shy
648 Scope of practice
649 (1) An applicant for a license as a dispensing medical practitioner shall
650 (a) be licensed in good standing under at least one of the chapters listed in Subsection
651 58-17b-l02(23)(a) and
652 (b) submit an application for a license as a dispensing medical practitioner in a form
653 prescribed by the division and pay a fee established by the S [depal tment] divisionS ~
654 (2) The division shall accept the licensing in good standing under Subsection (1) in lieu
655 of requiring an applicant for a license under this part to comply with Sections 58-17b-303 and
656
657 (3) A dispensing medical practitioner may dispense in accordance with this part
658 (a) a cosmetic drug and an injectable weight loss drug if
659 (i) the drug was prescribed by the dispensing medical practitioner to the dispensing
660 medical practitioners patient and
661 Oi) the dispensing medical practitioner complies with administrative rules adopted by
662 the division under Subsection 58-17-802(1)
663 (b) a cancer drug treatment regimen if the dispensing medical practitioner complies
664 with Section 58-17b-805 and
665 (c) a pre-packaged drug to an employee or a dependent of an employee at an employer
666 sponsored clinic if the dispensing medical practitioner
667 (i) treats an employee or the dependent of an employee of one of an exclusive group
668 of employers at an employer sponsored clinic
669 (ii) prescribes a prepackaged drug to the employee or the employees dependent
670 (iii) dispenses the prepackaged drug at the employer sponsored clinic and
671 (iv) complies with administrative rules adopted by the division in consultation with the
672 Board of Pharmacy that establish labeling record keeping patient counseling purchasing and
673 distribution operating treatment quality of care and storage requirements
674 (4) A dispensing medical practitioner
675 Ca) shall inform the patient
676 (i) that the drug dispensed by the practitioner may be obtained from a pharmacy
- 22 - Senate Committee Amendments 2-13-2014 picjd
02-07-14 416 PM 1st Sub (Green) SB 55
739 58-17b-806 Dispensing medical practitioner -- Dispensing medical practitioner
740 clinic pharmacy -- Unprofessional and Unlawful conduct
741 ill S Ull S The division S [ iii consultation witb tile boal d shall
742 (a) I epol t a violation of this chapter b a dispensing medical pi actitiollel to] shall consult
742a with S the
743 dispensing medical practitioners appropriate licensing board as designated in Subsection
744 5S-17b-l02(23)(a) S reeardine a violation oftMs chapterS and
745 (hl S the Pharmacy Board shall if requested by the licensine board of the dispensine
745a medical practitionerS assist the licensing board for the dispensing medical practitioner with
745b reviewing the
746 violations of the provisions of this chapter
747 (2) The division S [ in collabOi atioll with the Boal d ofPhall1l3C]S may take
747a appropriate
748 action against a dispensing medical practitioner in accordance with this chapter if the
749 licensing board designated in Subsection 58-17b- 02(23)(a) recommends to the division that
750 action be taken under this chapter
751 (3) The division in consultation with the board is the primary enforcer under this
752 chapter for a dispensing medical practitioner clinic pharmacy licensed under Section
753 58-17b-804
754 Section 13 Section 58-31b-502 is amended to read
755 58-31b-502 Unprofessional conduct
756 Unprofessional conduct includes
757 (l) failure to safeguard a patients right to privacy as to the patients person condition
758 diagnosis personal effects or any other matter about which the licensee is privileged to know
759 because of the licensees or person with a certifications position or practice as a nurse or
760 practice as a medication aide certified
761 (2) failure to provide nursing service or service as a medication aide certified in a
762 manner that demonstrates respect for the patients human dignity and unique personal character
763 and needs without regard to the patients race religion ethnic background socioeconomic
764 status age sex or the nature of the patients health problem
765 (3) engaging in sexual relations with a patient during any
766 (a) period when a generally recognized professional relationship exists between the
767 person licensed or certified under this chapter and patient or
768 (b) extended period when a patient has reasonable cause to believe a professional
769 relationship exists between the person licensed or certified under the provisions of this chapter
- 25 - Senate Committee Amendments 2-13-2014Iplcjd
LEGISLA TIVE GENERAL COUNSEL SB138 ct Approved for Filing Sc Allred ct
ct 02-04-14 1220 PM ct
1 CONTROLLED SUBSTANCES ACT AMENDMENTS
2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Evan J Vickers
5 House Sponsor Stewart Barlow
6
7 LONG TITLE
8 General Description
9 This bill modifies the Utah Controlled Substances Act regarding prescriptions for
10 controlled substances
11 Highlighted Provisions
12 This bill
13 ~ provides that more than one controlled substance may be included in a prescription
14 Money Appropriated in this Bill
15 None
16 Other Special Clauses
17 None
18 Utah Code Sections Affected
19 AMENDS
20 58-37-6 as last amended by Laws of Utah 2012 Chapter 272
21
22 Be it enacted by the Legislature of the state ofUtah
23 Section 1 Section 58-37-6 is amended to read
24 58-37-6 License to manufacture produce distribute dispense administer or
25 conduct research -- Issuance by division -- Denial suspension or revocation -- Records
26
27
required -- Prescriptions
(1) (a) The division may adopt rules relating to the licensing and control of the bull
1111111111111111111111111111111111111111
SB138 02-04-14 1220 PM
214 (ii) the prescribed controlled substance is to be used in research
215 (f) Except when administered directly to an ultimate user by a licensed practitioner
216 controlled substances are subject to the following restrictions
217 (i) (A) A prescription for a Schedule IT substance may not be refilled
218 (B) A Schedule II controlled substance may not be filled in a quantity to exceed a
219 one-months supply as directed on the daily dosage rate of the prescriptions
220 (ii) A Schedule ill or IV controlled substance may be filled only within six months of
221 issuance and may not be refilled more than six months after the date of its original issuance or
222 be refilled more than five times after the date of the prescription unless renewed by the
223 practitioner
224 (iii) All other controlled substances in Schedule V may be refilled as the prescribers
225 prescription directs but they may not be refilled one year after the date the prescription was
226 issued unless renewed by the practitioner
227 (iv) Any prescription for a Schedule IT substance may not be dispensed if it is not
228 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days
229 after the date the prescription was issued or 30 days after the dispensing date if that date is
230 specified separately from the date of issue
231 (v) A practitioner may issue more than one prescription at the same time for the same
232 Schedule IT controlled substance but only under the following conditions
233 (A) no more than three prescriptions for the same Schedule IT controlled substance may
234 be issued at the same time
235 (B) no one prescription may exceed a 30-day supply
236 (C) a second or third prescription shall include the date of issuance and the date for
237 dispensing and
238 (D) unless the practitioner determines there is a valid medical reason to the contrary
239 the date for dispensing a second or third prescription may not be fewer than 30 days from the
240 dispensing date of the previous prescription
241 [(1i) Each prescription rot a controlled snbstance may eontain only one controlled
242 substance per pIescription frlim and may not contain any other legend dmg 01 prescription
243 item]
244 (g) An order for a controlled substance in Schedules IT through V for use by an
- 8 shy
LEGISLATIVE GENERAL COUNSEL it Approved for Filing CJ Dupont it
HB114
it 02-06-14855 AM it
1 MAIL-ORDER WHOLESALE DRUG AMENDMENTS 2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Stewart Barlow
5 Senate Sponsor ______
6
7 LONG TITLE
8 General Description
9 This bill amends the Pharmacy Practice Act
10 Highlighted Provisions
11 This bill
12 ~ amends the definition of a class C pharmacy subject to regulation under the
13 Pharmacy Practice Act
14 Money Appropriated in this Bill
15 None
16 Other Special Clauses
17 This bi II takes effect on July 1 2014
18 Utah Code Sections Affected
19 AMENDS
20 58-17b-102 as last amended by Laws of Utah 2013 Chapters 52 166 and 423
21
22 Be it enacted by the Legislature ofthe state ofUtah
23 Section 1 Section 58-17b-102 is amended to read
24 58-17b-102 Definitions
25 In addition to the definitions in Section 58-1-102 as used in this chapter
26
27
(1) Administering means
(a) the direct application of a prescription drug or device whether by injection
==bull =bull
1111111111111111111111111111111111111111
02-06-14855 AM HB114
59 (9) Centralized prescription processing means the processing by a pharmacy of a
60 request from another pharmacy to fill or refill a prescription drug order or to perform
61 processing functions such as dispensing drug utilization review claims adjudication refill
62 authorizations and therapeutic interventions
63 (10) Class A pharmacy means a pharmacy located in Utah that is authorized as a
64 retail pharmacy to compound or dispense a drug or dispense a device to the public under a
65 prescription order
66 (11) Class B pharmacy
67 (a) means a pharmacy located in Utah
68 (i) that is authorized to provide pharmaceutical care for patients in an institutional
69 setting and
70 (ii) whose primary purpose is to provide a physical environment for patients to obtain
71 health care services and
72 (b) (i) includes closed-door hospital clinic nuclear and branch pharmacies and
73 (ii) pharmaceutical administration and sterile product preparation facilities
74 (12) Class C pharmacy means a pharmacy [located ill Utah that is anthOl ized to
75 engage] that engages in the manufacture production wholesale or distribution of drugs or
76 devices in Utah
77 (13) Class D pharmacy means a nonresident pharmacy
78 (14) Class E pharmacy means all other pharmacies
79 (15) Closed-door pharmacy means a pharmacy that provides pharmaceutical care to a
80 defined and exclusive group of patients who have access to the services of the pharmacy
81 because they are treated by or have an affiliation with a specific entity including a health
82 maintenance organization or an infusion company but not including a hospital pharmacy a
83 retailer of goods to the general public or the office of a practitioner
84 (16) Collaborative pharmacy practice means a practice of pharmacy whereby one or
85 more pharmacists have jointly agreed on a voluntary basis to work in conjunction with one or
86 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical
87 care functions authorized by the practitioner or practitioners under certain specified conditions
88 or limitations
89 (17) Collaborative pharmacy practice agreement means a written and signed
- 3 shy
02-06-14855 AM HB114
369 and
370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in
371 collaboration with the board
372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501
373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and
374 may be further defined by rule
375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that
376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration
377 for animals
378 Section 2 Effective date
379 This bill takes effect on July I 2014
Legislative Review Note as of 2-4-14 1243 PM
Office of Legislative Research and General Counsel
- 13 shy
LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t
t 02-05-14 122PM t
1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG
2 AMENDMENTS
3 2014 GENERAL SESSION
4 STATE OF UTAH
5 Chief Sponsor Stewart Barlow
6 Senate Sponsor
7
8 LONG TITLE
9 General Description
10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from
11 its licensing requirements under certain circumstances
12 Highlighted Provisions
13 This bill
14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy
15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an
16 employer sponsored clinic and complies with other requirements
17 repeals subject to sunset review the provisions of this bill relating to the exemption
18 described above and
19 ~ makes technical and conforming changes
20 Money Appropriated in this Bill
21 None
22 Other Special Clauses
23 None
24 Utah Code Sections Affected
25 AMENDS
26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~
27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull
1111111111111111111111111111111111111111
HBI06 02-05-14 122 PM
28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278
29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234
30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351
31 ENACTS
32 58-17b-3097 Utah Code Annotated 1953
33
34 Be it enacted by the Legislature ofthe state ofUtah
35 Section 1 Section 58-17b-301 is amended to read
36 58-17b-301 License required -- License classifications for individuals
37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the
38 practice of a pharmacy technician except as specifically provided in Section 58-1-307
39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097
40 (2) The division shall issue to an individual who qualifies under this chapter a license
41 in the classification of
42 (a) pharmacist
43 (b) pharmacy intern or
44 (c) pharmacy technician
45 Section 2 Section 58-17b-302 is amended to read
46 58-17b-302 License required -- License classifications for pharmacy facilities
47 (l) A license is required to act as a pharmacy except as specifically exempted from
48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or
49
50 (2) The division shall issue a pharmacy license to a facility that qualifies under this
51 chapter in the classification of a
52 (a) class A pharmacy
53 (b) class B pharmacy
54 (c) class C pharmacy
55 (d) class D pharmacy or
56 (e) class E pharmacy
57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist
58 at the same address a separate license shall be required for each pharmacy
-2shy
02-05-14 122 PM HBI06
59 (4) The division may further define or supplement the classifications of pharmacies
60 The division may impose restrictions upon classifications to protect the public health safety
61 and welfare
62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by
63 rule
64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy
65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities
66 of the pharmacy regardless of the form of the business organization
67 Section 3 Section 58-17b-309 is amended to read
68 58-17b-309 Exemptions from licensure
69 (l) [For ptnp05C5 of] As used in this section
70 (a) Cosmetic drug
71 (i) means a prescription drug that is
72 (A) for the purpose of promoting attractiveness or altering the appearance of an
73 individual and
74 (8) listed as a cosmetic drug subject to the exemption under this section by the division
75 by administrative rule or has been expressly approved for online dispensing whether or not it is
76 dispensed online or through a physicians office and
77 (ii) does not include a prescription drug that is
78 (A) a controlled substance
79 (8) compounded by the physician or
80 (C) prescribed or used for the patient for the purpose of diagnosing curing or
81 preventing a disease
82 (b) Injectable weight loss drug
83 (i) means an injectable prescription drug
84 (A) prescribed to promote weight loss and
85 (8) listed as an injectable prescription drug subject to exemption under this section by
86 the division by administrative rule and
87 (ii) does not include a prescription drug that is a controlled substance
88 (c) Prescribing practitioner means an individual licensed under
89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with
- 3 shy
HB106 02-05-14 122 PM
90 prescriptive practice
91 (ii) Chapter 67 Utah Medical Practice Act
92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or
93 (iv) Chapter 70a Physician Assistant Act
94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l
95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the
96 acts or practices described in this section without being licensed under this chapter
97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the
98 individual notifies the division in writing of the individuals intent to dispense a drug under this
99 [snbsectioll] Subsection (2)
100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1
101 (c) an individual engaging in the practice of pharmacy technician under the direct
102 personal supervision of a pharmacist while making satisfactory progress in an approved
103 program as defined in division rule
104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an
105 injectable weight loss drug to the prescribing practitioners patient in accordance with
106 Subsection (4) or
107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists
108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic
109 drug to the optometrists patient in accordance with Subsection (4)
110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under
111 Subsection (2)( c) must take all examinations as required by division rule following completion
112 of an approved curriculum of education within the required time frame This exemption
113 expires immediately upon notification of a failing score of an examination and the individual
114 may not continue working as a pharmacy technician even under direct supervision
115 (4) A prescribing practitioner or optometrist is exempt from licensing under the
116 provisions of this part if the prescribing practitioner or optometrist
117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the
118 authority to dispense under Subsection (4)(b) and
119 (ii) informs the patient
120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing
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HB106 02-05-14 122 PM
152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the
153 prescribing practitioners or optometrists office and determine if the provisions of this section
154 are being met by the prescribing practitioner or optometrist
155 (d) If a prescribing practitioner or optometrist violates a provision of this section the
156 prescribing practitioner or optometrist may be subject to discipline under
157 (i) this chapter and
158 (ii) (A) Chapter 16a Utah Optometry Practice Act
159 (B) Chapter 31 b Nurse Practice Act
160 (C) Chapter 67 Utah Medical Practice Act
161 (D) Chapter 68 Utah Osteopathic Medical Practice Act
162 (E) Chapter 70a Physician Assistant Act or
163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act
164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the
165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah
166 Optometry Practice Act
167 Section 4 Section 58-17b-3095 is amended to read
168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy
169 Division study of dispensing practitioners
170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen
171 (a) means a prescription drug used to treat cancer manage its symptoms or provide
172 continuity of care for a cancer patient
173 (b) includes
174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal
175 methods and
176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize
177 physical and psychological symptoms or pain or to improve patient tolerance of cancer
178 treatments or prepare a patient for a subsequent course of therapy and
179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug
180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections
181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt
182 from licensure under this chapter
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HB106 02-05-14 122 PM
214 (ii) is acting under the direction of a prescribing practitioner who is immediately
215 available on site for any necessary consultation and who has complied with Subsection
216 (2)(b)(i)
217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the
218 outpatient clinic setting and
219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)
220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to
221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section
222 (b) The evaluation under this Subsection (3) shall include
223 (i) practitioner compliance with the requirements of this section and Section
224 58-l7b-309
225 (ii) current research on dispensing and patient safety
226 (iii) survey of other state dispensing laws and
227 (iv) recommendations for future action concerning practitioner dispensing
228 (c) The division shall report to the Legislatures Health and Human Services Interim
229 Committee by November 302012 and by November 302013 with the results and
230 recommendations from the evaluation required by this Subsection (3)
231 (4) This section sunsets in accordance with Section 631-1-258
232 Section 5 Section 58-17b-3097 is enacted to read
233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an
234 employer sponsored clinic
235 (1) As used in this section
236 (a) Employer sponsored clinic means an entity that offers health care only to the
237 employees of an exclusive group of employers and the employees dependents
238 (b) Health care is as defined in Section 31 A-J-301
239 (c) Prepackaged drug means a prescription drug that
240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and
241 (ii) is packaged in a fixed quantity per package by
242 (A) the drug manufacturer
243 (B) a pharmaceutical wholesaler or distributor or
244 (C) a pharmacy licensed under this title
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~ -- -------------------
02-05-14 122 PM HB106
245 Cd) Prescribing practitioner is as defined in Section 58-17b-309
246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309
247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing
248 requirements of this chapter if the prescribing practitioner
249 Ca) treats an employee of one of an exclusive group of employers at an employer
250 sponsored clinic
251 Cb) prescribes a prepackaged drug to the employee
252 Cc) dispenses the prepackaged drug at the employer sponsored clinic
253 (d) notifies the division
254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the
255 employer sponsored clinic and
256 (ii) of the drug the prescribing practitioner intends to dispense
257 Ce) determines that providing the prepackaged drug to the employee at the employer
258 sponsored clinic is in the employees best interest
259 (f) informs the employee
260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner
261 from a pharmacy that is unaffiliated with the prescribing practitioner
262 (ii) of the directions for appropriate use of the prepackaged drug
263 (iii) of potential side effects to the use of the prepackaged drug and
264 (iv) how to contact the prescribing practitioner if the employee has questions or
265 concerns regarding the drug
266 (g) offers the employee the opportunity to consult with a pharmacist if the employee
267 asks for patient counseling and
268 (h) follows the administrative rules for a prescribing practitioner at an employer
269 sponsored clinic established by the division under Subsection (4)
270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a
271 prepackaged drug under this section requires physician supervision in its scope ofpractice
272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the
273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter
274 68 Utah Osteopathic Medical Practice Act
275 (4) The division shall in consultation with the board of pharmacy and the Physicians
- 9 shy
HBI06 02-05-14 122 PM
276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title
277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping
278 patient counseling purchasing and distribution operating treatment quality of care and
279 storage requirements for a prescribing practitioner at an employer sponsored clinic
280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a
281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing
282 practitioner is in compliance with this section
283 (6) If a prescribing practitioner violates a provision of this section the prescribing
284 practitioner may be subject to discipline under
285 (a) this chapter and
286 (b) any other chapter that governs the terms of the prescribing practitioners license
287 (7) The division shall evaluate the exemption created by this section and report to the
288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1
289 2018 on the results of the evaluation and the divisions recommendations regarding the
290 exemption
291 Section 6 Section 631-1-258 is amended to read
292 631-1-258 Repeal dates Title 58
293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is
294 repealed July 12016
295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015
296 (3) Section 58-17b-3095 is repealed July 1 2015
297 (4) Section 58-17b-3097 is repealed on July 12018
298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1
299 2018
300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1
301 2023
302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing
303 Act is repealed July 1 2019
304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1
305 2015
306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is
- 10shy
02-05-14 1 22 PM HB106
307 repealed July 12023
308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1
309 2014
310 [ttej] ill) Section 58-69-3025 is repealed on July 12015
311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017
Legislative Review Note as of 2-3-14 418 PM
Office of Legislative Research and General Counsel
- 11 shy
02-07-14 416 PM 1st Sub (Green) SB 55
739 58-17b-806 Dispensing medical practitioner -- Dispensing medical practitioner
740 clinic pharmacy -- Unprofessional and Unlawful conduct
741 ill S Ull S The division S [ iii consultation witb tile boal d shall
742 (a) I epol t a violation of this chapter b a dispensing medical pi actitiollel to] shall consult
742a with S the
743 dispensing medical practitioners appropriate licensing board as designated in Subsection
