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CODE OF STATE REGULATIONS 1JOHN R. ASHCROFT (1/29/19)Secretary of State

Rules ofDepartment of Insurance,Financial Institutions andProfessional Registration

Division 2220—State Board of PharmacyChapter 2—General Rules

Title Page

20 CSR 2220-2.005 Definitions ...................................................................................3

20 CSR 2220-2.010 Pharmacy Standards of Operation .......................................................3

20 CSR 2220-2.013 Prescription Delivery Requirements.....................................................6

20 CSR 2220-2.015 Termination of Business as a Pharmacy ................................................6

20 CSR 2220-2.016 Pharmacy Operating Procedures During Declared Disasters........................7

20 CSR 2220-2.017 Non-Electronic (Manual) Prescription Records .......................................7

20 CSR 2220-2.018 Prescription Requirements ................................................................8

20 CSR 2220-2.020 Pharmacy Permits ..........................................................................8

20 CSR 2220-2.025 Nonresident Pharmacies .................................................................10

20 CSR 2220-2.030 Educational and Licensing Requirements (Rescinded August 30, 2013) ........10

20 CSR 2220-2.032 Licensure by Examination for Graduates of Nonapproved Foreign Pharmacy Schools (Rescinded August 30, 2013) ...................................10

20 CSR 2220-2.034 Licensure by Reciprocity for Graduates of Nonapproved Foreign Pharmacy Schools Who Have Been Licensed in Another State (Rescinded August 30, 2013) ..........................................................10

20 CSR 2220-2.036 Temporary License (Rescinded August 30, 2013)...................................11

20 CSR 2220-2.050 Public Complaint Handling and Disposition Procedure ............................11

20 CSR 2220-2.060 Gold Certificates ..........................................................................11

20 CSR 2220-2.080 Electronic Prescription Records ........................................................12

20 CSR 2220-2.083 Electronic Record-Keeping Systems ...................................................13

2 CODE OF STATE REGULATIONS (1/29/19) JOHN R. ASHCROFT

Secretary of State

20 CSR 2220-2.085 Electronic Prescriptions and Medication Orders ....................................13

20 CSR 2220-2.090 Pharmacist-in-Charge.....................................................................13

20 CSR 2220-2.095 Collection of Medication for Destruction.............................................14

20 CSR 2220-2.100 Continuing Pharmacy Education (Rescinded August 30, 2013)...................16

20 CSR 2220-2.110 PRN Refills ................................................................................16

20 CSR 2220-2.120 Transfer of Prescription Information for the Purpose of Refill ...................17

20 CSR 2220-2.130 Drug Repackaging ........................................................................17

20 CSR 2220-2.140 Prescription Services by Pharmacists/Pharmacies for Residents in Long-Term Care Facilities..............................................................18

20 CSR 2220-2.145 Minimum Standards for Multi-Med Dispensing .....................................19

20 CSR 2220-2.150 Mandatory Reporting Rule ..............................................................20

20 CSR 2220-2.160 Definition of Disciplinary Actions .....................................................20

20 CSR 2220-2.165 Licensure Disciplinary Agreements....................................................21

20 CSR 2220-2.170 Procedure for Impaired Pharmacist ....................................................21

20 CSR 2220-2.175 Well-Being Program ......................................................................22

20 CSR 2220-2.180 Public Records.............................................................................24

20 CSR 2220-2.190 Patient Counseling ........................................................................25

20 CSR 2220-2.200 Sterile Compounding .....................................................................25

20 CSR 2220-2.300 Record Confidentiality and Disclosure ................................................32

20 CSR 2220-2.400 Compounding Standards of Practice ...................................................32

20 CSR 2220-2.450 Fingerprint Requirements (Rescinded August 30, 2013) ...........................34

20 CSR 2220-2.500 Nuclear Pharmacy—Minimum Standards for Operation ...........................34

20 CSR 2220-2.600 Standards of Operation for a Class F: Renal Dialysis Pharmacy .................36

20 CSR 2220-2.650 Standards of Operation for a Class J: Shared Services Pharmacy................36

20 CSR 2220-2.675 Standards of Operation/Licensure for Class L Veterinary Pharmacies ..........37

20 CSR 2220-2.700 Pharmacy Technician Registration .....................................................39

20 CSR 2220-2.800 Vacuum Tube Drug Delivery System..................................................40

20 CSR 2220-2.900 Automated Dispensing and Storage Systems .........................................40

20 CSR 2220-2.950 Automated Filling Systems ..............................................................42

Title 20—DEPARTMENT OFINSURANCE, FINANCIAL

INSTITUTIONS ANDPROFESSIONAL REGISTRATIONDivision 2220—State Board of Pharmacy

Chapter 2—General Rules

20 CSR 2220-2.005 Definitions

PURPOSE: This rule defines the term “drug”as utilized in Chapter 338, RSMo, and therules of the board.

(1) “Drug,” “prescription drug,” or “legenddrug” means any drug or biological prod-uct—

(A) Subject to section 503(b) of the FederalFood, Drug and Cosmetic Act, including fin-ished dosage forms and active ingredientssubject to section 503(b);

(B) Required by federal law to be labeledwith one (1) of the following statements,prior to being dispensed or delivered:

1. “Caution: Federal law prohibits dis-pensing without prescription”;

2. “Caution: Federal law restricts thisdrug to use by or on the order of a licensedveterinarian”; or

3. “Rx Only”; and(C) Required by any applicable federal or

state law or regulation to be dispensed by pre-scription only or that is restricted to use bypractitioners only.

(2) For purposes of sections 338.300 to338.370, RSMo, the term “drug,” “prescrip-tion drug,” or “legend drug” shall notinclude:

(A) An investigational new drug or biolog-ical product, as defined by 21 CFR 312.3(b),that is being utilized for the purposes of con-ducting a clinical trial/investigation of thatdrug or product if such clinical trial/investi-gation is governed by, and being conductedpursuant to, 21 CFR 312, et seq.;

(B) A legend drug or biological productbeing utilized for the purposes of a clinicaltrial/investigation that is governed by, andbeing conducted pursuant to, 21 CFR 312, etseq.; or

(C) A legend drug or biological productbeing utilized for the purposes of a clinicaltrial/investigation that is governed orapproved by an institutional review boardsubject to 21 CFR 56 or 45 CFR Part 46.

AUTHORITY: section 338.010, RSMo Supp.2010 and sections 338.140, 338.280, and338.350, RSMo 2000.* Emergency rule filedSept. 3, 2010, effective Sept. 13, 2010,expired March 11, 2011. Original rule filedMarch 7, 2011, effective Aug. 30, 2011.

*Original authority: 338.010, RSMo 1939, amended 1951,

1989, 1990, 2007, 2009; 338.140, RSMo 1939, amended1981, 1989, 1997; 338.280, RSMo 1951, amended 1971,1981; and 338.350, RSMo 1989, amended 1993, 1995.

20 CSR 2220-2.010 Pharmacy Standards ofOperation

PURPOSE: This rule defines terms used inthe regulations of the State Board of Pharma-cy and outlines the conditions necessary forthe operation of a pharmacy.

(1) The word medicine or medicines is aword similar or of like import to the wordspharmacist, pharmacy, apothecary shop,chemist shop, drug store, druggist and drugs,and no person shall carry on, conduct ortransact a business under a name which con-tains, as part of the name, the word medicineor medicines, unless the place of business issupervised by a licensed pharmacist.

(A) At all times when prescriptions arecompounded in a pharmacy or other estab-lishments holding a Missouri pharmacy per-mit, there shall be on duty and present in thatplace of business a pharmacist licensed inMissouri as provided by law. In any Class J:Shared Service pharmacy where a permit ismaintained at a location for the purpose ofremote dispensing as defined in 20 CSR2220-2.900 the pharmacist may be consid-ered on duty and present as long as allrequired electronic connection requirementsare maintained and the pharmacist is accessi-ble at all times to respond to patient’s orother health professionals’ inquiries orrequests pertaining to drugs dispensedthrough the use of the automated pharmacysystem. When there is no pharmacist on duty,no prescription will be compounded, dis-pensed or otherwise provided and the publicwill be advised that no pharmacist is on dutyby means of signs stating this fact. The signswill be displayed prominently on the doors ofall entrances and the prescription counter ofthe pharmacy and the signs will be composedof letters of a minimum height of two inches(2").

(B) Whenever, in a pharmacy or otherestablishment holding a Missouri pharmacypermit, a person other than a licensed phar-macist does compound, dispense or in anyway provide any drug, medicine or poisonpursuant to a lawful prescription, a licensedpharmacist must be physically present withinthe confines of the dispensing area, able torender immediate assistance and able todetermine and correct any errors in the com-pounding, preparation or labeling of thatdrug, medicine or poison before the drug,medicine or poison is dispensed or sold. Inany Class J: Shared Service pharmacy wherea permit is maintained at a location for thepurpose of remote dispensing as defined in 20

CSR 2220-2.900 the pharmacist may be con-sidered on duty and present as long as allrequired electronic connection requirementsare maintained and the pharmacist is accessi-ble at all times to respond to patient’s orother health professionals’ inquiries orrequests pertaining to drugs dispensedthrough the use of the automated pharmacysystem. The pharmacist personally shallinspect and verify the accuracy of the con-tents of, and the label after it is affixed to,any prescribed drug, medicine or poisoncompounded or dispensed by a person otherthan a licensed pharmacist.

(C) No pharmacy shall be licensed underthe provisions of this chapter unless it isequipped with proper pharmaceutical equip-ment and reference manuals. Requirementsfor proper equipment and references mayvary between pharmacies and must insureaccuracy and safety of all pharmaceuticalactivity.

1. Basic equipment recognized by thelatest edition of the United States Pharma-copoeia (USP), the United States Pharma-copoeia/Drug Information (USP/DI) or Rem-ington’s Pharmaceutical Sciences shall beavailable for any procedures utilized in thedispensing, compounding or admixture ofdrugs and drug-related devices, and mustmaintain conformance with these publica-tions.

2. A suitable machine or electronic datadevice for the numbering of all prescriptionsmust be maintained along with appropriateprinting equipment for the production of pre-scription drug labels.

(D) Reference manuals may include anygenerally recognized pharmaceutical publica-tion other than periodicals or journals. Apharmacy must maintain, at a minimum, thecurrent or latest edition of a reference manu-al(s) which includes all Federal Drug Admin-istration (FDA)-approved drugs. The follow-ing topics must be included in thereference(s) selected:

1. Pharmacology of drugs; 2. Dosages and clinical effects of drugs;

and 3. Patient information.

(E) Pharmacies shall maintain at least one(1) current edition of statutes and rules gov-erning the pharmacy’s practice.

(F) All pharmacies shall be maintained ina clean and sanitary condition at all times.Any procedures used in the dispensing, com-pounding and admixture of drugs or drug-related devices must be completed underclean and, when recommended, aseptic con-ditions.

1. Appropriate sewage disposal and ahot and cold water supply within the pharma-cy must be available.

CODE OF STATE REGULATIONS 3ROBIN CARNAHAN (7/31/11)Secretary of State

Chapter 2—General Rules 20 CSR 2220-2

2. Appropriate housekeeping and sanita-tion of all areas where drugs are stored ordispensed must be maintained.

3. Animals, except for service animalsas defined by the Americans with DisabilitiesAct (ADA), are not allowed in pharmacies.

(G) The temperature of the facility wheredrugs are stored must be maintained thermo-statically within temperature requirements asprovided for by the manufacturer or the latestedition of the USP. Adequate refrigerationmust be available to insure enough storagespace for drugs requiring refrigeration orfreezing and under temperatures adequate tomaintain the drug products as recommendedby the manufacturer, the latest edition of theUSP, or both. Drugs and drug-related devicesmust be stored separately from food andother items.

(H) Pharmacies must maintain adequatesecurity in order to deter theft of drugs bypersonnel or the public. Sufficient alarm sys-tems or locking mechanisms must be in placeif the pharmacy is located in a facility intowhich the public has access and the pharma-cy’s hours of operation are different fromthose of the remainder of the facility.

(I) Pharmacies which maintain storagesites or warehouse facilities for the storage ofpharmaceuticals at a separate address orpremises from the main pharmacy that holdsa pharmacy permit shall register those sites asstorage facilities of the licensed pharmacy.Information required for proper registrationof a storage facility shall include the addressof the facility, hours of operation (if applica-ble), pharmacy permit numbers of the phar-macies that it services, and a certified state-ment that the facility is used for the solepurpose of distributing drugs only within itsown pharmacy operations.

1. Records must be maintained at thesefacilities to guarantee security, storage andaccountability of all drugs and drug-relateddevices under proper conditions.

2. All storage and warehouse locationswill be considered facilities of a pharmacypursuant to section 338.240, RSMo and shallbe subject to inspection by the board asdefined in section 338.150, RSMo.

3. No fee will be charged by the boardfor registering a facility as defined in subsec-tion (1)(I) of this rule.

(J) Pharmacies that maintain storage sitesor warehouse facilities for the storage of con-fidential pharmacy records at a separateaddress or premises from the main pharmacythat holds a pharmacy permit shall registerthose sites as storage facilities of the licensedpharmacy. Information required for properregistration of a storage facility shall includethe address of the facility, hours of operation

(if applicable), pharmacy permit numbers ofthe pharmacies that it services, and a state-ment that the facility is used for the sole pur-pose of storing records within its own phar-macy operations.

1. All storage and warehouse locationsmust maintain adequate security including analarm system. Any breach in security mustbe documented and reported in writing viafacsimile, email communication, or letter tothe board within fifteen (15) days of thebreach of confidentiality.

2. All storage and warehouse locationswill be considered facilities of a pharmacypursuant to section 338.240, RSMo and shallbe subject to inspection by the board asdefined in section 338.150, RSMo.

3. No fee will be charged by the boardfor registering a facility as defined in subsec-tion (1)(J) of this rule.

4. All storage and warehouse locationsmust comply with 19 CSR 30-1.

5. No records less than two (2) years oldmay be stored offsite.

6. All storage and warehouse locationsstoring confidential pharmacy records mustmake records retrievable within two (2) busi-ness days when requested by the board or itsrepresentatives.

(K) All pharmacists will be required tohave a photo of themselves not smaller thantwo inches by two inches (2" × 2") in theupper right-hand corner of the current renew-al licenses. This photo and license renewalshall be conspicuously exposed in the phar-macy or drug store or place of business inwhich the pharmacist is employed as requiredby law.

(L) Pharmacists regularly working as reliefpersons for more than one (1) store shall havein their possession proper identification oftheir pharmacy licensure.

(M) Pharmacy operations must be conduct-ed at all times under the supervision of aproperly designated pharmacist-in-charge.When a licensed pharmacist leaves theemployment of a pharmacy where s/he hasbeen pharmacist-in-charge, s/he immediatelyshall notify the executive director of theboard of the termination of his/her services inthe pharmacy. Likewise, the holder of thepermit shall notify the executive director ofthe board of the termination of the servicesand give the name of the new licensed phar-macist-in-charge.

(N) Pharmacists are responsible to informthe executive director of the board in the caseof changed address. Any mail or communica-tions returned to the executive director’soffice marked Unknown, Incorrect Address,and the like, will not be sent out a secondtime until the correct address is sent in.

(O) When a pharmacy permit holder knowsor should have known, within the usual andcustomary standards of conduct governing theoperation of a pharmacy as defined in Chap-ter 338, RSMo, that an employee, licensed orunlicensed, has violated the pharmacy laws orrules, the permit holder shall be subject todiscipline under Chapter 338, RSMo.