744 5S-17b-l02(23)(a) S reeardine a violation oftMs chapterS and
745 (hl S the Pharmacy Board shall if requested by the licensine board of the dispensine
745a medical practitionerS assist the licensing board for the dispensing medical practitioner with
745b reviewing the
746 violations of the provisions of this chapter
747 (2) The division S [ in collabOi atioll with the Boal d ofPhall1l3C]S may take
747a appropriate
748 action against a dispensing medical practitioner in accordance with this chapter if the
749 licensing board designated in Subsection 58-17b- 02(23)(a) recommends to the division that
750 action be taken under this chapter
751 (3) The division in consultation with the board is the primary enforcer under this
752 chapter for a dispensing medical practitioner clinic pharmacy licensed under Section
753 58-17b-804
754 Section 13 Section 58-31b-502 is amended to read
755 58-31b-502 Unprofessional conduct
756 Unprofessional conduct includes
757 (l) failure to safeguard a patients right to privacy as to the patients person condition
758 diagnosis personal effects or any other matter about which the licensee is privileged to know
759 because of the licensees or person with a certifications position or practice as a nurse or
760 practice as a medication aide certified
761 (2) failure to provide nursing service or service as a medication aide certified in a
762 manner that demonstrates respect for the patients human dignity and unique personal character
763 and needs without regard to the patients race religion ethnic background socioeconomic
764 status age sex or the nature of the patients health problem
765 (3) engaging in sexual relations with a patient during any
766 (a) period when a generally recognized professional relationship exists between the
767 person licensed or certified under this chapter and patient or
768 (b) extended period when a patient has reasonable cause to believe a professional
769 relationship exists between the person licensed or certified under the provisions of this chapter
- 25 - Senate Committee Amendments 2-13-2014Iplcjd
LEGISLA TIVE GENERAL COUNSEL SB138 ct Approved for Filing Sc Allred ct
ct 02-04-14 1220 PM ct
1 CONTROLLED SUBSTANCES ACT AMENDMENTS
2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Evan J Vickers
5 House Sponsor Stewart Barlow
6
7 LONG TITLE
8 General Description
9 This bill modifies the Utah Controlled Substances Act regarding prescriptions for
10 controlled substances
11 Highlighted Provisions
12 This bill
13 ~ provides that more than one controlled substance may be included in a prescription
14 Money Appropriated in this Bill
15 None
16 Other Special Clauses
17 None
18 Utah Code Sections Affected
19 AMENDS
20 58-37-6 as last amended by Laws of Utah 2012 Chapter 272
21
22 Be it enacted by the Legislature of the state ofUtah
23 Section 1 Section 58-37-6 is amended to read
24 58-37-6 License to manufacture produce distribute dispense administer or
25 conduct research -- Issuance by division -- Denial suspension or revocation -- Records
26
27
required -- Prescriptions
(1) (a) The division may adopt rules relating to the licensing and control of the bull
1111111111111111111111111111111111111111
SB138 02-04-14 1220 PM
214 (ii) the prescribed controlled substance is to be used in research
215 (f) Except when administered directly to an ultimate user by a licensed practitioner
216 controlled substances are subject to the following restrictions
217 (i) (A) A prescription for a Schedule IT substance may not be refilled
218 (B) A Schedule II controlled substance may not be filled in a quantity to exceed a
219 one-months supply as directed on the daily dosage rate of the prescriptions
220 (ii) A Schedule ill or IV controlled substance may be filled only within six months of
221 issuance and may not be refilled more than six months after the date of its original issuance or
222 be refilled more than five times after the date of the prescription unless renewed by the
223 practitioner
224 (iii) All other controlled substances in Schedule V may be refilled as the prescribers
225 prescription directs but they may not be refilled one year after the date the prescription was
226 issued unless renewed by the practitioner
227 (iv) Any prescription for a Schedule IT substance may not be dispensed if it is not
228 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days
229 after the date the prescription was issued or 30 days after the dispensing date if that date is
230 specified separately from the date of issue
231 (v) A practitioner may issue more than one prescription at the same time for the same
232 Schedule IT controlled substance but only under the following conditions
233 (A) no more than three prescriptions for the same Schedule IT controlled substance may
234 be issued at the same time
235 (B) no one prescription may exceed a 30-day supply
236 (C) a second or third prescription shall include the date of issuance and the date for
237 dispensing and
238 (D) unless the practitioner determines there is a valid medical reason to the contrary
239 the date for dispensing a second or third prescription may not be fewer than 30 days from the
240 dispensing date of the previous prescription
241 [(1i) Each prescription rot a controlled snbstance may eontain only one controlled
242 substance per pIescription frlim and may not contain any other legend dmg 01 prescription
243 item]
244 (g) An order for a controlled substance in Schedules IT through V for use by an
- 8 shy
LEGISLATIVE GENERAL COUNSEL it Approved for Filing CJ Dupont it
HB114
it 02-06-14855 AM it
1 MAIL-ORDER WHOLESALE DRUG AMENDMENTS 2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Stewart Barlow
5 Senate Sponsor ______
6
7 LONG TITLE
8 General Description
9 This bill amends the Pharmacy Practice Act
10 Highlighted Provisions
11 This bill
12 ~ amends the definition of a class C pharmacy subject to regulation under the
13 Pharmacy Practice Act
14 Money Appropriated in this Bill
15 None
16 Other Special Clauses
17 This bi II takes effect on July 1 2014
18 Utah Code Sections Affected
19 AMENDS
20 58-17b-102 as last amended by Laws of Utah 2013 Chapters 52 166 and 423
21
22 Be it enacted by the Legislature ofthe state ofUtah
23 Section 1 Section 58-17b-102 is amended to read
24 58-17b-102 Definitions
25 In addition to the definitions in Section 58-1-102 as used in this chapter
26
27
(1) Administering means
(a) the direct application of a prescription drug or device whether by injection
==bull =bull
1111111111111111111111111111111111111111
02-06-14855 AM HB114
59 (9) Centralized prescription processing means the processing by a pharmacy of a
60 request from another pharmacy to fill or refill a prescription drug order or to perform
61 processing functions such as dispensing drug utilization review claims adjudication refill
62 authorizations and therapeutic interventions
63 (10) Class A pharmacy means a pharmacy located in Utah that is authorized as a
64 retail pharmacy to compound or dispense a drug or dispense a device to the public under a
65 prescription order
66 (11) Class B pharmacy
67 (a) means a pharmacy located in Utah
68 (i) that is authorized to provide pharmaceutical care for patients in an institutional
69 setting and
70 (ii) whose primary purpose is to provide a physical environment for patients to obtain
71 health care services and
72 (b) (i) includes closed-door hospital clinic nuclear and branch pharmacies and
73 (ii) pharmaceutical administration and sterile product preparation facilities
74 (12) Class C pharmacy means a pharmacy [located ill Utah that is anthOl ized to
75 engage] that engages in the manufacture production wholesale or distribution of drugs or
76 devices in Utah
77 (13) Class D pharmacy means a nonresident pharmacy
78 (14) Class E pharmacy means all other pharmacies
79 (15) Closed-door pharmacy means a pharmacy that provides pharmaceutical care to a
80 defined and exclusive group of patients who have access to the services of the pharmacy
81 because they are treated by or have an affiliation with a specific entity including a health
82 maintenance organization or an infusion company but not including a hospital pharmacy a
83 retailer of goods to the general public or the office of a practitioner
84 (16) Collaborative pharmacy practice means a practice of pharmacy whereby one or
85 more pharmacists have jointly agreed on a voluntary basis to work in conjunction with one or
86 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical
87 care functions authorized by the practitioner or practitioners under certain specified conditions
88 or limitations
89 (17) Collaborative pharmacy practice agreement means a written and signed
- 3 shy
02-06-14855 AM HB114
369 and
370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in
371 collaboration with the board
372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501
373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and
374 may be further defined by rule
375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that
376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration
377 for animals
378 Section 2 Effective date
379 This bill takes effect on July I 2014
Legislative Review Note as of 2-4-14 1243 PM
Office of Legislative Research and General Counsel
- 13 shy
LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t
t 02-05-14 122PM t
1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG
2 AMENDMENTS
3 2014 GENERAL SESSION
4 STATE OF UTAH
5 Chief Sponsor Stewart Barlow
6 Senate Sponsor
7
8 LONG TITLE
9 General Description
10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from
11 its licensing requirements under certain circumstances
12 Highlighted Provisions
13 This bill
14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy
15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an
16 employer sponsored clinic and complies with other requirements
17 repeals subject to sunset review the provisions of this bill relating to the exemption
18 described above and
19 ~ makes technical and conforming changes
20 Money Appropriated in this Bill
21 None
22 Other Special Clauses
23 None
24 Utah Code Sections Affected
25 AMENDS
26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~
27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull
1111111111111111111111111111111111111111
HBI06 02-05-14 122 PM
28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278
29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234
30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351
31 ENACTS
32 58-17b-3097 Utah Code Annotated 1953
33
34 Be it enacted by the Legislature ofthe state ofUtah
35 Section 1 Section 58-17b-301 is amended to read
36 58-17b-301 License required -- License classifications for individuals
37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the
38 practice of a pharmacy technician except as specifically provided in Section 58-1-307
39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097
40 (2) The division shall issue to an individual who qualifies under this chapter a license
41 in the classification of
42 (a) pharmacist
43 (b) pharmacy intern or
44 (c) pharmacy technician
45 Section 2 Section 58-17b-302 is amended to read
46 58-17b-302 License required -- License classifications for pharmacy facilities
47 (l) A license is required to act as a pharmacy except as specifically exempted from
48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or
49
50 (2) The division shall issue a pharmacy license to a facility that qualifies under this
51 chapter in the classification of a
52 (a) class A pharmacy
53 (b) class B pharmacy
54 (c) class C pharmacy
55 (d) class D pharmacy or
56 (e) class E pharmacy
57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist
58 at the same address a separate license shall be required for each pharmacy
-2shy
02-05-14 122 PM HBI06
59 (4) The division may further define or supplement the classifications of pharmacies
60 The division may impose restrictions upon classifications to protect the public health safety
61 and welfare
62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by
63 rule
64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy
65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities
66 of the pharmacy regardless of the form of the business organization
67 Section 3 Section 58-17b-309 is amended to read
68 58-17b-309 Exemptions from licensure
69 (l) [For ptnp05C5 of] As used in this section
70 (a) Cosmetic drug
71 (i) means a prescription drug that is
72 (A) for the purpose of promoting attractiveness or altering the appearance of an
73 individual and
74 (8) listed as a cosmetic drug subject to the exemption under this section by the division
75 by administrative rule or has been expressly approved for online dispensing whether or not it is
76 dispensed online or through a physicians office and
77 (ii) does not include a prescription drug that is
78 (A) a controlled substance
79 (8) compounded by the physician or
80 (C) prescribed or used for the patient for the purpose of diagnosing curing or
81 preventing a disease
82 (b) Injectable weight loss drug
83 (i) means an injectable prescription drug
84 (A) prescribed to promote weight loss and
85 (8) listed as an injectable prescription drug subject to exemption under this section by
86 the division by administrative rule and
87 (ii) does not include a prescription drug that is a controlled substance
88 (c) Prescribing practitioner means an individual licensed under
89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with
- 3 shy
HB106 02-05-14 122 PM
90 prescriptive practice
91 (ii) Chapter 67 Utah Medical Practice Act
92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or
93 (iv) Chapter 70a Physician Assistant Act
94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l
95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the
96 acts or practices described in this section without being licensed under this chapter
97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the
98 individual notifies the division in writing of the individuals intent to dispense a drug under this
99 [snbsectioll] Subsection (2)
100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1
101 (c) an individual engaging in the practice of pharmacy technician under the direct
102 personal supervision of a pharmacist while making satisfactory progress in an approved
103 program as defined in division rule
104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an
105 injectable weight loss drug to the prescribing practitioners patient in accordance with
106 Subsection (4) or
107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists
108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic
109 drug to the optometrists patient in accordance with Subsection (4)
110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under
111 Subsection (2)( c) must take all examinations as required by division rule following completion
112 of an approved curriculum of education within the required time frame This exemption
113 expires immediately upon notification of a failing score of an examination and the individual
114 may not continue working as a pharmacy technician even under direct supervision
115 (4) A prescribing practitioner or optometrist is exempt from licensing under the
116 provisions of this part if the prescribing practitioner or optometrist
117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the
118 authority to dispense under Subsection (4)(b) and
119 (ii) informs the patient
120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing
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HB106 02-05-14 122 PM
152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the
153 prescribing practitioners or optometrists office and determine if the provisions of this section
154 are being met by the prescribing practitioner or optometrist
155 (d) If a prescribing practitioner or optometrist violates a provision of this section the
156 prescribing practitioner or optometrist may be subject to discipline under
157 (i) this chapter and
158 (ii) (A) Chapter 16a Utah Optometry Practice Act
159 (B) Chapter 31 b Nurse Practice Act
160 (C) Chapter 67 Utah Medical Practice Act
161 (D) Chapter 68 Utah Osteopathic Medical Practice Act
162 (E) Chapter 70a Physician Assistant Act or
163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act
164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the
165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah
166 Optometry Practice Act
167 Section 4 Section 58-17b-3095 is amended to read
168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy
169 Division study of dispensing practitioners
170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen
171 (a) means a prescription drug used to treat cancer manage its symptoms or provide
172 continuity of care for a cancer patient
173 (b) includes
174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal
175 methods and
176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize
177 physical and psychological symptoms or pain or to improve patient tolerance of cancer
178 treatments or prepare a patient for a subsequent course of therapy and
179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug
180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections
181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt
182 from licensure under this chapter
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HB106 02-05-14 122 PM
214 (ii) is acting under the direction of a prescribing practitioner who is immediately
215 available on site for any necessary consultation and who has complied with Subsection
216 (2)(b)(i)
217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the
218 outpatient clinic setting and
219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)
220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to
221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section
222 (b) The evaluation under this Subsection (3) shall include
223 (i) practitioner compliance with the requirements of this section and Section
224 58-l7b-309
225 (ii) current research on dispensing and patient safety
226 (iii) survey of other state dispensing laws and
227 (iv) recommendations for future action concerning practitioner dispensing
228 (c) The division shall report to the Legislatures Health and Human Services Interim
229 Committee by November 302012 and by November 302013 with the results and
230 recommendations from the evaluation required by this Subsection (3)
231 (4) This section sunsets in accordance with Section 631-1-258
232 Section 5 Section 58-17b-3097 is enacted to read
233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an
234 employer sponsored clinic
235 (1) As used in this section
236 (a) Employer sponsored clinic means an entity that offers health care only to the
237 employees of an exclusive group of employers and the employees dependents
238 (b) Health care is as defined in Section 31 A-J-301
239 (c) Prepackaged drug means a prescription drug that
240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and
241 (ii) is packaged in a fixed quantity per package by
242 (A) the drug manufacturer
243 (B) a pharmaceutical wholesaler or distributor or
244 (C) a pharmacy licensed under this title
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02-05-14 122 PM HB106
245 Cd) Prescribing practitioner is as defined in Section 58-17b-309
246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309
247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing
248 requirements of this chapter if the prescribing practitioner
249 Ca) treats an employee of one of an exclusive group of employers at an employer
250 sponsored clinic
251 Cb) prescribes a prepackaged drug to the employee
252 Cc) dispenses the prepackaged drug at the employer sponsored clinic
253 (d) notifies the division
254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the
255 employer sponsored clinic and
256 (ii) of the drug the prescribing practitioner intends to dispense
257 Ce) determines that providing the prepackaged drug to the employee at the employer
258 sponsored clinic is in the employees best interest
259 (f) informs the employee
260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner
261 from a pharmacy that is unaffiliated with the prescribing practitioner
262 (ii) of the directions for appropriate use of the prepackaged drug
263 (iii) of potential side effects to the use of the prepackaged drug and
264 (iv) how to contact the prescribing practitioner if the employee has questions or
265 concerns regarding the drug
266 (g) offers the employee the opportunity to consult with a pharmacist if the employee
267 asks for patient counseling and
268 (h) follows the administrative rules for a prescribing practitioner at an employer
269 sponsored clinic established by the division under Subsection (4)
270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a
271 prepackaged drug under this section requires physician supervision in its scope ofpractice
272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the
273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter
274 68 Utah Osteopathic Medical Practice Act
275 (4) The division shall in consultation with the board of pharmacy and the Physicians
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HBI06 02-05-14 122 PM
276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title
277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping
278 patient counseling purchasing and distribution operating treatment quality of care and
279 storage requirements for a prescribing practitioner at an employer sponsored clinic
280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a
281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing
282 practitioner is in compliance with this section
283 (6) If a prescribing practitioner violates a provision of this section the prescribing
284 practitioner may be subject to discipline under
285 (a) this chapter and
286 (b) any other chapter that governs the terms of the prescribing practitioners license
287 (7) The division shall evaluate the exemption created by this section and report to the
288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1
289 2018 on the results of the evaluation and the divisions recommendations regarding the
290 exemption
291 Section 6 Section 631-1-258 is amended to read
292 631-1-258 Repeal dates Title 58
293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is
294 repealed July 12016
295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015
296 (3) Section 58-17b-3095 is repealed July 1 2015
297 (4) Section 58-17b-3097 is repealed on July 12018
298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1
299 2018
300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1
301 2023
302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing
303 Act is repealed July 1 2019
304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1
305 2015
306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is
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02-05-14 1 22 PM HB106
307 repealed July 12023
308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1
309 2014
310 [ttej] ill) Section 58-69-3025 is repealed on July 12015
311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017
Legislative Review Note as of 2-3-14 418 PM
Office of Legislative Research and General Counsel
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LEGISLA TIVE GENERAL COUNSEL SB138 ct Approved for Filing Sc Allred ct
ct 02-04-14 1220 PM ct
1 CONTROLLED SUBSTANCES ACT AMENDMENTS
2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Evan J Vickers
5 House Sponsor Stewart Barlow
6
7 LONG TITLE
8 General Description
9 This bill modifies the Utah Controlled Substances Act regarding prescriptions for
10 controlled substances
11 Highlighted Provisions
12 This bill
13 ~ provides that more than one controlled substance may be included in a prescription
14 Money Appropriated in this Bill
15 None
16 Other Special Clauses
17 None
18 Utah Code Sections Affected
19 AMENDS
20 58-37-6 as last amended by Laws of Utah 2012 Chapter 272
21
22 Be it enacted by the Legislature of the state ofUtah
23 Section 1 Section 58-37-6 is amended to read
24 58-37-6 License to manufacture produce distribute dispense administer or
25 conduct research -- Issuance by division -- Denial suspension or revocation -- Records
26
27
required -- Prescriptions
(1) (a) The division may adopt rules relating to the licensing and control of the bull
1111111111111111111111111111111111111111
SB138 02-04-14 1220 PM
214 (ii) the prescribed controlled substance is to be used in research
215 (f) Except when administered directly to an ultimate user by a licensed practitioner
216 controlled substances are subject to the following restrictions
217 (i) (A) A prescription for a Schedule IT substance may not be refilled
218 (B) A Schedule II controlled substance may not be filled in a quantity to exceed a
219 one-months supply as directed on the daily dosage rate of the prescriptions
220 (ii) A Schedule ill or IV controlled substance may be filled only within six months of
221 issuance and may not be refilled more than six months after the date of its original issuance or
222 be refilled more than five times after the date of the prescription unless renewed by the
223 practitioner
224 (iii) All other controlled substances in Schedule V may be refilled as the prescribers
225 prescription directs but they may not be refilled one year after the date the prescription was
226 issued unless renewed by the practitioner
227 (iv) Any prescription for a Schedule IT substance may not be dispensed if it is not
228 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days
229 after the date the prescription was issued or 30 days after the dispensing date if that date is
230 specified separately from the date of issue
231 (v) A practitioner may issue more than one prescription at the same time for the same
232 Schedule IT controlled substance but only under the following conditions
233 (A) no more than three prescriptions for the same Schedule IT controlled substance may
234 be issued at the same time
235 (B) no one prescription may exceed a 30-day supply