(P) When required by section 338.013(10),RSMo, to report technician disciplinaryaction, the pharmacy must notify the board inwriting within fifteen (15) days of the action.The notification must include:

1. The name and permit number ofpharmacy;

2. Name of person making the notifica-tion;

3. Name of technician;4. Technician registration number;5. Date of action; and6. Reason for action.

(Q) Pharmacists must inform the executivedirector of the board of any change in theiremployment address. The notification of anemployment change must be provided in writ-ing to the board no later than fifteen (15) daysfollowing any effective change.

(2) Every pharmacy shall designate as its pri-mary means of record keeping either a man-ual system which provides for the consecutivenumbering of hard copy prescriptions andcomplies with the provisions of section (3) ofthis rule or an electronic system which com-plies with the provisions of 20 CSR 2220-2.080. The designated record system shall beused to record the pharmacy’s dispensing ofall drugs, medicines and poisons.

(3) A pharmacy using a record keeping sys-tem other than an electronic system meetingthe requirements of 20 CSR 2220-2.080 torecord its dispensing of drugs, medicines andpoisons shall provide a method of recordingall of the following information concerningthe refill of any prescription medication onthe back or reverse side of every prescriptionorder:

(A) The date the drug, medicine or poisonwas dispensed;

(B) The dispensing pharmacist’s initials;and

(C) The amount of drug, medicine or poi-son dispensed to the patient if different fromthe amount on the face of the prescriptionorder.

(4) Each licensed pharmacy shall maintain atleast three (3) separate files of prescriptionsand they shall be as follows:

4 CODE OF STATE REGULATIONS (7/31/11) ROBIN CARNAHAN

Secretary of State

20 CSR 2220-2—DEPARTMENT OF INSURANCE,FINANCIAL INSTITUTIONS ANDPROFESSIONAL REGISTRATION Division 2220—State Board of Pharmacy

(A) All prescriptions for controlled drugslisted in Schedules I and II shall be main-tained in a separate prescription file;

(B) All prescriptions for controlled drugslisted in Schedules III, IV and V shall bemaintained in a separate prescription file; and

(C) All other prescriptions for noncon-trolled drugs shall be maintained in a separateprescription file(s).

(5) Pharmacies shall establish and maintaininventories and records of all transactionsregarding the receipt and distribution or otherdisposition of legend drugs. Said recordsshall be maintained for two (2) years and bereadily retrievable upon request by the boardor its representatives.

(6) Drugs and devices that are maintained aspart of the pharmacy inventory or are beingprocessed for dispensing or other distributionpurposes must be physically separated at alltimes from articles, supplies or other drugsthat are for employee personal use or that areoutdated, distressed, misbranded or adulter-ated. An area separate from drug storagemust be used to store quarantined, nonusablesubstances. Areas used for this type of drugstorage must be clearly identified. Any pre-scription drugs that are present in a licensedpharmacy but are for the personal use ofpharmacy personnel must be labeled in accor-dance with section 338.059, RSMo.

(7) All records required by Chapters 195 and338, RSMo or divisions 20 CSR 2220 and 19CSR 30 shall be available for photocopyingor electronic duplication by a board of phar-macy representative.

(8) Except as provided for in section 21 U.S.C.section 353(d)(1)(A)–(C), (d)(2)(A)(i)–(ii),(d)(2)(B)(i)–(iv), and (d)(3)(A)(i)–(ii) of theFederal Food, Drug and Cosmetic Act, drugsamples shall not be maintained in pharma-cies.

(9) A home health or hospice agency licensedor certified according to Chapter 197,RSMo, or any licensed nurses of such agency,may possess drugs in the usual course ofbusiness of such agency without beinglicensed as a pharmacist or a pharmacy.

(A) The list of drugs that may be possessedby a home health or hospice agency without alicense or permit, as defined in section (9), isas follows:

1. Injectable dosage forms of sodiumchloride and water;

2. Irrigation dosage forms of sodiumchloride and water that carry a federal pre-scription only restriction;

3. Injectable dosage forms of heparinand alteplase in concentrations that are indi-cated for maintenance of venous accessdevices;

4. Injectable dosage forms of diphenhy-dramine and epinephrine;

5. Vaccines indicated for public healthneeds, such as influenza, pneumonia, hepati-tis A and hepatitis B; and

6. Tuberculin test material.(B) The agency shall have a policy and pro-

cedure that addresses at least the following:1. Specific drugs authorized to be pos-

sessed by the agency and the nurse;2. Indications for use of the drugs pos-

sessed;3. Receiving physicians’ orders for

administration of the drugs;4. Leaving drugs with the patient for

routine care procedures;5. Conditions for storage and transport

of the drugs by the agency and the nurse; and6. Quantity of drugs possessed by the

agency and the nurse.(C) The nurse must have a physician’s

authorization, such as an individual patientorder, protocol or standing order, to adminis-ter the drugs.

(D) When the patient or the patient’s rep-resentative has been instructed, verbally andin writing, in the performance of routine careprocedures, up to a two (2)-week supply ofsodium chloride, water, and heparin may beleft with the patient for these procedures.Drugs left with the patient shall be labeledwith instructions for use. A record shall bemade of all drugs left with the patient in thepatient’s medical record. Drugs left with thepatient may not be returned to the agency.

(E) Drugs may be stored at the agency ortransported by the nurse, and shall be storedor transported at all times in accordance withthe manufacturer’s storage requirements.Refrigerator units used by the agency for stor-ing drugs shall not be used for storing non-drug items.

(F) All drugs must be received from alicensed pharmacy or drug distributor. Thequantity of drugs possessed by an agencyshall be limited to that necessary to meet theneeds of the agency’s patient population fortwo (2) weeks.

(10) Class I: Consultant Pharmacies asdefined in 20 CSR 2220-2.020(9)(I) andapproved by the board to be located within aresidence shall be required to address andcomply with the following minimum stan-dards of practice:

(A) Location Requirements—1. The pharmacy must be located in a

separate room that provides for a door with

suitable lock;2. Sufficient storage for securing confi-

dential documents and any hardware used inaccessing a central pharmacy by electronicconnection must be provided;

3. Ceiling and walls must be constructedof plaster, drywall, brick or other substantialsubstance that affords a design that makes theroom separate and distinct from the remain-der of the domicile. Drop down ceilings thatallow access into the room are not allowed;

4. All locations must be inspected andhave approval by the board prior to the initi-ation of services; and

5. Patients are not allowed in the phar-macy.

(B) Documentation—1. Maintain a current policy and proce-

dure manual that is attested by the signatureand date of review of the pharmacist-in-charge to its accuracy. All pharmacists work-ing at the pharmacy shall be required to signthe manual attesting to their review andunderstanding of all policies and proceduresin force;

2. Maintain documentation that the per-mit holder has provided training to all person-nel on all operations associated with the phar-macy;

3. The permit holder must complete anaudit to ensure compliance with pharmacypolicy and procedures and this regulation at aminimum of twice per year, through physicalvisits by representatives of the permit holder.Audit results must be maintained by the per-mit holder for a period of three (3) years; and

4. If the pharmacist is working under acontract for the permit holder, a copy of thecontract shall be available during an inspec-tion.

(C) Security—Records and Internet—1. All electronic data processing systems

must meet all applicable state and federalconfidentiality laws and regulations;

2. Data processing systems must utilizesufficient security software;

3. Any breach in the security of the sys-tem must be documented and reported to theboard of pharmacy within seven (7) days ofthe breach of confidentiality. Such documen-tation shall be available during an inspection.

(D) Licensure and Inspection—1. Each location must maintain and dis-

play a current Class I permit. The permitholder for this permit must be the pharmacythe individual pharmacist is employed by orcontracted with;

2. Routine inspections for in-state phar-macies shall be arranged ahead of time. Noti-fication by the inspector to the permit holderwill be provided a minimum of seventy-two

CODE OF STATE REGULATIONS 5ROBIN CARNAHAN (10/31/12)Secretary of State


(72) hours ahead of the scheduled inspection.The permit holder must arrange for a desig-nated representative to be present that is nota resident of the location under inspection;

3. A pharmacy located outside the statemust maintain a pharmacist-in-charge with acurrent and active pharmacist license with thestate of Missouri;

4. The audits required in paragraph(10)(B)3. shall be available for review duringthe inspection; and

5. The pharmacy shall provide copies ofinspections completed by the state in whichthey are located if such inspections arerequired within seven (7) business days of theinspection date.