236 (C) a second or third prescription shall include the date of issuance and the date for
237 dispensing and
238 (D) unless the practitioner determines there is a valid medical reason to the contrary
239 the date for dispensing a second or third prescription may not be fewer than 30 days from the
240 dispensing date of the previous prescription
241 [(1i) Each prescription rot a controlled snbstance may eontain only one controlled
242 substance per pIescription frlim and may not contain any other legend dmg 01 prescription
243 item]
244 (g) An order for a controlled substance in Schedules IT through V for use by an
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LEGISLATIVE GENERAL COUNSEL it Approved for Filing CJ Dupont it
HB114
it 02-06-14855 AM it
1 MAIL-ORDER WHOLESALE DRUG AMENDMENTS 2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Stewart Barlow
5 Senate Sponsor ______
6
7 LONG TITLE
8 General Description
9 This bill amends the Pharmacy Practice Act
10 Highlighted Provisions
11 This bill
12 ~ amends the definition of a class C pharmacy subject to regulation under the
13 Pharmacy Practice Act
14 Money Appropriated in this Bill
15 None
16 Other Special Clauses
17 This bi II takes effect on July 1 2014
18 Utah Code Sections Affected
19 AMENDS
20 58-17b-102 as last amended by Laws of Utah 2013 Chapters 52 166 and 423
21
22 Be it enacted by the Legislature ofthe state ofUtah
23 Section 1 Section 58-17b-102 is amended to read
24 58-17b-102 Definitions
25 In addition to the definitions in Section 58-1-102 as used in this chapter
26
27
(1) Administering means
(a) the direct application of a prescription drug or device whether by injection
==bull =bull
1111111111111111111111111111111111111111
02-06-14855 AM HB114
59 (9) Centralized prescription processing means the processing by a pharmacy of a
60 request from another pharmacy to fill or refill a prescription drug order or to perform
61 processing functions such as dispensing drug utilization review claims adjudication refill
62 authorizations and therapeutic interventions
63 (10) Class A pharmacy means a pharmacy located in Utah that is authorized as a
64 retail pharmacy to compound or dispense a drug or dispense a device to the public under a
65 prescription order
66 (11) Class B pharmacy
67 (a) means a pharmacy located in Utah
68 (i) that is authorized to provide pharmaceutical care for patients in an institutional
69 setting and
70 (ii) whose primary purpose is to provide a physical environment for patients to obtain
71 health care services and
72 (b) (i) includes closed-door hospital clinic nuclear and branch pharmacies and
73 (ii) pharmaceutical administration and sterile product preparation facilities
74 (12) Class C pharmacy means a pharmacy [located ill Utah that is anthOl ized to
75 engage] that engages in the manufacture production wholesale or distribution of drugs or
76 devices in Utah
77 (13) Class D pharmacy means a nonresident pharmacy
78 (14) Class E pharmacy means all other pharmacies
79 (15) Closed-door pharmacy means a pharmacy that provides pharmaceutical care to a
80 defined and exclusive group of patients who have access to the services of the pharmacy
81 because they are treated by or have an affiliation with a specific entity including a health
82 maintenance organization or an infusion company but not including a hospital pharmacy a
83 retailer of goods to the general public or the office of a practitioner
84 (16) Collaborative pharmacy practice means a practice of pharmacy whereby one or
85 more pharmacists have jointly agreed on a voluntary basis to work in conjunction with one or
86 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical
87 care functions authorized by the practitioner or practitioners under certain specified conditions
88 or limitations
89 (17) Collaborative pharmacy practice agreement means a written and signed
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02-06-14855 AM HB114
369 and
370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in
371 collaboration with the board
372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501
373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and
374 may be further defined by rule
375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that
376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration
377 for animals
378 Section 2 Effective date
379 This bill takes effect on July I 2014
Legislative Review Note as of 2-4-14 1243 PM
Office of Legislative Research and General Counsel
- 13 shy
LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t
t 02-05-14 122PM t
1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG
2 AMENDMENTS
3 2014 GENERAL SESSION
4 STATE OF UTAH
5 Chief Sponsor Stewart Barlow
6 Senate Sponsor
7
8 LONG TITLE
9 General Description
10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from
11 its licensing requirements under certain circumstances
12 Highlighted Provisions
13 This bill
14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy
15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an
16 employer sponsored clinic and complies with other requirements
17 repeals subject to sunset review the provisions of this bill relating to the exemption
18 described above and
19 ~ makes technical and conforming changes
20 Money Appropriated in this Bill
21 None
22 Other Special Clauses
23 None
24 Utah Code Sections Affected
25 AMENDS
26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~
27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull
1111111111111111111111111111111111111111
HBI06 02-05-14 122 PM
28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278
29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234
30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351
31 ENACTS
32 58-17b-3097 Utah Code Annotated 1953
33
34 Be it enacted by the Legislature ofthe state ofUtah
35 Section 1 Section 58-17b-301 is amended to read
36 58-17b-301 License required -- License classifications for individuals
37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the
38 practice of a pharmacy technician except as specifically provided in Section 58-1-307
39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097
40 (2) The division shall issue to an individual who qualifies under this chapter a license
41 in the classification of
42 (a) pharmacist
43 (b) pharmacy intern or
44 (c) pharmacy technician
45 Section 2 Section 58-17b-302 is amended to read
46 58-17b-302 License required -- License classifications for pharmacy facilities
47 (l) A license is required to act as a pharmacy except as specifically exempted from
48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or
49
50 (2) The division shall issue a pharmacy license to a facility that qualifies under this
51 chapter in the classification of a
52 (a) class A pharmacy
53 (b) class B pharmacy
54 (c) class C pharmacy
55 (d) class D pharmacy or
56 (e) class E pharmacy
57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist
58 at the same address a separate license shall be required for each pharmacy
-2shy
02-05-14 122 PM HBI06
59 (4) The division may further define or supplement the classifications of pharmacies
60 The division may impose restrictions upon classifications to protect the public health safety
61 and welfare
62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by
63 rule
64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy
65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities
66 of the pharmacy regardless of the form of the business organization
67 Section 3 Section 58-17b-309 is amended to read
68 58-17b-309 Exemptions from licensure
69 (l) [For ptnp05C5 of] As used in this section
70 (a) Cosmetic drug
71 (i) means a prescription drug that is
72 (A) for the purpose of promoting attractiveness or altering the appearance of an
73 individual and
74 (8) listed as a cosmetic drug subject to the exemption under this section by the division
75 by administrative rule or has been expressly approved for online dispensing whether or not it is
76 dispensed online or through a physicians office and
77 (ii) does not include a prescription drug that is
78 (A) a controlled substance
79 (8) compounded by the physician or
80 (C) prescribed or used for the patient for the purpose of diagnosing curing or
81 preventing a disease
82 (b) Injectable weight loss drug
83 (i) means an injectable prescription drug
84 (A) prescribed to promote weight loss and
85 (8) listed as an injectable prescription drug subject to exemption under this section by
86 the division by administrative rule and
87 (ii) does not include a prescription drug that is a controlled substance
88 (c) Prescribing practitioner means an individual licensed under
89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with
- 3 shy
HB106 02-05-14 122 PM
90 prescriptive practice
91 (ii) Chapter 67 Utah Medical Practice Act
92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or
93 (iv) Chapter 70a Physician Assistant Act
94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l
95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the
96 acts or practices described in this section without being licensed under this chapter
97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the
98 individual notifies the division in writing of the individuals intent to dispense a drug under this
99 [snbsectioll] Subsection (2)
100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1
101 (c) an individual engaging in the practice of pharmacy technician under the direct
102 personal supervision of a pharmacist while making satisfactory progress in an approved
103 program as defined in division rule
104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an
105 injectable weight loss drug to the prescribing practitioners patient in accordance with
106 Subsection (4) or
107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists
108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic
109 drug to the optometrists patient in accordance with Subsection (4)
110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under
111 Subsection (2)( c) must take all examinations as required by division rule following completion
112 of an approved curriculum of education within the required time frame This exemption
113 expires immediately upon notification of a failing score of an examination and the individual
114 may not continue working as a pharmacy technician even under direct supervision
115 (4) A prescribing practitioner or optometrist is exempt from licensing under the
116 provisions of this part if the prescribing practitioner or optometrist
117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the
118 authority to dispense under Subsection (4)(b) and
119 (ii) informs the patient
120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing
-4shy
HB106 02-05-14 122 PM
152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the
153 prescribing practitioners or optometrists office and determine if the provisions of this section
154 are being met by the prescribing practitioner or optometrist
155 (d) If a prescribing practitioner or optometrist violates a provision of this section the
156 prescribing practitioner or optometrist may be subject to discipline under
157 (i) this chapter and
158 (ii) (A) Chapter 16a Utah Optometry Practice Act
159 (B) Chapter 31 b Nurse Practice Act
160 (C) Chapter 67 Utah Medical Practice Act
161 (D) Chapter 68 Utah Osteopathic Medical Practice Act
162 (E) Chapter 70a Physician Assistant Act or
163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act
164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the
165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah
166 Optometry Practice Act
167 Section 4 Section 58-17b-3095 is amended to read
168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy
169 Division study of dispensing practitioners
170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen
171 (a) means a prescription drug used to treat cancer manage its symptoms or provide
172 continuity of care for a cancer patient
173 (b) includes
174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal
175 methods and
176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize
177 physical and psychological symptoms or pain or to improve patient tolerance of cancer
178 treatments or prepare a patient for a subsequent course of therapy and
179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug
180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections
181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt
182 from licensure under this chapter
- 6shy
HB106 02-05-14 122 PM
214 (ii) is acting under the direction of a prescribing practitioner who is immediately
215 available on site for any necessary consultation and who has complied with Subsection
216 (2)(b)(i)
217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the
218 outpatient clinic setting and
219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)
220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to
221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section
222 (b) The evaluation under this Subsection (3) shall include
223 (i) practitioner compliance with the requirements of this section and Section
224 58-l7b-309
225 (ii) current research on dispensing and patient safety
226 (iii) survey of other state dispensing laws and
227 (iv) recommendations for future action concerning practitioner dispensing
228 (c) The division shall report to the Legislatures Health and Human Services Interim
229 Committee by November 302012 and by November 302013 with the results and
230 recommendations from the evaluation required by this Subsection (3)
231 (4) This section sunsets in accordance with Section 631-1-258
232 Section 5 Section 58-17b-3097 is enacted to read
233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an
234 employer sponsored clinic
235 (1) As used in this section
236 (a) Employer sponsored clinic means an entity that offers health care only to the
237 employees of an exclusive group of employers and the employees dependents
238 (b) Health care is as defined in Section 31 A-J-301
239 (c) Prepackaged drug means a prescription drug that
240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and
241 (ii) is packaged in a fixed quantity per package by
242 (A) the drug manufacturer
243 (B) a pharmaceutical wholesaler or distributor or
244 (C) a pharmacy licensed under this title
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02-05-14 122 PM HB106
245 Cd) Prescribing practitioner is as defined in Section 58-17b-309
246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309
247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing
248 requirements of this chapter if the prescribing practitioner
249 Ca) treats an employee of one of an exclusive group of employers at an employer
250 sponsored clinic
251 Cb) prescribes a prepackaged drug to the employee
252 Cc) dispenses the prepackaged drug at the employer sponsored clinic
253 (d) notifies the division
254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the
255 employer sponsored clinic and
256 (ii) of the drug the prescribing practitioner intends to dispense
257 Ce) determines that providing the prepackaged drug to the employee at the employer
258 sponsored clinic is in the employees best interest
259 (f) informs the employee
260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner
261 from a pharmacy that is unaffiliated with the prescribing practitioner
262 (ii) of the directions for appropriate use of the prepackaged drug
263 (iii) of potential side effects to the use of the prepackaged drug and
264 (iv) how to contact the prescribing practitioner if the employee has questions or
265 concerns regarding the drug
266 (g) offers the employee the opportunity to consult with a pharmacist if the employee
267 asks for patient counseling and
268 (h) follows the administrative rules for a prescribing practitioner at an employer
269 sponsored clinic established by the division under Subsection (4)
270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a
271 prepackaged drug under this section requires physician supervision in its scope ofpractice
272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the
273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter
274 68 Utah Osteopathic Medical Practice Act
275 (4) The division shall in consultation with the board of pharmacy and the Physicians
- 9 shy
HBI06 02-05-14 122 PM
276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title
277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping
278 patient counseling purchasing and distribution operating treatment quality of care and
279 storage requirements for a prescribing practitioner at an employer sponsored clinic
280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a
281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing
282 practitioner is in compliance with this section
283 (6) If a prescribing practitioner violates a provision of this section the prescribing
284 practitioner may be subject to discipline under
285 (a) this chapter and
286 (b) any other chapter that governs the terms of the prescribing practitioners license
287 (7) The division shall evaluate the exemption created by this section and report to the
288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1
289 2018 on the results of the evaluation and the divisions recommendations regarding the
290 exemption
291 Section 6 Section 631-1-258 is amended to read
292 631-1-258 Repeal dates Title 58
293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is
294 repealed July 12016
295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015
296 (3) Section 58-17b-3095 is repealed July 1 2015
297 (4) Section 58-17b-3097 is repealed on July 12018
298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1
299 2018
300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1
301 2023
302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing
303 Act is repealed July 1 2019
304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1
305 2015
306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is
- 10shy
02-05-14 1 22 PM HB106
307 repealed July 12023
308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1
309 2014
310 [ttej] ill) Section 58-69-3025 is repealed on July 12015
311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017
Legislative Review Note as of 2-3-14 418 PM
Office of Legislative Research and General Counsel
- 11 shy
SB138 02-04-14 1220 PM
214 (ii) the prescribed controlled substance is to be used in research
215 (f) Except when administered directly to an ultimate user by a licensed practitioner
216 controlled substances are subject to the following restrictions
217 (i) (A) A prescription for a Schedule IT substance may not be refilled
218 (B) A Schedule II controlled substance may not be filled in a quantity to exceed a
219 one-months supply as directed on the daily dosage rate of the prescriptions
220 (ii) A Schedule ill or IV controlled substance may be filled only within six months of
221 issuance and may not be refilled more than six months after the date of its original issuance or
222 be refilled more than five times after the date of the prescription unless renewed by the
223 practitioner
224 (iii) All other controlled substances in Schedule V may be refilled as the prescribers
225 prescription directs but they may not be refilled one year after the date the prescription was
226 issued unless renewed by the practitioner
227 (iv) Any prescription for a Schedule IT substance may not be dispensed if it is not
228 presented to a pharmacist for dispensing by a pharmacist or a pharmacy intern within 30 days
229 after the date the prescription was issued or 30 days after the dispensing date if that date is
230 specified separately from the date of issue
231 (v) A practitioner may issue more than one prescription at the same time for the same
232 Schedule IT controlled substance but only under the following conditions
233 (A) no more than three prescriptions for the same Schedule IT controlled substance may
234 be issued at the same time
235 (B) no one prescription may exceed a 30-day supply
236 (C) a second or third prescription shall include the date of issuance and the date for
237 dispensing and
238 (D) unless the practitioner determines there is a valid medical reason to the contrary
239 the date for dispensing a second or third prescription may not be fewer than 30 days from the
240 dispensing date of the previous prescription
241 [(1i) Each prescription rot a controlled snbstance may eontain only one controlled
242 substance per pIescription frlim and may not contain any other legend dmg 01 prescription
243 item]
244 (g) An order for a controlled substance in Schedules IT through V for use by an
- 8 shy
LEGISLATIVE GENERAL COUNSEL it Approved for Filing CJ Dupont it
HB114
it 02-06-14855 AM it
1 MAIL-ORDER WHOLESALE DRUG AMENDMENTS 2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Stewart Barlow
5 Senate Sponsor ______
6
7 LONG TITLE
8 General Description
9 This bill amends the Pharmacy Practice Act
10 Highlighted Provisions
11 This bill
12 ~ amends the definition of a class C pharmacy subject to regulation under the
13 Pharmacy Practice Act
14 Money Appropriated in this Bill
15 None
16 Other Special Clauses
17 This bi II takes effect on July 1 2014
18 Utah Code Sections Affected
19 AMENDS
20 58-17b-102 as last amended by Laws of Utah 2013 Chapters 52 166 and 423
21
22 Be it enacted by the Legislature ofthe state ofUtah
23 Section 1 Section 58-17b-102 is amended to read
24 58-17b-102 Definitions
25 In addition to the definitions in Section 58-1-102 as used in this chapter
26
27
(1) Administering means
(a) the direct application of a prescription drug or device whether by injection
==bull =bull
1111111111111111111111111111111111111111
02-06-14855 AM HB114
59 (9) Centralized prescription processing means the processing by a pharmacy of a
60 request from another pharmacy to fill or refill a prescription drug order or to perform
61 processing functions such as dispensing drug utilization review claims adjudication refill
62 authorizations and therapeutic interventions
63 (10) Class A pharmacy means a pharmacy located in Utah that is authorized as a
64 retail pharmacy to compound or dispense a drug or dispense a device to the public under a
65 prescription order
66 (11) Class B pharmacy
67 (a) means a pharmacy located in Utah
68 (i) that is authorized to provide pharmaceutical care for patients in an institutional
69 setting and
70 (ii) whose primary purpose is to provide a physical environment for patients to obtain
71 health care services and
72 (b) (i) includes closed-door hospital clinic nuclear and branch pharmacies and
73 (ii) pharmaceutical administration and sterile product preparation facilities
74 (12) Class C pharmacy means a pharmacy [located ill Utah that is anthOl ized to
75 engage] that engages in the manufacture production wholesale or distribution of drugs or
76 devices in Utah
77 (13) Class D pharmacy means a nonresident pharmacy
78 (14) Class E pharmacy means all other pharmacies
79 (15) Closed-door pharmacy means a pharmacy that provides pharmaceutical care to a
80 defined and exclusive group of patients who have access to the services of the pharmacy
81 because they are treated by or have an affiliation with a specific entity including a health
82 maintenance organization or an infusion company but not including a hospital pharmacy a
83 retailer of goods to the general public or the office of a practitioner
84 (16) Collaborative pharmacy practice means a practice of pharmacy whereby one or
85 more pharmacists have jointly agreed on a voluntary basis to work in conjunction with one or
86 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical
87 care functions authorized by the practitioner or practitioners under certain specified conditions
88 or limitations
89 (17) Collaborative pharmacy practice agreement means a written and signed
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02-06-14855 AM HB114
369 and
370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in
371 collaboration with the board
372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501
373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and
374 may be further defined by rule
375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that
376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration
377 for animals
378 Section 2 Effective date
379 This bill takes effect on July I 2014
Legislative Review Note as of 2-4-14 1243 PM
Office of Legislative Research and General Counsel
- 13 shy
LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t
t 02-05-14 122PM t
1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG
2 AMENDMENTS
3 2014 GENERAL SESSION
4 STATE OF UTAH
5 Chief Sponsor Stewart Barlow
6 Senate Sponsor
7
8 LONG TITLE
9 General Description
10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from
11 its licensing requirements under certain circumstances
12 Highlighted Provisions
13 This bill
14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy
15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an
16 employer sponsored clinic and complies with other requirements
17 repeals subject to sunset review the provisions of this bill relating to the exemption
18 described above and
19 ~ makes technical and conforming changes
20 Money Appropriated in this Bill
21 None
22 Other Special Clauses
23 None
24 Utah Code Sections Affected
25 AMENDS
26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~
27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull
1111111111111111111111111111111111111111
HBI06 02-05-14 122 PM
28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278
29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234
30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351
31 ENACTS
32 58-17b-3097 Utah Code Annotated 1953
33
34 Be it enacted by the Legislature ofthe state ofUtah
35 Section 1 Section 58-17b-301 is amended to read
36 58-17b-301 License required -- License classifications for individuals
37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the
38 practice of a pharmacy technician except as specifically provided in Section 58-1-307
39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097
40 (2) The division shall issue to an individual who qualifies under this chapter a license
41 in the classification of
42 (a) pharmacist
43 (b) pharmacy intern or
44 (c) pharmacy technician
45 Section 2 Section 58-17b-302 is amended to read
46 58-17b-302 License required -- License classifications for pharmacy facilities
47 (l) A license is required to act as a pharmacy except as specifically exempted from
48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or
49
50 (2) The division shall issue a pharmacy license to a facility that qualifies under this
51 chapter in the classification of a
52 (a) class A pharmacy
53 (b) class B pharmacy
54 (c) class C pharmacy
55 (d) class D pharmacy or
56 (e) class E pharmacy
57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist
58 at the same address a separate license shall be required for each pharmacy
-2shy
02-05-14 122 PM HBI06
59 (4) The division may further define or supplement the classifications of pharmacies
60 The division may impose restrictions upon classifications to protect the public health safety
61 and welfare
62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by
63 rule
64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy
65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities
66 of the pharmacy regardless of the form of the business organization
67 Section 3 Section 58-17b-309 is amended to read
68 58-17b-309 Exemptions from licensure
69 (l) [For ptnp05C5 of] As used in this section
70 (a) Cosmetic drug
71 (i) means a prescription drug that is
72 (A) for the purpose of promoting attractiveness or altering the appearance of an
73 individual and
74 (8) listed as a cosmetic drug subject to the exemption under this section by the division
75 by administrative rule or has been expressly approved for online dispensing whether or not it is
76 dispensed online or through a physicians office and
77 (ii) does not include a prescription drug that is
78 (A) a controlled substance
79 (8) compounded by the physician or
80 (C) prescribed or used for the patient for the purpose of diagnosing curing or
81 preventing a disease
82 (b) Injectable weight loss drug
83 (i) means an injectable prescription drug
84 (A) prescribed to promote weight loss and
85 (8) listed as an injectable prescription drug subject to exemption under this section by
86 the division by administrative rule and
87 (ii) does not include a prescription drug that is a controlled substance
88 (c) Prescribing practitioner means an individual licensed under
89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with
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HB106 02-05-14 122 PM
90 prescriptive practice
91 (ii) Chapter 67 Utah Medical Practice Act
92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or
93 (iv) Chapter 70a Physician Assistant Act
94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l
95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the
96 acts or practices described in this section without being licensed under this chapter
97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the
98 individual notifies the division in writing of the individuals intent to dispense a drug under this
99 [snbsectioll] Subsection (2)
100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1
101 (c) an individual engaging in the practice of pharmacy technician under the direct
102 personal supervision of a pharmacist while making satisfactory progress in an approved
103 program as defined in division rule
104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an
105 injectable weight loss drug to the prescribing practitioners patient in accordance with
106 Subsection (4) or
107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists
108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic
109 drug to the optometrists patient in accordance with Subsection (4)
110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under
111 Subsection (2)( c) must take all examinations as required by division rule following completion
112 of an approved curriculum of education within the required time frame This exemption
113 expires immediately upon notification of a failing score of an examination and the individual
114 may not continue working as a pharmacy technician even under direct supervision
115 (4) A prescribing practitioner or optometrist is exempt from licensing under the
116 provisions of this part if the prescribing practitioner or optometrist
117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the
118 authority to dispense under Subsection (4)(b) and
119 (ii) informs the patient
120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing
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HB106 02-05-14 122 PM
152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the
153 prescribing practitioners or optometrists office and determine if the provisions of this section
154 are being met by the prescribing practitioner or optometrist
155 (d) If a prescribing practitioner or optometrist violates a provision of this section the
156 prescribing practitioner or optometrist may be subject to discipline under
157 (i) this chapter and
158 (ii) (A) Chapter 16a Utah Optometry Practice Act
159 (B) Chapter 31 b Nurse Practice Act
160 (C) Chapter 67 Utah Medical Practice Act
161 (D) Chapter 68 Utah Osteopathic Medical Practice Act
162 (E) Chapter 70a Physician Assistant Act or
163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act
164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the
165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah
166 Optometry Practice Act
167 Section 4 Section 58-17b-3095 is amended to read
168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy
169 Division study of dispensing practitioners
170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen
171 (a) means a prescription drug used to treat cancer manage its symptoms or provide
172 continuity of care for a cancer patient
173 (b) includes
174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal
175 methods and
176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize
177 physical and psychological symptoms or pain or to improve patient tolerance of cancer
178 treatments or prepare a patient for a subsequent course of therapy and
179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug
180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections
181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt
182 from licensure under this chapter
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HB106 02-05-14 122 PM
214 (ii) is acting under the direction of a prescribing practitioner who is immediately
215 available on site for any necessary consultation and who has complied with Subsection
216 (2)(b)(i)
217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the
218 outpatient clinic setting and
219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)
220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to
221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section
222 (b) The evaluation under this Subsection (3) shall include
223 (i) practitioner compliance with the requirements of this section and Section
224 58-l7b-309
225 (ii) current research on dispensing and patient safety
226 (iii) survey of other state dispensing laws and
227 (iv) recommendations for future action concerning practitioner dispensing
228 (c) The division shall report to the Legislatures Health and Human Services Interim
229 Committee by November 302012 and by November 302013 with the results and
230 recommendations from the evaluation required by this Subsection (3)
231 (4) This section sunsets in accordance with Section 631-1-258
232 Section 5 Section 58-17b-3097 is enacted to read
233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an
234 employer sponsored clinic
235 (1) As used in this section
236 (a) Employer sponsored clinic means an entity that offers health care only to the
237 employees of an exclusive group of employers and the employees dependents
238 (b) Health care is as defined in Section 31 A-J-301
239 (c) Prepackaged drug means a prescription drug that
240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and
241 (ii) is packaged in a fixed quantity per package by
242 (A) the drug manufacturer
243 (B) a pharmaceutical wholesaler or distributor or
244 (C) a pharmacy licensed under this title
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~ -- -------------------
02-05-14 122 PM HB106
245 Cd) Prescribing practitioner is as defined in Section 58-17b-309
246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309
247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing
248 requirements of this chapter if the prescribing practitioner
249 Ca) treats an employee of one of an exclusive group of employers at an employer
250 sponsored clinic
251 Cb) prescribes a prepackaged drug to the employee
252 Cc) dispenses the prepackaged drug at the employer sponsored clinic
253 (d) notifies the division
254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the
255 employer sponsored clinic and
256 (ii) of the drug the prescribing practitioner intends to dispense
257 Ce) determines that providing the prepackaged drug to the employee at the employer
258 sponsored clinic is in the employees best interest
259 (f) informs the employee
260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner
261 from a pharmacy that is unaffiliated with the prescribing practitioner
262 (ii) of the directions for appropriate use of the prepackaged drug
263 (iii) of potential side effects to the use of the prepackaged drug and
264 (iv) how to contact the prescribing practitioner if the employee has questions or
265 concerns regarding the drug
266 (g) offers the employee the opportunity to consult with a pharmacist if the employee
267 asks for patient counseling and
268 (h) follows the administrative rules for a prescribing practitioner at an employer
269 sponsored clinic established by the division under Subsection (4)
270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a
271 prepackaged drug under this section requires physician supervision in its scope ofpractice
272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the
273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter
274 68 Utah Osteopathic Medical Practice Act
275 (4) The division shall in consultation with the board of pharmacy and the Physicians
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HBI06 02-05-14 122 PM
276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title
277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping
278 patient counseling purchasing and distribution operating treatment quality of care and
279 storage requirements for a prescribing practitioner at an employer sponsored clinic
280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a
281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing
282 practitioner is in compliance with this section
283 (6) If a prescribing practitioner violates a provision of this section the prescribing
284 practitioner may be subject to discipline under
285 (a) this chapter and
286 (b) any other chapter that governs the terms of the prescribing practitioners license
287 (7) The division shall evaluate the exemption created by this section and report to the
288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1
289 2018 on the results of the evaluation and the divisions recommendations regarding the
290 exemption
291 Section 6 Section 631-1-258 is amended to read
292 631-1-258 Repeal dates Title 58
293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is
294 repealed July 12016
295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015
296 (3) Section 58-17b-3095 is repealed July 1 2015
297 (4) Section 58-17b-3097 is repealed on July 12018
298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1
299 2018
300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1
301 2023
302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing
303 Act is repealed July 1 2019
304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1
305 2015
306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is
- 10shy
02-05-14 1 22 PM HB106
307 repealed July 12023
308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1
309 2014
310 [ttej] ill) Section 58-69-3025 is repealed on July 12015
311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017
Legislative Review Note as of 2-3-14 418 PM
Office of Legislative Research and General Counsel
- 11 shy
LEGISLATIVE GENERAL COUNSEL it Approved for Filing CJ Dupont it
HB114
it 02-06-14855 AM it
1 MAIL-ORDER WHOLESALE DRUG AMENDMENTS 2 2014 GENERAL SESSION
3 STATE OF UTAH
4 Chief Sponsor Stewart Barlow
5 Senate Sponsor ______
6
7 LONG TITLE
8 General Description
9 This bill amends the Pharmacy Practice Act
10 Highlighted Provisions
11 This bill
12 ~ amends the definition of a class C pharmacy subject to regulation under the
13 Pharmacy Practice Act
14 Money Appropriated in this Bill
15 None
16 Other Special Clauses
17 This bi II takes effect on July 1 2014
18 Utah Code Sections Affected
19 AMENDS
20 58-17b-102 as last amended by Laws of Utah 2013 Chapters 52 166 and 423
21
22 Be it enacted by the Legislature ofthe state ofUtah
23 Section 1 Section 58-17b-102 is amended to read
24 58-17b-102 Definitions
25 In addition to the definitions in Section 58-1-102 as used in this chapter
26
27
(1) Administering means
(a) the direct application of a prescription drug or device whether by injection
==bull =bull
1111111111111111111111111111111111111111
02-06-14855 AM HB114
59 (9) Centralized prescription processing means the processing by a pharmacy of a
60 request from another pharmacy to fill or refill a prescription drug order or to perform
61 processing functions such as dispensing drug utilization review claims adjudication refill
62 authorizations and therapeutic interventions
63 (10) Class A pharmacy means a pharmacy located in Utah that is authorized as a
64 retail pharmacy to compound or dispense a drug or dispense a device to the public under a
65 prescription order
66 (11) Class B pharmacy
67 (a) means a pharmacy located in Utah
68 (i) that is authorized to provide pharmaceutical care for patients in an institutional
69 setting and
70 (ii) whose primary purpose is to provide a physical environment for patients to obtain
71 health care services and
72 (b) (i) includes closed-door hospital clinic nuclear and branch pharmacies and
73 (ii) pharmaceutical administration and sterile product preparation facilities
74 (12) Class C pharmacy means a pharmacy [located ill Utah that is anthOl ized to
75 engage] that engages in the manufacture production wholesale or distribution of drugs or
76 devices in Utah
77 (13) Class D pharmacy means a nonresident pharmacy
78 (14) Class E pharmacy means all other pharmacies
79 (15) Closed-door pharmacy means a pharmacy that provides pharmaceutical care to a
80 defined and exclusive group of patients who have access to the services of the pharmacy
81 because they are treated by or have an affiliation with a specific entity including a health
82 maintenance organization or an infusion company but not including a hospital pharmacy a
83 retailer of goods to the general public or the office of a practitioner
84 (16) Collaborative pharmacy practice means a practice of pharmacy whereby one or
85 more pharmacists have jointly agreed on a voluntary basis to work in conjunction with one or
86 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical
87 care functions authorized by the practitioner or practitioners under certain specified conditions
88 or limitations
89 (17) Collaborative pharmacy practice agreement means a written and signed
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02-06-14855 AM HB114
369 and
370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in
371 collaboration with the board
372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501
373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and
374 may be further defined by rule
375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that
376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration
377 for animals
378 Section 2 Effective date
379 This bill takes effect on July I 2014
Legislative Review Note as of 2-4-14 1243 PM
Office of Legislative Research and General Counsel
- 13 shy
LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t
t 02-05-14 122PM t
1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG
2 AMENDMENTS
3 2014 GENERAL SESSION
4 STATE OF UTAH
5 Chief Sponsor Stewart Barlow
6 Senate Sponsor
7
8 LONG TITLE
9 General Description
10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from
11 its licensing requirements under certain circumstances
12 Highlighted Provisions
13 This bill
14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy
15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an
16 employer sponsored clinic and complies with other requirements
17 repeals subject to sunset review the provisions of this bill relating to the exemption
18 described above and
19 ~ makes technical and conforming changes
20 Money Appropriated in this Bill
21 None
22 Other Special Clauses
23 None
24 Utah Code Sections Affected
25 AMENDS
26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~
27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull
1111111111111111111111111111111111111111
HBI06 02-05-14 122 PM
28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278
29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234
30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351
31 ENACTS
32 58-17b-3097 Utah Code Annotated 1953
33
34 Be it enacted by the Legislature ofthe state ofUtah
35 Section 1 Section 58-17b-301 is amended to read
36 58-17b-301 License required -- License classifications for individuals
37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the
38 practice of a pharmacy technician except as specifically provided in Section 58-1-307
39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097
40 (2) The division shall issue to an individual who qualifies under this chapter a license
41 in the classification of
42 (a) pharmacist
43 (b) pharmacy intern or
44 (c) pharmacy technician
45 Section 2 Section 58-17b-302 is amended to read
46 58-17b-302 License required -- License classifications for pharmacy facilities
47 (l) A license is required to act as a pharmacy except as specifically exempted from
48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or
49
50 (2) The division shall issue a pharmacy license to a facility that qualifies under this
51 chapter in the classification of a
52 (a) class A pharmacy
53 (b) class B pharmacy
54 (c) class C pharmacy
55 (d) class D pharmacy or
56 (e) class E pharmacy
57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist
58 at the same address a separate license shall be required for each pharmacy
-2shy
02-05-14 122 PM HBI06
59 (4) The division may further define or supplement the classifications of pharmacies
60 The division may impose restrictions upon classifications to protect the public health safety
61 and welfare
62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by
63 rule
64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy
65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities
66 of the pharmacy regardless of the form of the business organization
67 Section 3 Section 58-17b-309 is amended to read
68 58-17b-309 Exemptions from licensure
69 (l) [For ptnp05C5 of] As used in this section
70 (a) Cosmetic drug
71 (i) means a prescription drug that is
72 (A) for the purpose of promoting attractiveness or altering the appearance of an
73 individual and
74 (8) listed as a cosmetic drug subject to the exemption under this section by the division
75 by administrative rule or has been expressly approved for online dispensing whether or not it is
76 dispensed online or through a physicians office and
77 (ii) does not include a prescription drug that is
78 (A) a controlled substance
79 (8) compounded by the physician or
80 (C) prescribed or used for the patient for the purpose of diagnosing curing or
81 preventing a disease
82 (b) Injectable weight loss drug
83 (i) means an injectable prescription drug
84 (A) prescribed to promote weight loss and
85 (8) listed as an injectable prescription drug subject to exemption under this section by
86 the division by administrative rule and
87 (ii) does not include a prescription drug that is a controlled substance
88 (c) Prescribing practitioner means an individual licensed under
89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with
- 3 shy
HB106 02-05-14 122 PM
90 prescriptive practice
91 (ii) Chapter 67 Utah Medical Practice Act
92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or
93 (iv) Chapter 70a Physician Assistant Act
94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l
95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the
96 acts or practices described in this section without being licensed under this chapter
97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the
98 individual notifies the division in writing of the individuals intent to dispense a drug under this
99 [snbsectioll] Subsection (2)
100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1
101 (c) an individual engaging in the practice of pharmacy technician under the direct
102 personal supervision of a pharmacist while making satisfactory progress in an approved
103 program as defined in division rule
104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an
105 injectable weight loss drug to the prescribing practitioners patient in accordance with
106 Subsection (4) or
107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists
108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic
109 drug to the optometrists patient in accordance with Subsection (4)
110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under
111 Subsection (2)( c) must take all examinations as required by division rule following completion
112 of an approved curriculum of education within the required time frame This exemption
113 expires immediately upon notification of a failing score of an examination and the individual
114 may not continue working as a pharmacy technician even under direct supervision
115 (4) A prescribing practitioner or optometrist is exempt from licensing under the
116 provisions of this part if the prescribing practitioner or optometrist
117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the
118 authority to dispense under Subsection (4)(b) and
119 (ii) informs the patient
120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing
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HB106 02-05-14 122 PM
152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the
153 prescribing practitioners or optometrists office and determine if the provisions of this section
154 are being met by the prescribing practitioner or optometrist
155 (d) If a prescribing practitioner or optometrist violates a provision of this section the
156 prescribing practitioner or optometrist may be subject to discipline under
157 (i) this chapter and
158 (ii) (A) Chapter 16a Utah Optometry Practice Act
159 (B) Chapter 31 b Nurse Practice Act
160 (C) Chapter 67 Utah Medical Practice Act
161 (D) Chapter 68 Utah Osteopathic Medical Practice Act
162 (E) Chapter 70a Physician Assistant Act or
163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act
164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the
165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah
166 Optometry Practice Act
167 Section 4 Section 58-17b-3095 is amended to read
168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy
169 Division study of dispensing practitioners
170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen
171 (a) means a prescription drug used to treat cancer manage its symptoms or provide
172 continuity of care for a cancer patient
173 (b) includes
174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal
175 methods and
176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize
177 physical and psychological symptoms or pain or to improve patient tolerance of cancer
178 treatments or prepare a patient for a subsequent course of therapy and
179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug
180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections
181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt
182 from licensure under this chapter
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HB106 02-05-14 122 PM
214 (ii) is acting under the direction of a prescribing practitioner who is immediately
215 available on site for any necessary consultation and who has complied with Subsection
216 (2)(b)(i)
217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the
218 outpatient clinic setting and
219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)
220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to
221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section
222 (b) The evaluation under this Subsection (3) shall include
223 (i) practitioner compliance with the requirements of this section and Section
224 58-l7b-309
225 (ii) current research on dispensing and patient safety
226 (iii) survey of other state dispensing laws and
227 (iv) recommendations for future action concerning practitioner dispensing
228 (c) The division shall report to the Legislatures Health and Human Services Interim
229 Committee by November 302012 and by November 302013 with the results and
230 recommendations from the evaluation required by this Subsection (3)
231 (4) This section sunsets in accordance with Section 631-1-258
232 Section 5 Section 58-17b-3097 is enacted to read
233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an
234 employer sponsored clinic
235 (1) As used in this section
236 (a) Employer sponsored clinic means an entity that offers health care only to the
237 employees of an exclusive group of employers and the employees dependents
238 (b) Health care is as defined in Section 31 A-J-301
239 (c) Prepackaged drug means a prescription drug that
240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and
241 (ii) is packaged in a fixed quantity per package by
242 (A) the drug manufacturer
243 (B) a pharmaceutical wholesaler or distributor or
244 (C) a pharmacy licensed under this title