AUTHORITY: sections 338.140, 338.240,and 338.280, RSMo 2000 and sections338.010 and 338.210, RSMo Supp. 2007.*This rule originally filed as 4 CSR 220-2.010.Original rule filed July 18, 1962, effectiveJuly 28, 1962. Amended: Filed Nov. 9, 1966,effective Nov. 19, 1966. Amended: Filed Oct.27, 1970, effective Nov. 6, 1970. Amended:Filed Dec. 31, 1975, effective Jan. 10, 1976.Amended: Filed May 21, 1979, effective Nov.12, 1979. Amended: Filed April 14, 1982,effective July 11, 1982. Amended: Filed April16, 1985, effective Sept. 27, 1985. Amended:Filed Nov. 4, 1985, effective March 13, 1986.Amended: Filed Dec. 15, 1987, effectiveApril 28, 1988. Amended: Filed Oct. 12,1988, effective March 11, 1989. Amended:Filed Jan. 30, 1991, effective July 8, 1991.Amended: Filed Jan. 27, 1995, effective Sept.30, 1995. Amended: Filed June 29, 1999,effective Jan. 30, 2000. Amended: FiledMarch 15, 2000, effective Sept. 30, 2000.Amended: Filed July 24, 2001, effective Feb.28, 2002. Amended: Filed Feb. 18, 2003,effective Sept. 30, 2003. Amended: Filed May13, 2005, effective Oct. 30, 2005. Moved to20 CSR 2220-2.010, effective Aug. 28, 2006.Amended: Filed Aug. 21, 2006, effectiveApril 30, 2007. Amended: Filed Feb. 6, 2008,effective Aug. 30, 2008.

*Original authority: 338.010, RSMo 1939, amended 1951,1989, 1990, 2007; 338.140, RSMo 1939, amended 1981,1989, 1997; 338.210, RSMo 1951, amended 2001;338.240, RSMo 1951; and 338.280, RSMo 1951, amended1971, 1981.

20 CSR 2220-2.013 Prescription DeliveryRequirements

PURPOSE: This rule establishes require-ments for authorized prescription deliverysites.

(1) Every pharmacy delivering prescriptiondrugs shall develop and implement written

policies and procedures to ensure the safe andappropriate delivery of prescription drugswithin the temperature requirements recom-mended by the manufacturer or the UnitedStates Pharmacopeia (USP). Except as other-wise provided herein, prescriptions filled bya Missouri licensed pharmacy may not be leftat, accepted by, or delivered to a location,place of business or entity not licensed as apharmacy.

(2) At the request of the patient or thepatient’s authorized designee, licensees maydeliver a filled prescription for an individualpatient directly to the patient or the patient’sauthorized designee or to—

(A) The office of a licensed health carepractitioner authorized to prescribe medica-tion in the state of Missouri;

(B) A long-term care facility as defined by20 CSR 2220-2.140 where the patientresides;

(C) A hospital, office, clinic, or othermedical institution that provides health careservices;

(D) A residence designated by the patientor the patient’s authorized designee; or

(E) The patient’s office or place of employ-ment.

(3) At the request of a customer, legally filledprescriptions for veterinary use may be deliv-ered to a residence, business, or clinic desig-nated by the customer.

(4) Licensees shall comply with all applicablecontrolled substance laws and regulations,including, but not limited to, all applicablesecurity requirements.

(5) Returns of medication delivered pursuantto this section shall be governed by, and han-dled in accordance with, Chapter 338,RSMo, and the rules of the board.

AUTHORITY: section 338.280, RSMo 2000,and sections 338.095, 338.100, 338.140, and338.240, RSMo Supp. 2011.* Original rulefiled May 14, 2012, effective Nov. 30, 2012.

*Original authority: 338.095, RSMo 1993, amended 2007;338.100, RSMo 1939, amended 1971, 1990, 1997, 1999,2010; 338.140, RSMo 1939, amended 1981, 1989, 1997,2011; 338.240, RSMo 1951, amended 2011; and 338.280,RSMo 1951, amended 1971, 1981.

20 CSR 2220-2.015 Termination of Busi-ness as a Pharmacy

PURPOSE: This rule establishes guidelinesfor the termination of business as a pharma-cy.

(1) A licensed pharmacy who plans to termi-nate business activities shall file a writtennotice with the State Board of Pharmacy. Thewritten notice shall be submitted to the StateBoard of Pharmacy in person or by registeredor certified mail within fifteen (15) days afterthe date of termination. This notice shall bemade on a form provided by the board or inletter form from the licensee and shallinclude the following information:

(A) The name, address, license (permit)number and effective date of closing;

(B) The name, address, and license (per-mit) number of the entity to which any of thestock/inventory will be transferred;

(C) The name and address of the locationto which records, required to be maintainedby law, have been transferred.

1. Any records that are transferred to anunlicensed location must be retrievable forboard review within seven (7) working daysof a request made by an authorized official ofthe board.

2. Any records that are transferred to alicensed (permitted) pharmacy or licenseddrug distributor must be maintained in accor-dance with record requirements as set forth insection 338.100, RSMo.

(2) The licensee (permit holder) terminatingbusiness may transfer all drugs and records inaccordance with the following:

(A) On the date of termination, a completeinventory of all controlled substances beingtransferred or disposed of shall be completedaccording to state and federal laws. Thisinventory shall serve as the final inventory ofthe pharmacy terminating business and as theinitial inventory of the licensed entity towhich the controlled substances are beingtransferred. A copy of the inventory shall beincluded in the records of each licensee orpermit holder involved in the transfer.

(B) A pharmacy terminating business shallnot transfer misbranded, outdated or adulter-ated drugs, except for purposes of proper dis-posal; and

(C) Upon the actual termination of busi-ness, the license (permit) of the pharmacyshall be returned to the State Board of Phar-macy for cancellation either in person or byregistered or certified mail.

(3) A one (1)-time transfer of drugs anddevices due to a termination of business thatis in compliance with this rule will notrequire a pharmacy to seek licensure as adrug distributor under sections 338.330 and338.333, RSMo.

(4) The requirements of this rule are notintended to replace or be in conflict with anyother laws or regulations governing the

6 CODE OF STATE REGULATIONS (10/31/12) ROBIN CARNAHAN

Secretary of State


CODE OF STATE REGULATIONS 7JASON KANDER (6/30/16)Secretary of State


appropriate licensure, change of ownership orchange of location of a pharmacy.

(5) The termination date is the date on whichthe permit holder ceases to practice pharmacyas defined in sections 338.010 and 338.210,RSMo, at the permitted location.

AUTHORITY: sections 338.210 and 338.280,RSMo 1994.* This rule originally filed as 4CSR 220-2.015. Original rule filed May 4,1995, effective Dec. 30, 1995. Moved to 20CSR 2220-2.015, effective Aug. 28, 2006.

*Original authority: 338.210, RSMo 1951 and 338.280,RSMo 1951, amended 1971, 1981.

20 CSR 2220-2.016 Pharmacy OperatingProcedures During Declared Disasters

PURPOSE: This rule is to establishes guide -lines for the operation and temporary reloca-tion of a pharmacy during a declared disas-ter.

(1) Declared disaster areas are defined asspecified geographical counties within thestate that have been designated by the gover-nor or federal authorities as counties thathave been adversely affected by a natural orman-made disaster and requires extraordinarymeasures to provide adequate, safe and effec-tive health care for the affected population.

(2) In cases where a disaster as defined insection (1) has been declared, any pharmacylocated within the disaster area may arrangeto move to a temporary location to betterserve the public or provide pharmacy servicesfrom a mobile unit that is under the controland management of the pharmacist-in-charge.