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02-05-14 122 PM HB106
245 Cd) Prescribing practitioner is as defined in Section 58-17b-309
246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309
247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing
248 requirements of this chapter if the prescribing practitioner
249 Ca) treats an employee of one of an exclusive group of employers at an employer
250 sponsored clinic
251 Cb) prescribes a prepackaged drug to the employee
252 Cc) dispenses the prepackaged drug at the employer sponsored clinic
253 (d) notifies the division
254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the
255 employer sponsored clinic and
256 (ii) of the drug the prescribing practitioner intends to dispense
257 Ce) determines that providing the prepackaged drug to the employee at the employer
258 sponsored clinic is in the employees best interest
259 (f) informs the employee
260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner
261 from a pharmacy that is unaffiliated with the prescribing practitioner
262 (ii) of the directions for appropriate use of the prepackaged drug
263 (iii) of potential side effects to the use of the prepackaged drug and
264 (iv) how to contact the prescribing practitioner if the employee has questions or
265 concerns regarding the drug
266 (g) offers the employee the opportunity to consult with a pharmacist if the employee
267 asks for patient counseling and
268 (h) follows the administrative rules for a prescribing practitioner at an employer
269 sponsored clinic established by the division under Subsection (4)
270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a
271 prepackaged drug under this section requires physician supervision in its scope ofpractice
272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the
273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter
274 68 Utah Osteopathic Medical Practice Act
275 (4) The division shall in consultation with the board of pharmacy and the Physicians
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HBI06 02-05-14 122 PM
276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title
277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping
278 patient counseling purchasing and distribution operating treatment quality of care and
279 storage requirements for a prescribing practitioner at an employer sponsored clinic
280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a
281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing
282 practitioner is in compliance with this section
283 (6) If a prescribing practitioner violates a provision of this section the prescribing
284 practitioner may be subject to discipline under
285 (a) this chapter and
286 (b) any other chapter that governs the terms of the prescribing practitioners license
287 (7) The division shall evaluate the exemption created by this section and report to the
288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1
289 2018 on the results of the evaluation and the divisions recommendations regarding the
290 exemption
291 Section 6 Section 631-1-258 is amended to read
292 631-1-258 Repeal dates Title 58
293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is
294 repealed July 12016
295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015
296 (3) Section 58-17b-3095 is repealed July 1 2015
297 (4) Section 58-17b-3097 is repealed on July 12018
298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1
299 2018
300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1
301 2023
302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing
303 Act is repealed July 1 2019
304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1
305 2015
306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is
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02-05-14 1 22 PM HB106
307 repealed July 12023
308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1
309 2014
310 [ttej] ill) Section 58-69-3025 is repealed on July 12015
311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017
Legislative Review Note as of 2-3-14 418 PM
Office of Legislative Research and General Counsel
- 11 shy
02-06-14855 AM HB114
59 (9) Centralized prescription processing means the processing by a pharmacy of a
60 request from another pharmacy to fill or refill a prescription drug order or to perform
61 processing functions such as dispensing drug utilization review claims adjudication refill
62 authorizations and therapeutic interventions
63 (10) Class A pharmacy means a pharmacy located in Utah that is authorized as a
64 retail pharmacy to compound or dispense a drug or dispense a device to the public under a
65 prescription order
66 (11) Class B pharmacy
67 (a) means a pharmacy located in Utah
68 (i) that is authorized to provide pharmaceutical care for patients in an institutional
69 setting and
70 (ii) whose primary purpose is to provide a physical environment for patients to obtain
71 health care services and
72 (b) (i) includes closed-door hospital clinic nuclear and branch pharmacies and
73 (ii) pharmaceutical administration and sterile product preparation facilities
74 (12) Class C pharmacy means a pharmacy [located ill Utah that is anthOl ized to
75 engage] that engages in the manufacture production wholesale or distribution of drugs or
76 devices in Utah
77 (13) Class D pharmacy means a nonresident pharmacy
78 (14) Class E pharmacy means all other pharmacies
79 (15) Closed-door pharmacy means a pharmacy that provides pharmaceutical care to a
80 defined and exclusive group of patients who have access to the services of the pharmacy
81 because they are treated by or have an affiliation with a specific entity including a health
82 maintenance organization or an infusion company but not including a hospital pharmacy a
83 retailer of goods to the general public or the office of a practitioner
84 (16) Collaborative pharmacy practice means a practice of pharmacy whereby one or
85 more pharmacists have jointly agreed on a voluntary basis to work in conjunction with one or
86 more practitioners under protocol whereby the pharmacist may perform certain pharmaceutical
87 care functions authorized by the practitioner or practitioners under certain specified conditions
88 or limitations
89 (17) Collaborative pharmacy practice agreement means a written and signed
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02-06-14855 AM HB114
369 and
370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in
371 collaboration with the board
372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501
373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and
374 may be further defined by rule
375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that
376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration
377 for animals
378 Section 2 Effective date
379 This bill takes effect on July I 2014
Legislative Review Note as of 2-4-14 1243 PM
Office of Legislative Research and General Counsel
- 13 shy
LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t
t 02-05-14 122PM t
1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG
2 AMENDMENTS
3 2014 GENERAL SESSION
4 STATE OF UTAH
5 Chief Sponsor Stewart Barlow
6 Senate Sponsor
7
8 LONG TITLE
9 General Description
10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from
11 its licensing requirements under certain circumstances
12 Highlighted Provisions
13 This bill
14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy
15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an
16 employer sponsored clinic and complies with other requirements
17 repeals subject to sunset review the provisions of this bill relating to the exemption
18 described above and
19 ~ makes technical and conforming changes
20 Money Appropriated in this Bill
21 None
22 Other Special Clauses
23 None
24 Utah Code Sections Affected
25 AMENDS
26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~
27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull
1111111111111111111111111111111111111111
HBI06 02-05-14 122 PM
28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278
29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234
30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351
31 ENACTS
32 58-17b-3097 Utah Code Annotated 1953
33
34 Be it enacted by the Legislature ofthe state ofUtah
35 Section 1 Section 58-17b-301 is amended to read
36 58-17b-301 License required -- License classifications for individuals
37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the
38 practice of a pharmacy technician except as specifically provided in Section 58-1-307
39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097
40 (2) The division shall issue to an individual who qualifies under this chapter a license
41 in the classification of
42 (a) pharmacist
43 (b) pharmacy intern or
44 (c) pharmacy technician
45 Section 2 Section 58-17b-302 is amended to read
46 58-17b-302 License required -- License classifications for pharmacy facilities
47 (l) A license is required to act as a pharmacy except as specifically exempted from
48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or
49
50 (2) The division shall issue a pharmacy license to a facility that qualifies under this
51 chapter in the classification of a
52 (a) class A pharmacy
53 (b) class B pharmacy
54 (c) class C pharmacy
55 (d) class D pharmacy or
56 (e) class E pharmacy
57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist
58 at the same address a separate license shall be required for each pharmacy
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02-05-14 122 PM HBI06
59 (4) The division may further define or supplement the classifications of pharmacies
60 The division may impose restrictions upon classifications to protect the public health safety
61 and welfare
62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by
63 rule
64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy
65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities
66 of the pharmacy regardless of the form of the business organization
67 Section 3 Section 58-17b-309 is amended to read
68 58-17b-309 Exemptions from licensure
69 (l) [For ptnp05C5 of] As used in this section
70 (a) Cosmetic drug
71 (i) means a prescription drug that is
72 (A) for the purpose of promoting attractiveness or altering the appearance of an
73 individual and
74 (8) listed as a cosmetic drug subject to the exemption under this section by the division
75 by administrative rule or has been expressly approved for online dispensing whether or not it is
76 dispensed online or through a physicians office and
77 (ii) does not include a prescription drug that is
78 (A) a controlled substance
79 (8) compounded by the physician or
80 (C) prescribed or used for the patient for the purpose of diagnosing curing or
81 preventing a disease
82 (b) Injectable weight loss drug
83 (i) means an injectable prescription drug
84 (A) prescribed to promote weight loss and
85 (8) listed as an injectable prescription drug subject to exemption under this section by
86 the division by administrative rule and
87 (ii) does not include a prescription drug that is a controlled substance
88 (c) Prescribing practitioner means an individual licensed under
89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with
- 3 shy
HB106 02-05-14 122 PM
90 prescriptive practice
91 (ii) Chapter 67 Utah Medical Practice Act
92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or
93 (iv) Chapter 70a Physician Assistant Act
94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l
95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the
96 acts or practices described in this section without being licensed under this chapter
97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the
98 individual notifies the division in writing of the individuals intent to dispense a drug under this
99 [snbsectioll] Subsection (2)
100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1
101 (c) an individual engaging in the practice of pharmacy technician under the direct
102 personal supervision of a pharmacist while making satisfactory progress in an approved
103 program as defined in division rule
104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an
105 injectable weight loss drug to the prescribing practitioners patient in accordance with
106 Subsection (4) or
107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists
108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic
109 drug to the optometrists patient in accordance with Subsection (4)
110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under
111 Subsection (2)( c) must take all examinations as required by division rule following completion
112 of an approved curriculum of education within the required time frame This exemption
113 expires immediately upon notification of a failing score of an examination and the individual
114 may not continue working as a pharmacy technician even under direct supervision
115 (4) A prescribing practitioner or optometrist is exempt from licensing under the
116 provisions of this part if the prescribing practitioner or optometrist
117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the
118 authority to dispense under Subsection (4)(b) and
119 (ii) informs the patient
120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing
-4shy
HB106 02-05-14 122 PM
152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the
153 prescribing practitioners or optometrists office and determine if the provisions of this section
154 are being met by the prescribing practitioner or optometrist
155 (d) If a prescribing practitioner or optometrist violates a provision of this section the
156 prescribing practitioner or optometrist may be subject to discipline under
157 (i) this chapter and
158 (ii) (A) Chapter 16a Utah Optometry Practice Act
159 (B) Chapter 31 b Nurse Practice Act
160 (C) Chapter 67 Utah Medical Practice Act
161 (D) Chapter 68 Utah Osteopathic Medical Practice Act
162 (E) Chapter 70a Physician Assistant Act or
163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act
164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the
165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah
166 Optometry Practice Act
167 Section 4 Section 58-17b-3095 is amended to read
168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy
169 Division study of dispensing practitioners
170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen
171 (a) means a prescription drug used to treat cancer manage its symptoms or provide
172 continuity of care for a cancer patient
173 (b) includes
174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal
175 methods and
176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize
177 physical and psychological symptoms or pain or to improve patient tolerance of cancer
178 treatments or prepare a patient for a subsequent course of therapy and
179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug
180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections
181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt
182 from licensure under this chapter
- 6shy
HB106 02-05-14 122 PM
214 (ii) is acting under the direction of a prescribing practitioner who is immediately
215 available on site for any necessary consultation and who has complied with Subsection
216 (2)(b)(i)
217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the
218 outpatient clinic setting and
219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)
220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to
221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section
222 (b) The evaluation under this Subsection (3) shall include
223 (i) practitioner compliance with the requirements of this section and Section
224 58-l7b-309
225 (ii) current research on dispensing and patient safety
226 (iii) survey of other state dispensing laws and
227 (iv) recommendations for future action concerning practitioner dispensing
228 (c) The division shall report to the Legislatures Health and Human Services Interim
229 Committee by November 302012 and by November 302013 with the results and
230 recommendations from the evaluation required by this Subsection (3)
231 (4) This section sunsets in accordance with Section 631-1-258
232 Section 5 Section 58-17b-3097 is enacted to read
233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an
234 employer sponsored clinic
235 (1) As used in this section
236 (a) Employer sponsored clinic means an entity that offers health care only to the
237 employees of an exclusive group of employers and the employees dependents
238 (b) Health care is as defined in Section 31 A-J-301
239 (c) Prepackaged drug means a prescription drug that
240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and
241 (ii) is packaged in a fixed quantity per package by
242 (A) the drug manufacturer
243 (B) a pharmaceutical wholesaler or distributor or
244 (C) a pharmacy licensed under this title
- 8 shy
~ -- -------------------
02-05-14 122 PM HB106
245 Cd) Prescribing practitioner is as defined in Section 58-17b-309
246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309
247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing
248 requirements of this chapter if the prescribing practitioner
249 Ca) treats an employee of one of an exclusive group of employers at an employer
250 sponsored clinic
251 Cb) prescribes a prepackaged drug to the employee
252 Cc) dispenses the prepackaged drug at the employer sponsored clinic
253 (d) notifies the division
254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the
255 employer sponsored clinic and
256 (ii) of the drug the prescribing practitioner intends to dispense
257 Ce) determines that providing the prepackaged drug to the employee at the employer
258 sponsored clinic is in the employees best interest
259 (f) informs the employee
260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner
261 from a pharmacy that is unaffiliated with the prescribing practitioner
262 (ii) of the directions for appropriate use of the prepackaged drug
263 (iii) of potential side effects to the use of the prepackaged drug and
264 (iv) how to contact the prescribing practitioner if the employee has questions or
265 concerns regarding the drug
266 (g) offers the employee the opportunity to consult with a pharmacist if the employee
267 asks for patient counseling and
268 (h) follows the administrative rules for a prescribing practitioner at an employer
269 sponsored clinic established by the division under Subsection (4)
270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a
271 prepackaged drug under this section requires physician supervision in its scope ofpractice
272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the
273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter
274 68 Utah Osteopathic Medical Practice Act
275 (4) The division shall in consultation with the board of pharmacy and the Physicians
- 9 shy
HBI06 02-05-14 122 PM
276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title
277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping
278 patient counseling purchasing and distribution operating treatment quality of care and
279 storage requirements for a prescribing practitioner at an employer sponsored clinic
280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a
281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing
282 practitioner is in compliance with this section
283 (6) If a prescribing practitioner violates a provision of this section the prescribing
284 practitioner may be subject to discipline under
285 (a) this chapter and
286 (b) any other chapter that governs the terms of the prescribing practitioners license
287 (7) The division shall evaluate the exemption created by this section and report to the
288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1
289 2018 on the results of the evaluation and the divisions recommendations regarding the
290 exemption
291 Section 6 Section 631-1-258 is amended to read
292 631-1-258 Repeal dates Title 58
293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is
294 repealed July 12016
295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015
296 (3) Section 58-17b-3095 is repealed July 1 2015
297 (4) Section 58-17b-3097 is repealed on July 12018
298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1
299 2018
300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1
301 2023
302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing
303 Act is repealed July 1 2019
304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1
305 2015
306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is
- 10shy
02-05-14 1 22 PM HB106
307 repealed July 12023
308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1
309 2014
310 [ttej] ill) Section 58-69-3025 is repealed on July 12015
311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017
Legislative Review Note as of 2-3-14 418 PM
Office of Legislative Research and General Counsel
- 11 shy
02-06-14855 AM HB114
369 and
370 (b) are supervised by a pharmacist in accordance with rules adopted by the division in
371 collaboration with the board
372 (67) Unlawful conduct is as defined in Sections 58-1-501 and 58-l7b-501
373 (68) Unprofessional conduct is as defined in Sections 58-1-501 and 58-17b-502 and
374 may be further defined by rule
375 (69) Veterinary pharmaceutical facility means a pharmaceutical facility that
376 dispenses drugs intended for use by animals or for sale to veterinarians for the administration
377 for animals
378 Section 2 Effective date
379 This bill takes effect on July I 2014
Legislative Review Note as of 2-4-14 1243 PM
Office of Legislative Research and General Counsel
- 13 shy
LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t
t 02-05-14 122PM t
1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG
2 AMENDMENTS
3 2014 GENERAL SESSION
4 STATE OF UTAH
5 Chief Sponsor Stewart Barlow
6 Senate Sponsor
7
8 LONG TITLE
9 General Description
10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from
11 its licensing requirements under certain circumstances
12 Highlighted Provisions
13 This bill
14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy
15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an
16 employer sponsored clinic and complies with other requirements
17 repeals subject to sunset review the provisions of this bill relating to the exemption
18 described above and
19 ~ makes technical and conforming changes
20 Money Appropriated in this Bill
21 None
22 Other Special Clauses
23 None
24 Utah Code Sections Affected
25 AMENDS
26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~
27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull
1111111111111111111111111111111111111111
HBI06 02-05-14 122 PM
28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278
29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234
30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351
31 ENACTS
32 58-17b-3097 Utah Code Annotated 1953
33
34 Be it enacted by the Legislature ofthe state ofUtah
35 Section 1 Section 58-17b-301 is amended to read
36 58-17b-301 License required -- License classifications for individuals
37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the
38 practice of a pharmacy technician except as specifically provided in Section 58-1-307
39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097
40 (2) The division shall issue to an individual who qualifies under this chapter a license
41 in the classification of
42 (a) pharmacist
43 (b) pharmacy intern or
44 (c) pharmacy technician
45 Section 2 Section 58-17b-302 is amended to read
46 58-17b-302 License required -- License classifications for pharmacy facilities
47 (l) A license is required to act as a pharmacy except as specifically exempted from
48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or
49
50 (2) The division shall issue a pharmacy license to a facility that qualifies under this
51 chapter in the classification of a
52 (a) class A pharmacy
53 (b) class B pharmacy
54 (c) class C pharmacy
55 (d) class D pharmacy or
56 (e) class E pharmacy
57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist
58 at the same address a separate license shall be required for each pharmacy
-2shy
02-05-14 122 PM HBI06
59 (4) The division may further define or supplement the classifications of pharmacies
60 The division may impose restrictions upon classifications to protect the public health safety
61 and welfare
62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by
63 rule
64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy
65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities
66 of the pharmacy regardless of the form of the business organization
67 Section 3 Section 58-17b-309 is amended to read
68 58-17b-309 Exemptions from licensure
69 (l) [For ptnp05C5 of] As used in this section
70 (a) Cosmetic drug
71 (i) means a prescription drug that is
72 (A) for the purpose of promoting attractiveness or altering the appearance of an
73 individual and
74 (8) listed as a cosmetic drug subject to the exemption under this section by the division
75 by administrative rule or has been expressly approved for online dispensing whether or not it is
76 dispensed online or through a physicians office and
77 (ii) does not include a prescription drug that is
78 (A) a controlled substance
79 (8) compounded by the physician or
80 (C) prescribed or used for the patient for the purpose of diagnosing curing or
81 preventing a disease
82 (b) Injectable weight loss drug
83 (i) means an injectable prescription drug
84 (A) prescribed to promote weight loss and
85 (8) listed as an injectable prescription drug subject to exemption under this section by
86 the division by administrative rule and
87 (ii) does not include a prescription drug that is a controlled substance
88 (c) Prescribing practitioner means an individual licensed under
89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with
- 3 shy
HB106 02-05-14 122 PM
90 prescriptive practice
91 (ii) Chapter 67 Utah Medical Practice Act
92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or
93 (iv) Chapter 70a Physician Assistant Act
94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l
95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the
96 acts or practices described in this section without being licensed under this chapter
97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the
98 individual notifies the division in writing of the individuals intent to dispense a drug under this
99 [snbsectioll] Subsection (2)
100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1
101 (c) an individual engaging in the practice of pharmacy technician under the direct
102 personal supervision of a pharmacist while making satisfactory progress in an approved
103 program as defined in division rule
104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an
105 injectable weight loss drug to the prescribing practitioners patient in accordance with
106 Subsection (4) or
107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists
108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic
109 drug to the optometrists patient in accordance with Subsection (4)
110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under
111 Subsection (2)( c) must take all examinations as required by division rule following completion
112 of an approved curriculum of education within the required time frame This exemption
113 expires immediately upon notification of a failing score of an examination and the individual
114 may not continue working as a pharmacy technician even under direct supervision
115 (4) A prescribing practitioner or optometrist is exempt from licensing under the
116 provisions of this part if the prescribing practitioner or optometrist
117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the
118 authority to dispense under Subsection (4)(b) and
119 (ii) informs the patient
120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing
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HB106 02-05-14 122 PM
152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the
153 prescribing practitioners or optometrists office and determine if the provisions of this section
154 are being met by the prescribing practitioner or optometrist
155 (d) If a prescribing practitioner or optometrist violates a provision of this section the
156 prescribing practitioner or optometrist may be subject to discipline under
157 (i) this chapter and
158 (ii) (A) Chapter 16a Utah Optometry Practice Act
159 (B) Chapter 31 b Nurse Practice Act
160 (C) Chapter 67 Utah Medical Practice Act
161 (D) Chapter 68 Utah Osteopathic Medical Practice Act
162 (E) Chapter 70a Physician Assistant Act or
163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act
164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the
165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah
166 Optometry Practice Act
167 Section 4 Section 58-17b-3095 is amended to read
168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy
169 Division study of dispensing practitioners
170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen
171 (a) means a prescription drug used to treat cancer manage its symptoms or provide
172 continuity of care for a cancer patient
173 (b) includes
174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal
175 methods and
176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize
177 physical and psychological symptoms or pain or to improve patient tolerance of cancer
178 treatments or prepare a patient for a subsequent course of therapy and
179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug
180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections
181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt
182 from licensure under this chapter
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HB106 02-05-14 122 PM
214 (ii) is acting under the direction of a prescribing practitioner who is immediately
215 available on site for any necessary consultation and who has complied with Subsection
216 (2)(b)(i)
217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the
218 outpatient clinic setting and
219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)
220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to
221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section
222 (b) The evaluation under this Subsection (3) shall include
223 (i) practitioner compliance with the requirements of this section and Section
224 58-l7b-309
225 (ii) current research on dispensing and patient safety
226 (iii) survey of other state dispensing laws and
227 (iv) recommendations for future action concerning practitioner dispensing
228 (c) The division shall report to the Legislatures Health and Human Services Interim
229 Committee by November 302012 and by November 302013 with the results and
230 recommendations from the evaluation required by this Subsection (3)
231 (4) This section sunsets in accordance with Section 631-1-258
232 Section 5 Section 58-17b-3097 is enacted to read
233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an
234 employer sponsored clinic
235 (1) As used in this section
236 (a) Employer sponsored clinic means an entity that offers health care only to the
237 employees of an exclusive group of employers and the employees dependents
238 (b) Health care is as defined in Section 31 A-J-301
239 (c) Prepackaged drug means a prescription drug that
240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and
241 (ii) is packaged in a fixed quantity per package by
242 (A) the drug manufacturer
243 (B) a pharmaceutical wholesaler or distributor or
244 (C) a pharmacy licensed under this title
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~ -- -------------------
02-05-14 122 PM HB106
245 Cd) Prescribing practitioner is as defined in Section 58-17b-309
246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309
247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing
248 requirements of this chapter if the prescribing practitioner
249 Ca) treats an employee of one of an exclusive group of employers at an employer
250 sponsored clinic
251 Cb) prescribes a prepackaged drug to the employee
252 Cc) dispenses the prepackaged drug at the employer sponsored clinic
253 (d) notifies the division
254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the
255 employer sponsored clinic and
256 (ii) of the drug the prescribing practitioner intends to dispense
257 Ce) determines that providing the prepackaged drug to the employee at the employer
258 sponsored clinic is in the employees best interest
259 (f) informs the employee
260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner
261 from a pharmacy that is unaffiliated with the prescribing practitioner
262 (ii) of the directions for appropriate use of the prepackaged drug
263 (iii) of potential side effects to the use of the prepackaged drug and
264 (iv) how to contact the prescribing practitioner if the employee has questions or
265 concerns regarding the drug
266 (g) offers the employee the opportunity to consult with a pharmacist if the employee
267 asks for patient counseling and
268 (h) follows the administrative rules for a prescribing practitioner at an employer
269 sponsored clinic established by the division under Subsection (4)
270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a
271 prepackaged drug under this section requires physician supervision in its scope ofpractice
272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the
273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter
274 68 Utah Osteopathic Medical Practice Act
275 (4) The division shall in consultation with the board of pharmacy and the Physicians
- 9 shy
HBI06 02-05-14 122 PM
276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title
277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping
278 patient counseling purchasing and distribution operating treatment quality of care and
279 storage requirements for a prescribing practitioner at an employer sponsored clinic
280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a
281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing
282 practitioner is in compliance with this section
283 (6) If a prescribing practitioner violates a provision of this section the prescribing
284 practitioner may be subject to discipline under
285 (a) this chapter and
286 (b) any other chapter that governs the terms of the prescribing practitioners license
287 (7) The division shall evaluate the exemption created by this section and report to the
288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1
289 2018 on the results of the evaluation and the divisions recommendations regarding the
290 exemption
291 Section 6 Section 631-1-258 is amended to read
292 631-1-258 Repeal dates Title 58
293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is
294 repealed July 12016
295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015
296 (3) Section 58-17b-3095 is repealed July 1 2015
297 (4) Section 58-17b-3097 is repealed on July 12018
298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1
299 2018
300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1
301 2023
302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing
303 Act is repealed July 1 2019
304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1
305 2015
306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is
- 10shy
02-05-14 1 22 PM HB106
307 repealed July 12023
308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1
309 2014
310 [ttej] ill) Section 58-69-3025 is repealed on July 12015
311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017
Legislative Review Note as of 2-3-14 418 PM
Office of Legislative Research and General Counsel
- 11 shy
LEGISLATIVE GENERAL COUNSEL HBI06 t Approved for Filing Sc Johnston t
t 02-05-14 122PM t
1 EMPLOYER SPONSORED CLINIC - PRESCRIPTION DRUG
2 AMENDMENTS
3 2014 GENERAL SESSION
4 STATE OF UTAH
5 Chief Sponsor Stewart Barlow
6 Senate Sponsor
7
8 LONG TITLE
9 General Description
10 This bill amends the Pharmacy Practice Act to exempt a prescribing practitioner from
11 its licensing requirements under certain circumstances
12 Highlighted Provisions
13 This bill
14 ~ exempts a prescribing practitioner from the licensing requirements of the Pharmacy
15 Practice Act if the prescribing practitioner dispenses a prepackaged drug at an
16 employer sponsored clinic and complies with other requirements
17 repeals subject to sunset review the provisions of this bill relating to the exemption
18 described above and
19 ~ makes technical and conforming changes
20 Money Appropriated in this Bill
21 None
22 Other Special Clauses
23 None
24 Utah Code Sections Affected
25 AMENDS
26 58-17b-301 as last amended by Laws of Utah 2013 Chapter 52 ==bull ~
27 58-17b-302 as last amended by Laws of Utah 2013 Chapter 52 bull
1111111111111111111111111111111111111111
HBI06 02-05-14 122 PM
28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278
29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234
30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351
31 ENACTS
32 58-17b-3097 Utah Code Annotated 1953
33
34 Be it enacted by the Legislature ofthe state ofUtah
35 Section 1 Section 58-17b-301 is amended to read
36 58-17b-301 License required -- License classifications for individuals
37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the
38 practice of a pharmacy technician except as specifically provided in Section 58-1-307
39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097
40 (2) The division shall issue to an individual who qualifies under this chapter a license
41 in the classification of
42 (a) pharmacist
43 (b) pharmacy intern or
44 (c) pharmacy technician
45 Section 2 Section 58-17b-302 is amended to read
46 58-17b-302 License required -- License classifications for pharmacy facilities
47 (l) A license is required to act as a pharmacy except as specifically exempted from
48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or
49
50 (2) The division shall issue a pharmacy license to a facility that qualifies under this
51 chapter in the classification of a
52 (a) class A pharmacy
53 (b) class B pharmacy
54 (c) class C pharmacy
55 (d) class D pharmacy or
56 (e) class E pharmacy
57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist
58 at the same address a separate license shall be required for each pharmacy
-2shy
02-05-14 122 PM HBI06
59 (4) The division may further define or supplement the classifications of pharmacies
60 The division may impose restrictions upon classifications to protect the public health safety
61 and welfare
62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by
63 rule
64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy
65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities
66 of the pharmacy regardless of the form of the business organization
67 Section 3 Section 58-17b-309 is amended to read
68 58-17b-309 Exemptions from licensure
69 (l) [For ptnp05C5 of] As used in this section
70 (a) Cosmetic drug
71 (i) means a prescription drug that is
72 (A) for the purpose of promoting attractiveness or altering the appearance of an
73 individual and
74 (8) listed as a cosmetic drug subject to the exemption under this section by the division
75 by administrative rule or has been expressly approved for online dispensing whether or not it is
76 dispensed online or through a physicians office and
77 (ii) does not include a prescription drug that is
78 (A) a controlled substance
79 (8) compounded by the physician or
80 (C) prescribed or used for the patient for the purpose of diagnosing curing or
81 preventing a disease
82 (b) Injectable weight loss drug
83 (i) means an injectable prescription drug
84 (A) prescribed to promote weight loss and
85 (8) listed as an injectable prescription drug subject to exemption under this section by
86 the division by administrative rule and
87 (ii) does not include a prescription drug that is a controlled substance
88 (c) Prescribing practitioner means an individual licensed under
89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with
- 3 shy
HB106 02-05-14 122 PM
90 prescriptive practice
91 (ii) Chapter 67 Utah Medical Practice Act
92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or
93 (iv) Chapter 70a Physician Assistant Act
94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l
95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the
96 acts or practices described in this section without being licensed under this chapter
97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the
98 individual notifies the division in writing of the individuals intent to dispense a drug under this
99 [snbsectioll] Subsection (2)
100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1
101 (c) an individual engaging in the practice of pharmacy technician under the direct
102 personal supervision of a pharmacist while making satisfactory progress in an approved
103 program as defined in division rule
104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an
105 injectable weight loss drug to the prescribing practitioners patient in accordance with
106 Subsection (4) or
107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists
108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic
109 drug to the optometrists patient in accordance with Subsection (4)
110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under
111 Subsection (2)( c) must take all examinations as required by division rule following completion
112 of an approved curriculum of education within the required time frame This exemption
113 expires immediately upon notification of a failing score of an examination and the individual
114 may not continue working as a pharmacy technician even under direct supervision
115 (4) A prescribing practitioner or optometrist is exempt from licensing under the
116 provisions of this part if the prescribing practitioner or optometrist
117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the
118 authority to dispense under Subsection (4)(b) and
119 (ii) informs the patient
120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing
-4shy
HB106 02-05-14 122 PM
152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the
153 prescribing practitioners or optometrists office and determine if the provisions of this section
154 are being met by the prescribing practitioner or optometrist
155 (d) If a prescribing practitioner or optometrist violates a provision of this section the
156 prescribing practitioner or optometrist may be subject to discipline under
157 (i) this chapter and
158 (ii) (A) Chapter 16a Utah Optometry Practice Act
159 (B) Chapter 31 b Nurse Practice Act
160 (C) Chapter 67 Utah Medical Practice Act
161 (D) Chapter 68 Utah Osteopathic Medical Practice Act
162 (E) Chapter 70a Physician Assistant Act or
163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act
164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the
165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah
166 Optometry Practice Act
167 Section 4 Section 58-17b-3095 is amended to read
168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy
169 Division study of dispensing practitioners
170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen
171 (a) means a prescription drug used to treat cancer manage its symptoms or provide
172 continuity of care for a cancer patient
173 (b) includes
174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal
175 methods and
176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize
177 physical and psychological symptoms or pain or to improve patient tolerance of cancer
178 treatments or prepare a patient for a subsequent course of therapy and
179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug
180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections
181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt
182 from licensure under this chapter
- 6shy
HB106 02-05-14 122 PM
214 (ii) is acting under the direction of a prescribing practitioner who is immediately
215 available on site for any necessary consultation and who has complied with Subsection
216 (2)(b)(i)
217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the
218 outpatient clinic setting and
219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)
220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to
221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section
222 (b) The evaluation under this Subsection (3) shall include
223 (i) practitioner compliance with the requirements of this section and Section
224 58-l7b-309
225 (ii) current research on dispensing and patient safety
226 (iii) survey of other state dispensing laws and
227 (iv) recommendations for future action concerning practitioner dispensing
228 (c) The division shall report to the Legislatures Health and Human Services Interim
229 Committee by November 302012 and by November 302013 with the results and
230 recommendations from the evaluation required by this Subsection (3)
231 (4) This section sunsets in accordance with Section 631-1-258
232 Section 5 Section 58-17b-3097 is enacted to read
233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an
234 employer sponsored clinic
235 (1) As used in this section
236 (a) Employer sponsored clinic means an entity that offers health care only to the
237 employees of an exclusive group of employers and the employees dependents
238 (b) Health care is as defined in Section 31 A-J-301
239 (c) Prepackaged drug means a prescription drug that
240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and
241 (ii) is packaged in a fixed quantity per package by
242 (A) the drug manufacturer
243 (B) a pharmaceutical wholesaler or distributor or
244 (C) a pharmacy licensed under this title
- 8 shy
~ -- -------------------
02-05-14 122 PM HB106
245 Cd) Prescribing practitioner is as defined in Section 58-17b-309
246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309
247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing
248 requirements of this chapter if the prescribing practitioner
249 Ca) treats an employee of one of an exclusive group of employers at an employer
250 sponsored clinic
251 Cb) prescribes a prepackaged drug to the employee
252 Cc) dispenses the prepackaged drug at the employer sponsored clinic
253 (d) notifies the division
254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the
255 employer sponsored clinic and
256 (ii) of the drug the prescribing practitioner intends to dispense
257 Ce) determines that providing the prepackaged drug to the employee at the employer
258 sponsored clinic is in the employees best interest
259 (f) informs the employee
260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner
261 from a pharmacy that is unaffiliated with the prescribing practitioner
262 (ii) of the directions for appropriate use of the prepackaged drug
263 (iii) of potential side effects to the use of the prepackaged drug and
264 (iv) how to contact the prescribing practitioner if the employee has questions or
265 concerns regarding the drug
266 (g) offers the employee the opportunity to consult with a pharmacist if the employee
267 asks for patient counseling and
268 (h) follows the administrative rules for a prescribing practitioner at an employer
269 sponsored clinic established by the division under Subsection (4)
270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a
271 prepackaged drug under this section requires physician supervision in its scope ofpractice
272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the
273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter
274 68 Utah Osteopathic Medical Practice Act
275 (4) The division shall in consultation with the board of pharmacy and the Physicians
- 9 shy
HBI06 02-05-14 122 PM
276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title
277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping
278 patient counseling purchasing and distribution operating treatment quality of care and
279 storage requirements for a prescribing practitioner at an employer sponsored clinic
280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a
281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing
282 practitioner is in compliance with this section
283 (6) If a prescribing practitioner violates a provision of this section the prescribing
284 practitioner may be subject to discipline under
285 (a) this chapter and
286 (b) any other chapter that governs the terms of the prescribing practitioners license
287 (7) The division shall evaluate the exemption created by this section and report to the
288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1
289 2018 on the results of the evaluation and the divisions recommendations regarding the
290 exemption
291 Section 6 Section 631-1-258 is amended to read
292 631-1-258 Repeal dates Title 58
293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is
294 repealed July 12016
295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015
296 (3) Section 58-17b-3095 is repealed July 1 2015
297 (4) Section 58-17b-3097 is repealed on July 12018
298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1
299 2018
300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1
301 2023
302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing
303 Act is repealed July 1 2019
304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1
305 2015
306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is
- 10shy
02-05-14 1 22 PM HB106
307 repealed July 12023
308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1
309 2014
310 [ttej] ill) Section 58-69-3025 is repealed on July 12015
311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017
Legislative Review Note as of 2-3-14 418 PM
Office of Legislative Research and General Counsel
- 11 shy
HBI06 02-05-14 122 PM
28 58-17b-309 as last amended by Laws of Utah 2013 Chapter 278
29 58-17b-3095 as enacted by Laws of Utah 2012 Chapter 234
30 631-1-258 as last amended by Laws of Utah 2013 Chapters 55 87222278 and 351
31 ENACTS
32 58-17b-3097 Utah Code Annotated 1953
33
34 Be it enacted by the Legislature ofthe state ofUtah
35 Section 1 Section 58-17b-301 is amended to read
36 58-17b-301 License required -- License classifications for individuals
37 (1) A license is required to engage in the practice of pharmacy telepharmacy or the
38 practice of a pharmacy technician except as specifically provided in Section 58-1-307
39 58-17b-309 [or] 58-17b-3095 58-17-3096 or 58-17b-3097
40 (2) The division shall issue to an individual who qualifies under this chapter a license
41 in the classification of
42 (a) pharmacist
43 (b) pharmacy intern or
44 (c) pharmacy technician
45 Section 2 Section 58-17b-302 is amended to read
46 58-17b-302 License required -- License classifications for pharmacy facilities
47 (l) A license is required to act as a pharmacy except as specifically exempted from
48 licensure under Section 58-1-307 [or] 58-17b-309 58-17b-3095 58-17-3096 or
49
50 (2) The division shall issue a pharmacy license to a facility that qualifies under this
51 chapter in the classification of a
52 (a) class A pharmacy
53 (b) class B pharmacy
54 (c) class C pharmacy
55 (d) class D pharmacy or
56 (e) class E pharmacy
57 (3) Each place of business shall require a separate license Ifmultiple pharmacies exist
58 at the same address a separate license shall be required for each pharmacy
-2shy
02-05-14 122 PM HBI06
59 (4) The division may further define or supplement the classifications of pharmacies
60 The division may impose restrictions upon classifications to protect the public health safety
61 and welfare
62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by
63 rule
64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy
65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities
66 of the pharmacy regardless of the form of the business organization
67 Section 3 Section 58-17b-309 is amended to read
68 58-17b-309 Exemptions from licensure
69 (l) [For ptnp05C5 of] As used in this section
70 (a) Cosmetic drug
71 (i) means a prescription drug that is
72 (A) for the purpose of promoting attractiveness or altering the appearance of an
73 individual and
74 (8) listed as a cosmetic drug subject to the exemption under this section by the division
75 by administrative rule or has been expressly approved for online dispensing whether or not it is
76 dispensed online or through a physicians office and
77 (ii) does not include a prescription drug that is
78 (A) a controlled substance
79 (8) compounded by the physician or
80 (C) prescribed or used for the patient for the purpose of diagnosing curing or