(A) The following constitutes requirementsfor maintaining temporary or mobile facili-ties:

1. Temporary or mobile pharmacy facil-ities shall only be located within the disasterarea or adjacent county;

2. Temporary facilities may be main-tained by a pharmacy operation for a periodof up to six (6) months without applying fora change of location. Any pharmacy wishingto maintain a temporary site for more than six(6) months or desires to remain permanentlyat the temporary site, must apply for a changeof location as outlined in 4 CSR 220-2.020(4);

3. Mobile pharmacy operations mustcease services once the immediate disaster isover;

4. Temporary or mobile pharmacy facil-ities must inform the board of their locationand provide an estimate of the time period for

which the temporary or mobile pharmacyoperation will be needed; and

5. The executive director shall have theauthority to approve or disapprove temporaryor mobile pharmacy facilities and shall makearrangements for appropriate monitoring andinspection of the pharmacy on a case by casebasis.

A. Approval of this type of operationwill be based on the need, type and scope ofdisaster, as well as the ability of the pharmacyto comply with state and federal drug laws inaddition to section 338.240, RSMo.

B. Temporary or mobile pharmacyfacilities shall cease operations under the pro-visions of this rule if any previous approval iswithdrawn.

C. Any decision made concerning theapproval of a temporary or mobile pharmacyshall not interfere with any rights or privi-leges of a pharmacy permit holder at the orig-inal location of operation or prevent a permitholder from applying for a change of locationas outlined in 4 CSR 220-2.020(4).

AUTHORITY: sections 338.210 and 338.280,RSMo 1994.* This rule originally filed as 4CSR 220-2.016. Original rule filed May 4,1995, effective Dec. 30, 1995. Moved to 20CSR 2220-2.016, effective Aug. 28, 2006.

*Original authority: 338.210, RSMo 1951 and 338.280,RSMo 1951, amended 1971, 1981.

20 CSR 2220-2.017 Non-Electronic (Manu-al) Prescription Records

PURPOSE: This rule establishes require-ments for non-electronic (manual) prescrip-tion record keeping.

(1) Pharmacies that maintain a non-electronicprescription record system shall maintain thefollowing information in its system for eachoriginal and refilled prescription:

(A) The date the prescription was pre-scribed and the date of initial dispensing, ifdifferent;

(B) A unique, sequential prescription labelnumber;

(C) If applicable, a unique readily retriev-able identifier;

(D) The name of the patient(s), or if ananimal, species and owner’s name;

(E) The prescriber’s name, if an oral pre-scription, signature if a written or faxed pre-scription. Electronic signatures shall complywith all applicable provisions of 20 CSR2220-2.085;

(F) Name, strength and dosage of drug,device or poison dispensed and the directionsfor use;

(G) The number of refills authorized;(H) The quantity dispensed in weight, vol-

ume, or number of units;(I) The date of refill, if any;(J) The identity of the pharmacist respon-

sible for reviewing the accuracy of data oneach original prescription;

(K) The identity of the pharmacist respon-sible for verifying the final product prior todispensing on each original and refill pre-scription, if different;

(L) Whether generic substitution has beenauthorized by the prescriber;

(M) Any change or alteration made to theprescription dispensed based on contact withthe prescriber to show a clear audit trail. Thisshall include, but is not limited to, a changein quantity, directions, number of refills, orauthority to substitute a drug;

(N) The address of the prescriber and thepatient when the prescription is for a con-trolled substance;

(O) The prescriber’s Drug EnforcementAdministration (DEA) number when the pre-scription is for a controlled substance; and

(P) If additional refills are authorized andadded to the prescription, a notation indicat-ing the method and source of the authoriza-tion must be a part of the manual record orhard copy, in such case the expiration date ofthe original prescription shall remain thesame; and

(Q) Any prescription, when it is for a con-trolled substance, must comply with allrequirements of federal and state controlledsubstance laws.

(2) The information specified in section (1)shall be required and recorded on all pre-scriptions prior to dispensing by a pharma-cist/pharmacy.

(3) Prescription hard copies must be main-tained and filed sequentially by the prescrip-tion label number or a unique readily retriev-able identifier. Except as otherwise providedby 20 CSR 2220-2.010(1)(J), prescriptionhard copies shall be retrievable at the time ofinspection.

AUTHORITY: sections 338.095, 338.100,338.140, and 338.240, RSMo Supp. 2012,and section 338.280, RSMo 2000.* Originalrule filed Jan. 10, 2013, effective Aug. 30,2013.

*Original authority: 338.095, RSMo 1993, amended 2007;338.100, RSMo 1939, amended 1971, 1990, 1997, 1999,2010; 338.140, RSMo 1939, amended 1981, 1989, 1997,2011; and 338.240, RSMo 1951, amended 2011.

20 CSR 2220-2.018 Prescription Require-ments

PURPOSE: This rule establishes require-ments for information required on prescrip-tions.

(1) To be valid for purposes of dispensing, aprescription shall conform to all requirementsof sections 338.056 or 338.196, RSMo, andshall contain the following information:

(A) The date of prescribing;(B) The name of the patient(s), or if an ani-

mal, species and owner’s name;(C) The prescriber’s name, if an oral pre-

scription, or written or electronic signature ifa written, faxed, or an electronically trans-mitted prescription. Electronic signaturesshall comply with all applicable provisions of20 CSR 2220-2.085;

(D) Name, strength and dosage of drug,device or poison prescribed and the direc-tions for use;

(E) The number of refills, if applicable;(F) The quantity prescribed in weight, vol-

ume, or number of units;(G) An indication of whether generic sub-

stitution has been authorized by the pre-scriber, as required by section 338.056,RSMo;

(H) Any change or alteration made to theprescription dispensed based on contact withthe prescriber to show a clear audit trail.This shall include, but is not limited to, achange in quantity, directions, number ofrefills, or authority to substitute a drug;

(I) The address of the prescriber and thepatient when the prescription is for a con-trolled substance;

(J) The prescriber’s Drug EnforcementAdministration (DEA) number when the pre-scription is for a controlled substance; and

(K) Controlled substance prescriptionsshall also comply with all requirements offederal and state controlled substance laws.

AUTHORITY: sections 338.095, 338.100,338.140, and 338.240, RSMo Supp. 2012,and section 338.280, RSMo 2000.* This ruleoriginally filed as 4 CSR 220-2.018. Originalrule filed May 4, 1995, effective Dec. 30,1995. Amended: Filed March 15, 2000,effective Sept. 30, 2000. Amended: Filed Nov.1, 2000, effective June 30, 2001. Moved to 20CSR 2220-2.018, effective Aug. 28, 2006.Amended: Filed Jan. 10, 2013, effective Aug.30, 2013.

*Original authority: 338.095, RSMo 1993, amended 2007;338.100, RSMo 1939, amended 1971, 1990, 1997, 1999,2010; 338.140, RSMo 1939, amended 1981, 1989, 1997,2011; and 338.240, RSMo 1951, amended 2011.

20 CSR 2220-2.020 Pharmacy Permits

PURPOSE: This rule outlines the require-ments for obtaining and maintaining a phar-macy permit.

(1) All permits for the operation of a pharma-cy shall expire on the date specified by thedirector of the Division of Professional Reg-istration pursuant to 20 CSR 2231-2.010.

(2) A pharmacy permit may be issued on theapplication of the owners. If the owner is acorporation, an officer of the corporationmust sign the application as the applicant. Ifthe owner is a partnership, a partner mustsign the application as the applicant. If theowner is a limited liability partnership, a gen-eral partner must sign the application as theapplicant. If the owner is a limited liabilitycompany, a member must sign the applicationas the applicant. In the case where a pharma-cy is owned and operated by a person(s) whois a licensed pharmacist and in active chargeof the pharmacy, the application for permitcan be made by either party. Alternatively, apharmacy permit application may be signedby an attorney or other person lawfully grant-ed power of attorney to sign the applicationon the applicant’s behalf. In such case, a rep-resentative of the applicant shall review theapplication for truth and accuracy prior tosubmitting the application to the board. Proofof a power of attorney designation shall besubmitted with the application.

(A) An application for a pharmacy permitwill become null and void if the applicantfails to complete the process for licensurewithin six (6) months of receipt of the appli-cation by the board.

(3) When a pharmacy changes ownership, theoriginal permit becomes void on the effectivedate of the change of ownership. Before anynew business entity resulting from the changeopens a pharmacy for business, it must obtaina new permit from the board. A temporarylicense shall be issued once a completed appli-cation and fee have been received by theboard. The effective date of the temporarylicense may be the date the change of owner-ship is listed as effective on the application.Such license shall remain in effect until a per-manent license is issued or denied by theboard.

(A) A change of ownership of a pharmacyowned by a sole proprietor is deemed to haveoccurred when—

1. The business is sold and the salebecomes final;

2. The proprietor enters into a partner-ship with another individual or business enti-ty; or

3. The proprietor dies; provided, how-

ever, that the proprietor’s estate may continueto operate the pharmacy under the licensedpharmacist in good standing in this state, butin no case for a period of more than one (1)year and only so long as appropriate pharma-cy permit fees are paid.

(B) If a corporation owns a pharmacy, it isnot necessary to obtain a new license if theowners of the stock change. If a limited lia-bility partnership or a limited liability compa-ny owns a pharmacy, it is not necessary toobtain a new license if the partners or mem-bers of the company change, as long as thepartnership or company is not dissolved bythat change. It is necessary to file writtennotice with the State Board of Pharmacywithin ten (10) days after a change occurs inpartners in a limited liability partnership, orin members in a limited liability company.This notification must be in writing and cer-tified. However, when a corporation, limitedliability partnership, or limited liability com-pany begins ownership of a pharmacy ortransfers ownership of a pharmacy, a newlicense must be obtained regardless of therelationship between the previous and subse-quent owners.

(C) All individuals or business entities own-ing twenty-five percent (25%) or more of theownership of any entity owning a pharmacymust notify the board within thirty (30) daysof acquiring the percentage.

(4) If an individual or business entity operat-ing a pharmacy changes the location of thepharmacy to a new facility (structure), thepharmacy shall not open for business at thenew location until the board or its duly autho-rized agent has inspected the premises of thenew location and approved it and the pharma-cy as being in compliance with section338.240, RSMo and all other provisions of thelaw. Upon the approval and receipt of a changeof location fee, the board shall issue a permitauthorizing operation of a pharmacy at thenew location, and the permit shall bear thesame number as the previous pharmacy per-mit. However, the permit remains valid if thepharmacy address changes, but not the loca-tion, and an amended permit will be issuedwithout charge under these circumstances.

(A) Remodeling of a licensed pharmacywithin an existing structure shall be deemedto have occurred when any change in the stor-age conditions of the Schedule II controlledsubstances is made or new connections towater/sewer resources are made or anychanges in the overall physical security ofdrugs stored in the pharmacy as defined in 20CSR 2220-2.010(1)(H) are made. Remodel-ing as defined within this section will notrequire the initiation of any change of loca-tion procedures. Satisfactory evidence ofplans for any remodeling of a pharmacy must

8 CODE OF STATE REGULATIONS (6/30/16) JASON KANDER

Secretary of State


be provided to the board office thirty (30)days in advance of commencing such changesalong with an affidavit showing any changesto the pharmacy physical plant and the pro-jected completion date for any remodeling.

(5) Permits, when issued, will bear an origi-nal number. Permits must be posted in a con-spicuous place in the pharmacy to which it isissued.

(6) No pharmacy permit will be issued unlessthe pharmacy area is under the direct supervi-sion of a licensed pharmacist in good standingwith the Missouri State Board of Pharmacywho is designated as the pharmacist-in-chargeand meets the requirements of 20 CSR 2220-2.090.

(7) If the owner/applicant is not the licensedpharmacist-in-charge, then the pharmacist-in-charge must meet the requirements of 20 CSR2220-2.090 and complete the pharmacist-in-charge affidavit of the permit application.

(8) The names of all pharmacists regularlyworking in a pharmacy shall be clearly dis-played on the premises of every establishmenthaving a pharmacy permit.

(9) The following classes of pharmacy per-mits or licenses are hereby established forentities providing services as defined in sec-tion 338.010, RSMo:

(A) Class A: Community/Ambulatory. Apharmacy that provides services as defined insection 338.010, RSMo to the general public;

(B) Class B: Hospital Pharmacy. Apharmacy owned, managed, or operated by ahospital as defined by section 197.020,RSMo, or a clinic or facility under commoncontrol, management, or ownership of thesame hospital or hospital system. This sectionshall not be construed to require a Class Bhospital pharmacy permit or license forhospitals solely providing services within thepractice of pharmacy under the jurisdictionof, and the licensure granted by, theDepartment of Health and Senior Servicesunder and pursuant to Chapter 197, RSMo;

(C) Class C: Long-Term Care. A pharma-cy that provides services as defined in section338.010, RSMo by the dispensing of drugsand devices to patients residing within long-term care facilities. A long-term care facilitymeans a nursing home, retirement care, men-tal care or other facility or institution whichprovides extended health care to residentpatients;

(D) Class D: Non-Sterile Compounding. Apharmacy that provides services as defined insection 338.010, RSMo and provides a non-sterile compounded product as defined in 20CSR 2220-2.400(1) and meets the followingcriteria:

1. Any product made from any bulk

active ingredient in a batch quantity asdefined in 20 CSR 2220-2.400(3);

(E) Class E: Radiopharmaceutical. A phar-macy that is not open to the general publicand provides services as defined in section338.010, RSMo that prepares and dispensesradioactive drugs as defined by the Food andDrug Administration (FDA) and drugs relatedto the use of radioactive drugs to health careproviders for use in the treatment or diagnosisof disease and that maintains a qualifiednuclear pharmacist as the pharmacist-in-charge;

(F) Class F: Renal Dialysis. A pharmacythat is not open to the general public that pro-vides services as defined in section 338.010,RSMo limited to the dispensing of renal dial-ysis solutions and other drugs and devicesassociated with dialysis care;

(G) Class G: Medical Gas. A pharmacythat provides services as defined in section338.010, RSMo through the provision of oxy-gen and other prescription gases for therapeu-tic uses;

(H) Class H: Sterile Product Compounding.A pharmacy that provides services as definedin section 338.010, RSMo, and provides asterile pharmaceutical as defined in 20 CSR2220-2.200;

(I) Class I: Consultant. A location whereany activity defined in section 338.010,RSMo is conducted, but which does notinclude the procurement, storage, possessionor ownership of any drugs from the location;

(J) Class J: Shared Service. A pharmacyengaged in the processing of a request fromanother pharmacy to fill or refill a prescrip-tion drug order, or that performs or assists inthe performance of functions associated withthe dispensing process, drug utilizationreview (DUR), claims adjudication, refillauthorizations, and therapeutic interventions;

(K) Class K: Internet. A pharmacy thatprovides services as defined in section338.010, RSMo, and is involved in thereceipt, review, preparation, compounding,dispensing, or offering for sale any drugs,chemicals, medicines, or poisons for any newprescriptions originating from the Internet forgreater than ninety percent (90%) of the totalnew prescription volume on any day;

(L) Class L: Veterinary. A pharmacyengaged in the sale, dispensing, or filling ofa legend drug for use in animals that mustonly be dispensed by prescription under stateor federal law, provided that an additionalClass L pharmacy permit shall not berequired for pharmacies holding a Class Apharmacy permit that are also engaged in thesale, dispensing, or filling of a legend drugfor animal use;

(M) Class M: Specialty (bleeding disor-der). A pharmacy that provides blood-clottingproducts and ancillary infusion equipment orsupplies to patients with bleeding disorders,as defined by 20 CSR 2220-6.100;

(N) Class N: Automated dispensing system(health care facility). An automated dispens-ing system as defined in 20 CSR 2220-2.900that is located in a facility where medical ser-vices are provided to patients on the premisesof or at the same physical location as suchfacility;

(O) Class O: Automated dispensing system(ambulatory care). An automated dispensingsystem as defined in 20 CSR 2220-2.900 thatis not located in a healthcare facility identi-fied in subsection (9)(N) of this rule; and

(P) Class P: Practitioner office/clinic. Apharmacy that is located in or on the premisesof an office or clinic of a healthcare practi-tioner licensed in the United States who isauthorized to prescribe medication by lawand that provides pharmacy services asdefined in section 338.010, RSMo, solely forpatients of such practitioner or practitioners.