81 preventing a disease
82 (b) Injectable weight loss drug
83 (i) means an injectable prescription drug
84 (A) prescribed to promote weight loss and
85 (8) listed as an injectable prescription drug subject to exemption under this section by
86 the division by administrative rule and
87 (ii) does not include a prescription drug that is a controlled substance
88 (c) Prescribing practitioner means an individual licensed under
89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with
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HB106 02-05-14 122 PM
90 prescriptive practice
91 (ii) Chapter 67 Utah Medical Practice Act
92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or
93 (iv) Chapter 70a Physician Assistant Act
94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l
95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the
96 acts or practices described in this section without being licensed under this chapter
97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the
98 individual notifies the division in writing of the individuals intent to dispense a drug under this
99 [snbsectioll] Subsection (2)
100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1
101 (c) an individual engaging in the practice of pharmacy technician under the direct
102 personal supervision of a pharmacist while making satisfactory progress in an approved
103 program as defined in division rule
104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an
105 injectable weight loss drug to the prescribing practitioners patient in accordance with
106 Subsection (4) or
107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists
108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic
109 drug to the optometrists patient in accordance with Subsection (4)
110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under
111 Subsection (2)( c) must take all examinations as required by division rule following completion
112 of an approved curriculum of education within the required time frame This exemption
113 expires immediately upon notification of a failing score of an examination and the individual
114 may not continue working as a pharmacy technician even under direct supervision
115 (4) A prescribing practitioner or optometrist is exempt from licensing under the
116 provisions of this part if the prescribing practitioner or optometrist
117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the
118 authority to dispense under Subsection (4)(b) and
119 (ii) informs the patient
120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing
-4shy
HB106 02-05-14 122 PM
152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the
153 prescribing practitioners or optometrists office and determine if the provisions of this section
154 are being met by the prescribing practitioner or optometrist
155 (d) If a prescribing practitioner or optometrist violates a provision of this section the
156 prescribing practitioner or optometrist may be subject to discipline under
157 (i) this chapter and
158 (ii) (A) Chapter 16a Utah Optometry Practice Act
159 (B) Chapter 31 b Nurse Practice Act
160 (C) Chapter 67 Utah Medical Practice Act
161 (D) Chapter 68 Utah Osteopathic Medical Practice Act
162 (E) Chapter 70a Physician Assistant Act or
163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act
164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the
165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah
166 Optometry Practice Act
167 Section 4 Section 58-17b-3095 is amended to read
168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy
169 Division study of dispensing practitioners
170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen
171 (a) means a prescription drug used to treat cancer manage its symptoms or provide
172 continuity of care for a cancer patient
173 (b) includes
174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal
175 methods and
176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize
177 physical and psychological symptoms or pain or to improve patient tolerance of cancer
178 treatments or prepare a patient for a subsequent course of therapy and
179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug
180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections
181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt
182 from licensure under this chapter
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HB106 02-05-14 122 PM
214 (ii) is acting under the direction of a prescribing practitioner who is immediately
215 available on site for any necessary consultation and who has complied with Subsection
216 (2)(b)(i)
217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the
218 outpatient clinic setting and
219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)
220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to
221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section
222 (b) The evaluation under this Subsection (3) shall include
223 (i) practitioner compliance with the requirements of this section and Section
224 58-l7b-309
225 (ii) current research on dispensing and patient safety
226 (iii) survey of other state dispensing laws and
227 (iv) recommendations for future action concerning practitioner dispensing
228 (c) The division shall report to the Legislatures Health and Human Services Interim
229 Committee by November 302012 and by November 302013 with the results and
230 recommendations from the evaluation required by this Subsection (3)
231 (4) This section sunsets in accordance with Section 631-1-258
232 Section 5 Section 58-17b-3097 is enacted to read
233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an
234 employer sponsored clinic
235 (1) As used in this section
236 (a) Employer sponsored clinic means an entity that offers health care only to the
237 employees of an exclusive group of employers and the employees dependents
238 (b) Health care is as defined in Section 31 A-J-301
239 (c) Prepackaged drug means a prescription drug that
240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and
241 (ii) is packaged in a fixed quantity per package by
242 (A) the drug manufacturer
243 (B) a pharmaceutical wholesaler or distributor or
244 (C) a pharmacy licensed under this title
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02-05-14 122 PM HB106
245 Cd) Prescribing practitioner is as defined in Section 58-17b-309
246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309
247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing
248 requirements of this chapter if the prescribing practitioner
249 Ca) treats an employee of one of an exclusive group of employers at an employer
250 sponsored clinic
251 Cb) prescribes a prepackaged drug to the employee
252 Cc) dispenses the prepackaged drug at the employer sponsored clinic
253 (d) notifies the division
254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the
255 employer sponsored clinic and
256 (ii) of the drug the prescribing practitioner intends to dispense
257 Ce) determines that providing the prepackaged drug to the employee at the employer
258 sponsored clinic is in the employees best interest
259 (f) informs the employee
260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner
261 from a pharmacy that is unaffiliated with the prescribing practitioner
262 (ii) of the directions for appropriate use of the prepackaged drug
263 (iii) of potential side effects to the use of the prepackaged drug and
264 (iv) how to contact the prescribing practitioner if the employee has questions or
265 concerns regarding the drug
266 (g) offers the employee the opportunity to consult with a pharmacist if the employee
267 asks for patient counseling and
268 (h) follows the administrative rules for a prescribing practitioner at an employer
269 sponsored clinic established by the division under Subsection (4)
270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a
271 prepackaged drug under this section requires physician supervision in its scope ofpractice
272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the
273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter
274 68 Utah Osteopathic Medical Practice Act
275 (4) The division shall in consultation with the board of pharmacy and the Physicians
- 9 shy
HBI06 02-05-14 122 PM
276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title
277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping
278 patient counseling purchasing and distribution operating treatment quality of care and
279 storage requirements for a prescribing practitioner at an employer sponsored clinic
280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a
281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing
282 practitioner is in compliance with this section
283 (6) If a prescribing practitioner violates a provision of this section the prescribing
284 practitioner may be subject to discipline under
285 (a) this chapter and
286 (b) any other chapter that governs the terms of the prescribing practitioners license
287 (7) The division shall evaluate the exemption created by this section and report to the
288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1
289 2018 on the results of the evaluation and the divisions recommendations regarding the
290 exemption
291 Section 6 Section 631-1-258 is amended to read
292 631-1-258 Repeal dates Title 58
293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is
294 repealed July 12016
295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015
296 (3) Section 58-17b-3095 is repealed July 1 2015
297 (4) Section 58-17b-3097 is repealed on July 12018
298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1
299 2018
300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1
301 2023
302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing
303 Act is repealed July 1 2019
304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1
305 2015
306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is
- 10shy
02-05-14 1 22 PM HB106
307 repealed July 12023
308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1
309 2014
310 [ttej] ill) Section 58-69-3025 is repealed on July 12015
311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017
Legislative Review Note as of 2-3-14 418 PM
Office of Legislative Research and General Counsel
- 11 shy
02-05-14 122 PM HBI06
59 (4) The division may further define or supplement the classifications of pharmacies
60 The division may impose restrictions upon classifications to protect the public health safety
61 and welfare
62 (5) Each pharmacy shall have a pharmacist-in-charge except as otherwise provided by
63 rule
64 (6) Whenever an applicable statute or rule requires or prohibits action by a pharmacy
65 the pharmacist-in-charge and the owner of the pharmacy shall be responsible for all activities
66 of the pharmacy regardless of the form of the business organization
67 Section 3 Section 58-17b-309 is amended to read
68 58-17b-309 Exemptions from licensure
69 (l) [For ptnp05C5 of] As used in this section
70 (a) Cosmetic drug
71 (i) means a prescription drug that is
72 (A) for the purpose of promoting attractiveness or altering the appearance of an
73 individual and
74 (8) listed as a cosmetic drug subject to the exemption under this section by the division
75 by administrative rule or has been expressly approved for online dispensing whether or not it is
76 dispensed online or through a physicians office and
77 (ii) does not include a prescription drug that is
78 (A) a controlled substance
79 (8) compounded by the physician or
80 (C) prescribed or used for the patient for the purpose of diagnosing curing or
81 preventing a disease
82 (b) Injectable weight loss drug
83 (i) means an injectable prescription drug
84 (A) prescribed to promote weight loss and
85 (8) listed as an injectable prescription drug subject to exemption under this section by
86 the division by administrative rule and
87 (ii) does not include a prescription drug that is a controlled substance
88 (c) Prescribing practitioner means an individual licensed under
89 (i) Chapter 31 b Nurse Practice Act as an advanced practice registered nurse with
- 3 shy
HB106 02-05-14 122 PM
90 prescriptive practice
91 (ii) Chapter 67 Utah Medical Practice Act
92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or
93 (iv) Chapter 70a Physician Assistant Act
94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l
95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the
96 acts or practices described in this section without being licensed under this chapter
97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the
98 individual notifies the division in writing of the individuals intent to dispense a drug under this
99 [snbsectioll] Subsection (2)
100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1
101 (c) an individual engaging in the practice of pharmacy technician under the direct
102 personal supervision of a pharmacist while making satisfactory progress in an approved
103 program as defined in division rule
104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an
105 injectable weight loss drug to the prescribing practitioners patient in accordance with
106 Subsection (4) or
107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists
108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic
109 drug to the optometrists patient in accordance with Subsection (4)
110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under
111 Subsection (2)( c) must take all examinations as required by division rule following completion
112 of an approved curriculum of education within the required time frame This exemption
113 expires immediately upon notification of a failing score of an examination and the individual
114 may not continue working as a pharmacy technician even under direct supervision
115 (4) A prescribing practitioner or optometrist is exempt from licensing under the
116 provisions of this part if the prescribing practitioner or optometrist
117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the
118 authority to dispense under Subsection (4)(b) and
119 (ii) informs the patient
120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing
-4shy
HB106 02-05-14 122 PM
152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the
153 prescribing practitioners or optometrists office and determine if the provisions of this section
154 are being met by the prescribing practitioner or optometrist
155 (d) If a prescribing practitioner or optometrist violates a provision of this section the
156 prescribing practitioner or optometrist may be subject to discipline under
157 (i) this chapter and
158 (ii) (A) Chapter 16a Utah Optometry Practice Act
159 (B) Chapter 31 b Nurse Practice Act
160 (C) Chapter 67 Utah Medical Practice Act
161 (D) Chapter 68 Utah Osteopathic Medical Practice Act
162 (E) Chapter 70a Physician Assistant Act or
163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act
164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the
165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah
166 Optometry Practice Act
167 Section 4 Section 58-17b-3095 is amended to read
168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy
169 Division study of dispensing practitioners
170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen
171 (a) means a prescription drug used to treat cancer manage its symptoms or provide
172 continuity of care for a cancer patient
173 (b) includes
174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal
175 methods and
176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize
177 physical and psychological symptoms or pain or to improve patient tolerance of cancer
178 treatments or prepare a patient for a subsequent course of therapy and
179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug
180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections
181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt
182 from licensure under this chapter
- 6shy
HB106 02-05-14 122 PM
214 (ii) is acting under the direction of a prescribing practitioner who is immediately
215 available on site for any necessary consultation and who has complied with Subsection
216 (2)(b)(i)
217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the
218 outpatient clinic setting and
219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)
220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to
221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section
222 (b) The evaluation under this Subsection (3) shall include
223 (i) practitioner compliance with the requirements of this section and Section
224 58-l7b-309
225 (ii) current research on dispensing and patient safety
226 (iii) survey of other state dispensing laws and
227 (iv) recommendations for future action concerning practitioner dispensing
228 (c) The division shall report to the Legislatures Health and Human Services Interim
229 Committee by November 302012 and by November 302013 with the results and
230 recommendations from the evaluation required by this Subsection (3)
231 (4) This section sunsets in accordance with Section 631-1-258
232 Section 5 Section 58-17b-3097 is enacted to read
233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an
234 employer sponsored clinic
235 (1) As used in this section
236 (a) Employer sponsored clinic means an entity that offers health care only to the
237 employees of an exclusive group of employers and the employees dependents
238 (b) Health care is as defined in Section 31 A-J-301
239 (c) Prepackaged drug means a prescription drug that
240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and
241 (ii) is packaged in a fixed quantity per package by
242 (A) the drug manufacturer
243 (B) a pharmaceutical wholesaler or distributor or
244 (C) a pharmacy licensed under this title
- 8 shy
~ -- -------------------
02-05-14 122 PM HB106
245 Cd) Prescribing practitioner is as defined in Section 58-17b-309
246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309
247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing
248 requirements of this chapter if the prescribing practitioner
249 Ca) treats an employee of one of an exclusive group of employers at an employer
250 sponsored clinic
251 Cb) prescribes a prepackaged drug to the employee
252 Cc) dispenses the prepackaged drug at the employer sponsored clinic
253 (d) notifies the division
254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the
255 employer sponsored clinic and
256 (ii) of the drug the prescribing practitioner intends to dispense
257 Ce) determines that providing the prepackaged drug to the employee at the employer
258 sponsored clinic is in the employees best interest
259 (f) informs the employee
260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner
261 from a pharmacy that is unaffiliated with the prescribing practitioner
262 (ii) of the directions for appropriate use of the prepackaged drug
263 (iii) of potential side effects to the use of the prepackaged drug and
264 (iv) how to contact the prescribing practitioner if the employee has questions or
265 concerns regarding the drug
266 (g) offers the employee the opportunity to consult with a pharmacist if the employee
267 asks for patient counseling and
268 (h) follows the administrative rules for a prescribing practitioner at an employer
269 sponsored clinic established by the division under Subsection (4)
270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a
271 prepackaged drug under this section requires physician supervision in its scope ofpractice
272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the
273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter
274 68 Utah Osteopathic Medical Practice Act
275 (4) The division shall in consultation with the board of pharmacy and the Physicians
- 9 shy
HBI06 02-05-14 122 PM
276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title
277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping
278 patient counseling purchasing and distribution operating treatment quality of care and
279 storage requirements for a prescribing practitioner at an employer sponsored clinic
280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a
281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing
282 practitioner is in compliance with this section
283 (6) If a prescribing practitioner violates a provision of this section the prescribing
284 practitioner may be subject to discipline under
285 (a) this chapter and
286 (b) any other chapter that governs the terms of the prescribing practitioners license
287 (7) The division shall evaluate the exemption created by this section and report to the
288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1
289 2018 on the results of the evaluation and the divisions recommendations regarding the
290 exemption
291 Section 6 Section 631-1-258 is amended to read
292 631-1-258 Repeal dates Title 58
293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is
294 repealed July 12016
295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015
296 (3) Section 58-17b-3095 is repealed July 1 2015
297 (4) Section 58-17b-3097 is repealed on July 12018
298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1
299 2018
300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1
301 2023
302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing
303 Act is repealed July 1 2019
304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1
305 2015
306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is
- 10shy
02-05-14 1 22 PM HB106
307 repealed July 12023
308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1
309 2014
310 [ttej] ill) Section 58-69-3025 is repealed on July 12015
311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017
Legislative Review Note as of 2-3-14 418 PM
Office of Legislative Research and General Counsel
- 11 shy
HB106 02-05-14 122 PM
90 prescriptive practice
91 (ii) Chapter 67 Utah Medical Practice Act
92 (iii) Chapter 68 Utah Osteopathic Medical Practice Act or
93 (iv) Chapter 70a Physician Assistant Act
94 (2) In addition to the exemptions from licensure in Sections 5R-1-307 [and]l
95 58-17b-3095 58-17b-3096 and 58-17b-3097 the following individuals may engage in the
96 acts or practices described in this section without being licensed under this chapter
97 (a) [if-the] an individual [is] described in Subsections (2)(b) (d) or (e) if the
98 individual notifies the division in writing of the individuals intent to dispense a drug under this
99 [snbsectioll] Subsection (2)
100 (b) a person selling or providing contact lenses in accordance with Section 5 8-16a-80 1
101 (c) an individual engaging in the practice of pharmacy technician under the direct
102 personal supervision of a pharmacist while making satisfactory progress in an approved
103 program as defined in division rule
104 (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an
105 injectable weight loss drug to the prescribing practitioners patient in accordance with
106 Subsection (4) or
107 (e) an optometrist as defined in Section 58-16a-l01 acting within the optometrists
108 scope of practice as defined in Section 58-16a-60 1 who prescribes and dispenses a cosmetic
109 drug to the optometrists patient in accordance with Subsection (4)
110 (3) In accordance with Subsection 58-t-303(1)(a) an individual exempt under
111 Subsection (2)( c) must take all examinations as required by division rule following completion
112 of an approved curriculum of education within the required time frame This exemption
113 expires immediately upon notification of a failing score of an examination and the individual
114 may not continue working as a pharmacy technician even under direct supervision
115 (4) A prescribing practitioner or optometrist is exempt from licensing under the
116 provisions of this part if the prescribing practitioner or optometrist
117 (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the
118 authority to dispense under Subsection (4)(b) and
119 (ii) informs the patient
120 (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing
-4shy
HB106 02-05-14 122 PM
152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the
153 prescribing practitioners or optometrists office and determine if the provisions of this section
154 are being met by the prescribing practitioner or optometrist
155 (d) If a prescribing practitioner or optometrist violates a provision of this section the
156 prescribing practitioner or optometrist may be subject to discipline under
157 (i) this chapter and
158 (ii) (A) Chapter 16a Utah Optometry Practice Act
159 (B) Chapter 31 b Nurse Practice Act
160 (C) Chapter 67 Utah Medical Practice Act
161 (D) Chapter 68 Utah Osteopathic Medical Practice Act
162 (E) Chapter 70a Physician Assistant Act or
163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act
164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the
165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah
166 Optometry Practice Act
167 Section 4 Section 58-17b-3095 is amended to read
168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy
169 Division study of dispensing practitioners
170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen
171 (a) means a prescription drug used to treat cancer manage its symptoms or provide
172 continuity of care for a cancer patient
173 (b) includes
174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal
175 methods and
176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize
177 physical and psychological symptoms or pain or to improve patient tolerance of cancer
178 treatments or prepare a patient for a subsequent course of therapy and
179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug
180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections
181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt
182 from licensure under this chapter
- 6shy
HB106 02-05-14 122 PM
214 (ii) is acting under the direction of a prescribing practitioner who is immediately
215 available on site for any necessary consultation and who has complied with Subsection
216 (2)(b)(i)
217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the
218 outpatient clinic setting and
219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)
220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to
221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section
222 (b) The evaluation under this Subsection (3) shall include
223 (i) practitioner compliance with the requirements of this section and Section
224 58-l7b-309
225 (ii) current research on dispensing and patient safety
226 (iii) survey of other state dispensing laws and
227 (iv) recommendations for future action concerning practitioner dispensing
228 (c) The division shall report to the Legislatures Health and Human Services Interim
229 Committee by November 302012 and by November 302013 with the results and
230 recommendations from the evaluation required by this Subsection (3)
231 (4) This section sunsets in accordance with Section 631-1-258
232 Section 5 Section 58-17b-3097 is enacted to read
233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an
234 employer sponsored clinic
235 (1) As used in this section
236 (a) Employer sponsored clinic means an entity that offers health care only to the
237 employees of an exclusive group of employers and the employees dependents
238 (b) Health care is as defined in Section 31 A-J-301
239 (c) Prepackaged drug means a prescription drug that
240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and
241 (ii) is packaged in a fixed quantity per package by
242 (A) the drug manufacturer
243 (B) a pharmaceutical wholesaler or distributor or
244 (C) a pharmacy licensed under this title
- 8 shy
~ -- -------------------
02-05-14 122 PM HB106
245 Cd) Prescribing practitioner is as defined in Section 58-17b-309
246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309
247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing
248 requirements of this chapter if the prescribing practitioner
249 Ca) treats an employee of one of an exclusive group of employers at an employer
250 sponsored clinic
251 Cb) prescribes a prepackaged drug to the employee
252 Cc) dispenses the prepackaged drug at the employer sponsored clinic
253 (d) notifies the division
254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the
255 employer sponsored clinic and
256 (ii) of the drug the prescribing practitioner intends to dispense
257 Ce) determines that providing the prepackaged drug to the employee at the employer
258 sponsored clinic is in the employees best interest
259 (f) informs the employee
260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner
261 from a pharmacy that is unaffiliated with the prescribing practitioner
262 (ii) of the directions for appropriate use of the prepackaged drug
263 (iii) of potential side effects to the use of the prepackaged drug and
264 (iv) how to contact the prescribing practitioner if the employee has questions or
265 concerns regarding the drug
266 (g) offers the employee the opportunity to consult with a pharmacist if the employee
267 asks for patient counseling and
268 (h) follows the administrative rules for a prescribing practitioner at an employer
269 sponsored clinic established by the division under Subsection (4)
270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a
271 prepackaged drug under this section requires physician supervision in its scope ofpractice
272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the
273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter
274 68 Utah Osteopathic Medical Practice Act
275 (4) The division shall in consultation with the board of pharmacy and the Physicians
- 9 shy
HBI06 02-05-14 122 PM
276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title
277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping
278 patient counseling purchasing and distribution operating treatment quality of care and
279 storage requirements for a prescribing practitioner at an employer sponsored clinic
280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a
281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing
282 practitioner is in compliance with this section
283 (6) If a prescribing practitioner violates a provision of this section the prescribing
284 practitioner may be subject to discipline under
285 (a) this chapter and
286 (b) any other chapter that governs the terms of the prescribing practitioners license
287 (7) The division shall evaluate the exemption created by this section and report to the
288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1
289 2018 on the results of the evaluation and the divisions recommendations regarding the
290 exemption
291 Section 6 Section 631-1-258 is amended to read
292 631-1-258 Repeal dates Title 58
293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is
294 repealed July 12016
295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015
296 (3) Section 58-17b-3095 is repealed July 1 2015
297 (4) Section 58-17b-3097 is repealed on July 12018
298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1
299 2018
300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1
301 2023
302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing
303 Act is repealed July 1 2019
304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1
305 2015
306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is
- 10shy
02-05-14 1 22 PM HB106
307 repealed July 12023
308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1
309 2014
310 [ttej] ill) Section 58-69-3025 is repealed on July 12015
311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017
Legislative Review Note as of 2-3-14 418 PM
Office of Legislative Research and General Counsel
- 11 shy
HB106 02-05-14 122 PM
152 prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the
153 prescribing practitioners or optometrists office and determine if the provisions of this section
154 are being met by the prescribing practitioner or optometrist
155 (d) If a prescribing practitioner or optometrist violates a provision of this section the
156 prescribing practitioner or optometrist may be subject to discipline under
157 (i) this chapter and
158 (ii) (A) Chapter 16a Utah Optometry Practice Act
159 (B) Chapter 31 b Nurse Practice Act
160 (C) Chapter 67 Utah Medical Practice Act
161 (D) Chapter 68 Utah Osteopathic Medical Practice Act
162 (E) Chapter 70a Physician Assistant Act or
163 (F) Chapter 83 Online Prescribing Dispensing and Facilitation Licensing Act
164 (6) Except as provided in Subsection (2)( e) this section does not restrict or limit the
165 scope of practice of an optometrist or optometric physician licensed under Chapter 16a Utah
166 Optometry Practice Act
167 Section 4 Section 58-17b-3095 is amended to read
168 58-17b-3095 Exemption for prescribing practitioner of cancer drug regimen -shy
169 Division study of dispensing practitioners
170 (1) [FOI pttlpOses of] As used in this section cancer drug treatment regimen
171 (a) means a prescription drug used to treat cancer manage its symptoms or provide
172 continuity of care for a cancer patient
173 (b) includes
174 (i) a chemotherapy drug administered intravenously orally rectally or by dermal
175 methods and
176 (ii) a drug used to support cancer treatment including to treat alleviate or minimize
177 physical and psychological symptoms or pain or to improve patient tolerance of cancer
178 treatments or prepare a patient for a subsequent course of therapy and
179 (c) does not mean a drug listed under federal1aw as a Schedule I II or rn drug
180 (2) In addition to the [exemption] exemptions from licensure under [Section] Sections
181 58-1-307 58-17b-309 58-17b-3096 and 58-17b-3097 the following individuals are exempt
182 from licensure under this chapter
- 6shy
HB106 02-05-14 122 PM
214 (ii) is acting under the direction of a prescribing practitioner who is immediately
215 available on site for any necessary consultation and who has complied with Subsection
216 (2)(b)(i)
217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the
218 outpatient clinic setting and
219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)
220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to
221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section
222 (b) The evaluation under this Subsection (3) shall include
223 (i) practitioner compliance with the requirements of this section and Section
224 58-l7b-309
225 (ii) current research on dispensing and patient safety
226 (iii) survey of other state dispensing laws and
227 (iv) recommendations for future action concerning practitioner dispensing
228 (c) The division shall report to the Legislatures Health and Human Services Interim
229 Committee by November 302012 and by November 302013 with the results and
230 recommendations from the evaluation required by this Subsection (3)
231 (4) This section sunsets in accordance with Section 631-1-258
232 Section 5 Section 58-17b-3097 is enacted to read
233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an
234 employer sponsored clinic
235 (1) As used in this section
236 (a) Employer sponsored clinic means an entity that offers health care only to the
237 employees of an exclusive group of employers and the employees dependents
238 (b) Health care is as defined in Section 31 A-J-301
239 (c) Prepackaged drug means a prescription drug that
240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and
241 (ii) is packaged in a fixed quantity per package by
242 (A) the drug manufacturer
243 (B) a pharmaceutical wholesaler or distributor or
244 (C) a pharmacy licensed under this title
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02-05-14 122 PM HB106
245 Cd) Prescribing practitioner is as defined in Section 58-17b-309
246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309
247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing
248 requirements of this chapter if the prescribing practitioner
249 Ca) treats an employee of one of an exclusive group of employers at an employer
250 sponsored clinic
251 Cb) prescribes a prepackaged drug to the employee
252 Cc) dispenses the prepackaged drug at the employer sponsored clinic
253 (d) notifies the division
254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the
255 employer sponsored clinic and
256 (ii) of the drug the prescribing practitioner intends to dispense
257 Ce) determines that providing the prepackaged drug to the employee at the employer
258 sponsored clinic is in the employees best interest
259 (f) informs the employee
260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner
261 from a pharmacy that is unaffiliated with the prescribing practitioner
262 (ii) of the directions for appropriate use of the prepackaged drug
263 (iii) of potential side effects to the use of the prepackaged drug and
264 (iv) how to contact the prescribing practitioner if the employee has questions or
265 concerns regarding the drug
266 (g) offers the employee the opportunity to consult with a pharmacist if the employee
267 asks for patient counseling and
268 (h) follows the administrative rules for a prescribing practitioner at an employer
269 sponsored clinic established by the division under Subsection (4)
270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a
271 prepackaged drug under this section requires physician supervision in its scope ofpractice
272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the
273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter
274 68 Utah Osteopathic Medical Practice Act
275 (4) The division shall in consultation with the board of pharmacy and the Physicians
- 9 shy
HBI06 02-05-14 122 PM
276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title
277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping
278 patient counseling purchasing and distribution operating treatment quality of care and
279 storage requirements for a prescribing practitioner at an employer sponsored clinic
280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a
281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing
282 practitioner is in compliance with this section
283 (6) If a prescribing practitioner violates a provision of this section the prescribing
284 practitioner may be subject to discipline under
285 (a) this chapter and
286 (b) any other chapter that governs the terms of the prescribing practitioners license
287 (7) The division shall evaluate the exemption created by this section and report to the
288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1
289 2018 on the results of the evaluation and the divisions recommendations regarding the
290 exemption
291 Section 6 Section 631-1-258 is amended to read
292 631-1-258 Repeal dates Title 58
293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is
294 repealed July 12016
295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015
296 (3) Section 58-17b-3095 is repealed July 1 2015
297 (4) Section 58-17b-3097 is repealed on July 12018
298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1
299 2018
300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1
301 2023
302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing
303 Act is repealed July 1 2019
304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1
305 2015
306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is
- 10shy
02-05-14 1 22 PM HB106
307 repealed July 12023
308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1
309 2014
310 [ttej] ill) Section 58-69-3025 is repealed on July 12015
311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017
Legislative Review Note as of 2-3-14 418 PM
Office of Legislative Research and General Counsel
- 11 shy
HB106 02-05-14 122 PM
214 (ii) is acting under the direction of a prescribing practitioner who is immediately
215 available on site for any necessary consultation and who has complied with Subsection
216 (2)(b)(i)
217 (iii) prepares or provides the cancer drug treatment regimen to the patient at the
218 outpatient clinic setting and
219 (iv) follows Subsections (2)(b )(iv) (v) and (viii)
220 (3) (a) The division shall work with stakeholders to evaluate the exemptions to
221 licensure under this title in Subsections 58-17b-309(2)(b) (d) and (e) and this section
222 (b) The evaluation under this Subsection (3) shall include
223 (i) practitioner compliance with the requirements of this section and Section
224 58-l7b-309
225 (ii) current research on dispensing and patient safety
226 (iii) survey of other state dispensing laws and
227 (iv) recommendations for future action concerning practitioner dispensing
228 (c) The division shall report to the Legislatures Health and Human Services Interim
229 Committee by November 302012 and by November 302013 with the results and
230 recommendations from the evaluation required by this Subsection (3)
231 (4) This section sunsets in accordance with Section 631-1-258
232 Section 5 Section 58-17b-3097 is enacted to read
233 58-17b-3097 Exemption for a practitioner prescribing prepackaged drugs at an
234 employer sponsored clinic
235 (1) As used in this section
236 (a) Employer sponsored clinic means an entity that offers health care only to the
237 employees of an exclusive group of employers and the employees dependents
238 (b) Health care is as defined in Section 31 A-J-301
239 (c) Prepackaged drug means a prescription drug that
240 (i) is not listed under federal or state law as a Schedule L II III IV or V drug and
241 (ii) is packaged in a fixed quantity per package by
242 (A) the drug manufacturer
243 (B) a pharmaceutical wholesaler or distributor or
244 (C) a pharmacy licensed under this title
- 8 shy
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02-05-14 122 PM HB106
245 Cd) Prescribing practitioner is as defined in Section 58-17b-309
246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309
247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing
248 requirements of this chapter if the prescribing practitioner
249 Ca) treats an employee of one of an exclusive group of employers at an employer
250 sponsored clinic
251 Cb) prescribes a prepackaged drug to the employee
252 Cc) dispenses the prepackaged drug at the employer sponsored clinic
253 (d) notifies the division
254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the
255 employer sponsored clinic and
256 (ii) of the drug the prescribing practitioner intends to dispense
257 Ce) determines that providing the prepackaged drug to the employee at the employer
258 sponsored clinic is in the employees best interest
259 (f) informs the employee
260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner
261 from a pharmacy that is unaffiliated with the prescribing practitioner
262 (ii) of the directions for appropriate use of the prepackaged drug
263 (iii) of potential side effects to the use of the prepackaged drug and
264 (iv) how to contact the prescribing practitioner if the employee has questions or
265 concerns regarding the drug
266 (g) offers the employee the opportunity to consult with a pharmacist if the employee
267 asks for patient counseling and
268 (h) follows the administrative rules for a prescribing practitioner at an employer
269 sponsored clinic established by the division under Subsection (4)
270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a
271 prepackaged drug under this section requires physician supervision in its scope ofpractice
272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the
273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter
274 68 Utah Osteopathic Medical Practice Act
275 (4) The division shall in consultation with the board of pharmacy and the Physicians
- 9 shy
HBI06 02-05-14 122 PM
276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title
277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping
278 patient counseling purchasing and distribution operating treatment quality of care and
279 storage requirements for a prescribing practitioner at an employer sponsored clinic
280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a
281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing
282 practitioner is in compliance with this section
283 (6) If a prescribing practitioner violates a provision of this section the prescribing
284 practitioner may be subject to discipline under
285 (a) this chapter and
286 (b) any other chapter that governs the terms of the prescribing practitioners license
287 (7) The division shall evaluate the exemption created by this section and report to the
288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1
289 2018 on the results of the evaluation and the divisions recommendations regarding the
290 exemption
291 Section 6 Section 631-1-258 is amended to read
292 631-1-258 Repeal dates Title 58
293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is
294 repealed July 12016
295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015
296 (3) Section 58-17b-3095 is repealed July 1 2015
297 (4) Section 58-17b-3097 is repealed on July 12018
298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1
299 2018
300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1
301 2023
302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing
303 Act is repealed July 1 2019
304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1
305 2015
306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is
- 10shy
02-05-14 1 22 PM HB106
307 repealed July 12023
308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1
309 2014
310 [ttej] ill) Section 58-69-3025 is repealed on July 12015
311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017
Legislative Review Note as of 2-3-14 418 PM
Office of Legislative Research and General Counsel
- 11 shy
~ -- -------------------
02-05-14 122 PM HB106
245 Cd) Prescribing practitioner is as defined in Section 58-17b-309
246 (2) In addition to the exemptions described in Sections 58-1-307 58-17b-309
247 58-17b-3095 and 58-17b-3096 a prescribing practitioner is exempt from the licensing
248 requirements of this chapter if the prescribing practitioner
249 Ca) treats an employee of one of an exclusive group of employers at an employer
250 sponsored clinic
251 Cb) prescribes a prepackaged drug to the employee
252 Cc) dispenses the prepackaged drug at the employer sponsored clinic
253 (d) notifies the division
254 (i) that the prescribing practitioner intends to dispense the prepackaged drug at the
255 employer sponsored clinic and
256 (ii) of the drug the prescribing practitioner intends to dispense
257 Ce) determines that providing the prepackaged drug to the employee at the employer
258 sponsored clinic is in the employees best interest
259 (f) informs the employee
260 (i) that the employee may obtain the drug prescribed by the prescribing practitioner
261 from a pharmacy that is unaffiliated with the prescribing practitioner
262 (ii) of the directions for appropriate use of the prepackaged drug
263 (iii) of potential side effects to the use of the prepackaged drug and
264 (iv) how to contact the prescribing practitioner if the employee has questions or
265 concerns regarding the drug
266 (g) offers the employee the opportunity to consult with a pharmacist if the employee
267 asks for patient counseling and
268 (h) follows the administrative rules for a prescribing practitioner at an employer
269 sponsored clinic established by the division under Subsection (4)
270 (3) If the chapter that governs the license of a prescribing practitioner dispensing a
271 prepackaged drug under this section requires physician supervision in its scope ofpractice
272 requirements the prescribing practitioner shall only dispense a prepackaged drug under the
273 supervision of an individual licensed under Chapter 67 Utah Medical Practice Act or Chapter
274 68 Utah Osteopathic Medical Practice Act
275 (4) The division shall in consultation with the board of pharmacy and the Physicians
- 9 shy
HBI06 02-05-14 122 PM
276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title
277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping
278 patient counseling purchasing and distribution operating treatment quality of care and
279 storage requirements for a prescribing practitioner at an employer sponsored clinic
280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a
281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing
282 practitioner is in compliance with this section
283 (6) If a prescribing practitioner violates a provision of this section the prescribing
284 practitioner may be subject to discipline under
285 (a) this chapter and
286 (b) any other chapter that governs the terms of the prescribing practitioners license
287 (7) The division shall evaluate the exemption created by this section and report to the
288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1
289 2018 on the results of the evaluation and the divisions recommendations regarding the
290 exemption
291 Section 6 Section 631-1-258 is amended to read
292 631-1-258 Repeal dates Title 58
293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is
294 repealed July 12016
295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015
296 (3) Section 58-17b-3095 is repealed July 1 2015
297 (4) Section 58-17b-3097 is repealed on July 12018
298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1
299 2018
300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1
301 2023
302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing
303 Act is repealed July 1 2019
304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1
305 2015
306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is
- 10shy
02-05-14 1 22 PM HB106
307 repealed July 12023
308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1
309 2014
310 [ttej] ill) Section 58-69-3025 is repealed on July 12015
311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017
Legislative Review Note as of 2-3-14 418 PM
Office of Legislative Research and General Counsel
- 11 shy
HBI06 02-05-14 122 PM
276 Licensing Board created in Section 58-67-201 adopt administrative rules pursuant to Title
277 63G Chapter 3 Utah Administrative Rulemaking Act that establish labeling record keeping
278 patient counseling purchasing and distribution operating treatment quality of care and
279 storage requirements for a prescribing practitioner at an employer sponsored clinic
280 (5) The division may inspect the office of a prescribing practitioner who is dispensing a
281 prepackaged drug at an employer sponsored clinic to determine whether the prescribing
282 practitioner is in compliance with this section
283 (6) If a prescribing practitioner violates a provision of this section the prescribing
284 practitioner may be subject to discipline under
285 (a) this chapter and
286 (b) any other chapter that governs the terms of the prescribing practitioners license
287 (7) The division shall evaluate the exemption created by this section and report to the
288 Legislatures Health and Human Services Interim Committee by July 1 2016 and by July 1
289 2018 on the results of the evaluation and the divisions recommendations regarding the
290 exemption
291 Section 6 Section 631-1-258 is amended to read
292 631-1-258 Repeal dates Title 58
293 (1) Title 58 Chapter 13 Health Care Providers Immunity from Liability Act is
294 repealed July 12016
295 (2) Title 58 Chapter 15 Health Facility Administrator Act is repealed July 12015
296 (3) Section 58-17b-3095 is repealed July 1 2015
297 (4) Section 58-17b-3097 is repealed on July 12018
298 [t47] ill Title 58 Chapter 20a Environmental Health Scientist Act is repealed July 1
299 2018
300 [t5] ill Title 58 Chapter 40 Recreational Therapy Practice Act is repealed July 1
301 2023
302 [f67] ill Title 58 Chapter 41 Speech-language Pathology and Audiology Licensing
303 Act is repealed July 1 2019
304 [ffl] ill Title 58 Chapter 42a Occupational Therapy Practice Act is repealed July 1
305 2015
306 [f87] m Title 58 Chapter 46a Hearing Instrument Specialist Licensing Act is
- 10shy
02-05-14 1 22 PM HB106
307 repealed July 12023
308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1
309 2014
310 [ttej] ill) Section 58-69-3025 is repealed on July 12015
311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017
Legislative Review Note as of 2-3-14 418 PM
Office of Legislative Research and General Counsel
- 11 shy
02-05-14 1 22 PM HB106
307 repealed July 12023
308 [t9J] QQl Title 58 Chapter 47b Massage Therapy Practice Act is repealed July 1
309 2014
310 [ttej] ill) Section 58-69-3025 is repealed on July 12015
311 [tttJ] flll Title 58 Chapter 72 Acupuncture Licensing Act is repealed July 12017
Legislative Review Note as of 2-3-14 418 PM
Office of Legislative Research and General Counsel
- 11 shy