(10) Pharmacy applications for initial licen-sure or renewals of a license shall accuratelynote each class of pharmacy that is practicedat the location noted on the application orrenewal thereof. The permit (license) issuedby the board shall list each class of licensurethat the pharmacy is approved to engage in. APharmacy Change of Classification Applica-tion shall be filed with the board prior toadding or deleting any pharmacy classes withthe applicable fee.

(11) Prescriptions processed by any classifi-cation of licensed pharmacy must be providedby a practitioner licensed in the UnitedStates, authorized by law to prescribe drugs,and who has performed a medical evaluationof the patient as required by law. A pharma-cist shall not dispense a prescription drug ifthe pharmacist has knowledge, or reasonablyshould know under the circumstances, thatthe prescription order for such drug wasissued on the basis of an Internet-based ques-tionnaire or without a valid pre-existingpatient-practitioner relationship.

AUTHORITY: section 338.140, RSMo Supp.2013, and section 338.280, RSMo 2000.*This rule originally filed as 4 CSR 220-2.020.Original rule filed July 18, 1962, effectiveJuly 28, 1962. Amended: Filed Nov. 9, 1966,effective Nov. 19, 1966. Amended: Filed Oct.27, 1970, effective Nov. 6, 1970. Amended:Filed Dec. 31, 1975, effective Jan. 10, 1976.Emergency amendment filed July 15, 1981,effective Sept. 28, 1981, expired Nov. 11,1981. Amended: Filed Aug. 10, 1981, effec-tive Nov. 12, 1981. Amended: Filed April 14,1982, effective July 11, 1982. Amended: FiledMarch 14, 1983, effective June 11, 1983.Amended: Filed Feb. 11, 1985, effective May11, 1985. Amended: Filed Dec. 16, 1985,effective May 11, 1986. Amended: Filed Aug.1, 1986, effective Nov. 13, 1986. Amended:Filed Jan. 27, 1995, effective Sept. 30, 1995.



Amended: Filed Jan. 6, 1998, effective Aug.30, 1998. Amended: Filed June 29, 1999,effective Jan. 30, 2000. Amended: FiledMarch 15, 2000, effective Sept. 30, 2000.Amended: Filed Nov. 30, 2001, effective June30, 2002. Amended: Filed Dec. 3, 2002,effective June 30, 2003. Amended: Filed May13, 2005, effective Oct. 30, 2005. Moved to20 CSR 2220-2.020, effective Aug. 28, 2006.Amended: Filed Aug. 21, 2006, effectiveApril 30, 2007. Emergency amendment filedJan. 19, 2016, effective Feb. 2, 2016, expiredJuly 30, 2016. Amended: Filed Jan. 19, 2016,effective July 30, 2016.

*Original authority: 338.140, RSMo 1939, amended 1981,1989, 1997, 2011 and 338.280, RSMo 1951, amended1971, 1981.

20 CSR 2220-2.025 Nonresident Pharma-cies

PURPOSE: This rule establishes licensureguidelines for nonresident pharmacies.

(1) Nonresident pharmacies shall not ship,mail, or deliver prescription drugs into Mis-souri without first obtaining a pharmacylicense from the Missouri Board of Pharma-cy. An exemption to licensure is allowedwhen a nonresident pharmacy provides a pre-scription drug in an emergency situation orsupplies lawful refills to a patient from a pre-scription that was originally filled and deliv-ered to a patient within the state in which thenonresident pharmacy is located.

(2) To obtain a Missouri pharmacy license, anonresident pharmacy must—

(A) Maintain a pharmacy license in goodstanding from the state in which the nonresi-dent pharmacy is located;

(B) Submit an application as provided bythe Missouri Board of Pharmacy for licensurein compliance with 20 CSR 2220-2.020(2),(3), (9), and (10);

(C) Pay all appropriate licensing fees;(D) Submit a copy of the state pharmacy

license from the state in which the nonresi-dent pharmacy is located;

(E) If controlled substances will be shippedinto Missouri, submit a copy of the appli-cant’s federal controlled substance registra-tion and, if applicable, a copy of the appli-cant’s state controlled substance registrationfrom the state where the applicant is located;

(F) If the designated pharmacist-in-chargedoes not have a current and active Missouripharmacist license issued by the board, sub-mit an official verification from the stateboard of pharmacy or equivalent state phar-macist licensing agency verifying that thedesignated pharmacist-in-charge holds a cur-rent and active pharmacist license in the statein which the nonresident pharmacy is locat-

ed; and(G) Submit a copy of the applicant’s most

recent pharmacy inspection by the applicant’sresident state board of pharmacy or its equiv-alent state regulatory body. The inspectionmust have occurred within the last eighteen(18) months for sterile compounding pharma-cy applicants or within the last twenty-four(24) months for all other pharmacy appli-cants. If a state inspection is unavailable, aninspection by the Missouri Board of Pharma-cy or from the Verified Pharmacy Program(VPP) of the National Association of StateBoards of Pharmacy or a similar inspectionby an entity approved by the board may beaccepted.

(3) Each nonresident pharmacy shall supplyany inspection reports, warning notices,notice of deficiency reports, or any otherrelated reports requested by the board or theboard’s authorized designee to review com-pliance with state and federal drug laws.

(4) The Missouri Board of Pharmacy willextend reciprocal cooperation to any state thatlicenses and regulates nonresident pharma-cies for the purpose of investigating com-plaints against pharmacies located in Mis-souri or the sharing of information andinvestigative reports, as long as the otherstate will extend the same reciprocal cooper-ation to the Missouri Board of Pharmacy.

AUTHORITY: sections 338.140, 338.210.4,338.220, 338.240, and 338.280, RSMo2016.* This rule originally filed as 4 CSR220-2.025. Original rule filed Jan. 16, 1990,effective May 11, 1990. Amended: Filed June28, 2002, effective Jan. 30, 2003. Moved to20 CSR 2220-2.025, effective Aug. 28, 2006.Amended: Filed Oct. 10, 2017, effective April30, 2018.

*Original authority: 338.140, RSMo 1939, amended 1981,1989, 1997, 2011; 338.210, RSMo 1951, amended 2001,2011; 338.220, RSMo 1951, amended 1969, 1981, 1989,1997, 1999, 2001, 2004, 2007, 2009, 2011, 2013, 2014;338.240, RSMo 1951, amended 2011; and 338.280, RSMo1951, amended 1971, 1981.

20 CSR 2220-2.030 Educational and Licens-ing Requirements(Rescinded August 30, 2013)

AUTHORITY: sections 338.020, 338.040,338.070, 338.140, and 338.280, RSMo 2000,and sections 338.030 and 338.035, RSMoSupp. 2007. This rule originally filed as 4CSR 220-2.030. This version of rule filed July18, 1962, effective July 28, 1962. Amended:Filed Nov. 9, 1966, effective Nov. 19, 1966.Amended: Filed Nov. 27, 1967, effective Dec.7, 1967. Amended: Filed Sept. 30, 1969,effective Oct. 10, 1969. Amended: Filed Dec.31, 1975, effective Jan. 10, 1976. Emergency

amendment filed July 15, 1981, effectiveSept. 28, 1981, expired Nov. 11, 1981.Amended: Filed Aug. 10, 1981, effective Nov.12, 1981. Amended: Filed April 14, 1982,effective July 11, 1982. Amended: Filed Dec.12, 1983, effective May 11, 1984. Amended:Filed Dec. 11, 1984, effective March 11,1985. Amended: Filed June 14, 1985, effec-tive Aug. 26, 1985. Amended: Filed Feb. 25,1986, effective June 12, 1986. Amended:Filed Oct. 1, 1987, effective Jan. 29, 1988.Amended: Filed Jan. 3, 1990, effective April26, 1990. Amended: Filed Jan. 30, 1991,effective July 8, 1991. Amended: Filed Jan.3, 1992, effective June 25, 1992. Amended:Filed Aug. 4, 1992, effective April 8, 1993.Amended: Filed Sept. 26, 1994, effectiveMarch 30, 1995. Amended: Filed Jan. 27,1995, effective Sept. 30, 1995. Amended:Filed March 19, 1996, effective Oct. 30,1996. Amended: Filed Dec. 9, 1996, effectiveJuly 30, 1997. Amended: Filed April 23,1998, effective Nov. 30, 1998. Amended:Filed Nov. 1, 2000, effective June 30, 2001.Amended: Filed June 28, 2002, effective Jan.30, 2003. Amended: Filed Nov. 13, 2002,effective June 30, 2003. Amended: Filed Dec.1, 2004, effective June 30, 2005. Moved to 20CSR 2220-2.030, effective Aug. 28, 2006.Amended: Filed Feb. 6, 2008, effective Aug.30, 2008. Rescinded: Filed Jan. 10, 2013,effective Aug. 30, 2013.

20 CSR 2220-2.032 Licensure by Exami-nation for Graduates of Nonapproved For-eign Pharmacy Schools(Rescinded August 30, 2013)

AUTHORITY: sections 338.020, 338.030,and 338.140, RSMo 2000. This rule original-ly filed as 4 CSR 220-2.032. Original rulefiled Oct. 16, 1985, effective Feb. 24, 1986.Amended: Filed Dec. 24, 1990, effective June10, 1991. Amended: Filed Dec 15, 1995,effective July 30, 1996. Amended: Filed Nov.21, 1997, effective June 30, 1998. Amended:Filed March 1, 2001, effective Sept. 30, 2001.Moved to 20 CSR 2220-2.032, effective Aug.28, 2006. Rescinded: Filed Jan. 10, 2013,effective Aug. 30, 2013.

20 CSR 2220-2.034 Licensure by Reciproc-ity for Graduates of Nonapproved ForeignPharmacy Schools Who Have Been Licen-sed in Another State(Rescinded August 30, 2013)

AUTHORITY: sections 338.020 and 338.030,RSMo Supp. 1990. This rule originally filedas 4 CSR 220-2.034. Original rule filed Oct.16, 1985, effective Feb. 24, 1986. Amended:Filed Aug. 29, 1986, effective Dec. 25, 1986.Amended: Filed Dec. 24, 1990, effective June10, 1991. Moved to 20 CSR 2220-2.034,


Secretary of State


effective Aug. 28, 2006. Rescinded: FiledJan. 10, 2013, effective Aug. 30, 2013.

20 CSR 2220-2.036 Temporary License(Rescinded August 30, 2013)

AUTHORITY: section 338.140, RSMo 2000,and section 338.043, RSMo Supp. 2007. Thisrule originally filed as 4 CSR 220-2.036.Original rule filed May 24, 1993, effectiveDec. 9, 1993. Amended: Filed Nov. 21, 1997,effective June 30, 1998. Amended: FiledMarch 15, 2000, effective Sept. 30, 2000.Moved to 20 CSR 2220-2.036, effective Aug.28, 2006. Amended: Filed Feb. 6, 2008,effective Aug. 30, 2008. Rescinded: FiledJan. 10, 2013, effective Aug. 30, 2013.

20 CSR 2220-2.050 Public Complaint Han-dling and Disposition Procedure

PURPOSE: This rule establishes a procedurefor the receipt, handling and disposition ofpublic complaints by the board, pursuant tothe mandate of section 620.010.16(6), RSMo.

(1) The State Board of Pharmacy shall receiveand process each complaint made against anylicensee or registrant or other person or entity,which complaint alleges certain acts or prac-tices which may constitute one (1) or moreviolations of the provisions of Chapter 338,RSMo. Any member of the public, the profes-sion or any federal, state or local official maymake and file a complaint with the board.Complaints shall be received from sourcesoutside Missouri and will be processed in thesame manner as those originating within Mis-souri. No member of the State Board of Phar-macy shall file a complaint with this boardwhile s/he holds that office, unless that mem-ber excuses him/herself from further boarddeliberations or activity concerning the mat-ters alleged within that complaint. Any staffmember or employee of the board may file acomplaint pursuant to this rule in the samemanner as any member of the public.

(2) Complaints should be mailed or deliveredto the following address: State Board of Phar-macy, 3605 Missouri Blvd., PO Box 625, Jef-ferson City, MO 65102. However, actualreceipt of the complaint by the board at itsadministrative offices in any manner shall besufficient. Complaints may be based uponpersonal knowledge or upon information andbelief, reciting information received fromother sources.

(3) All complaints shall be made in writingand shall fully identify their maker by nameand address. Complaints may be made onforms provided by the board, which shall beavailable upon request. Complaints need not

be made by affidavit, but oral or telephonecommunications will not be considered orprocessed as complaints. Any person attempt-ing to make an oral or telephone complaintagainst an individual will be provided with acomplaint form and requested to complete itand return it to the board. Any staff memberor employee of the board may make and filea complaint based upon information andbelief, in reliance upon oral, telephone orwritten but unsigned communicationsreceived by the board, unless those commu-nications are believed by that staff member oremployee to be false.

(4) Each complaint received under this ruleshall be recorded by the board. Complaintsshall be logged in consecutive order asreceived. The record shall contain each com-plainant’s name and address; the name andaddress of the subject(s) of the complaint; thedate each complaint is received by the board;a brief statement of the acts complained of,and the ultimate disposition of the complaint.This record shall be a closed record of theboard.

(5) The complainant shall be informed inwriting as to whether the complaint has beendismissed by the board or is being referred tolegal counsel for legal action. The com-plainant may be notified of the ultimate dis-position of the complaint, excluding judicialappeals and may be provided with a copy ofthe decisions (if any) of the AdministrativeHearing Commission and the board. The pro-visions of this section shall not apply to com-plaints filed by staff members or employeesof the board, based upon information andbelief, acting in reliance on third-party infor-mation received by the board.

(6) Both the complaint and any informationobtained as a result of the complaint investi-gation shall be considered a closed record ofthe board and shall not be available forinspection by the public.

(7) This rule shall not be deemed to limit theboard’s authority to file a complaint with theAdministrative Hearing Commission or witha court, charging a licensee, permittee orother person or entity with any actionableconduct or violation, whether or not thiscomplaint exceeds the scope of the actscharged in a preliminary public complaintfiled with the board and whether or not anypublic complaint has been filed with theboard.

(8) The board interprets this rule, which isrequired by law, to exist for the benefit ofthose members of the public who submitcomplaints to the board. This rule is notdeemed to protect, or to inure to the benefitof those licensees, permit holders, registrants

or other persons or entities against whom theboard has instituted or may institute adminis-trative or judicial proceedings concerningpossible violations of provisions of Chapter338, RSMo.

(9) To facilitate the investigation, evaluationand disposition of complaints, which involveviolations of federal and state law governingcontrolled substances, the Board of Pharmacymay designate Bureau of Narcotics and Dan-gerous Drugs personnel and other state per-sonnel as pharmacy inspectors. These inspec-tors shall be authorized pursuant to section338.150, RSMo to enter and inspect variouspremises.

(10) Persons designated by the Board of Phar-macy as pharmacy inspectors and other Boardof Pharmacy personnel may attend boardmeetings in order to assist the board in itsdeliberations.

AUTHORITY: sections 338.140 and 338.280,RSMo 2000 and 620.010.15(6), RSMo Supp.2004.* This rule originally filed as 4 CSR220-2.050. Original rule filed Jan. 11, 1982,effective June 1, 1982. Amended: Filed Aug.27, 1985, effective Nov. 11, 1985. Amended:Filed Aug. 29, 1986, effective Dec. 25, 1986.Amended: Filed Sept. 26, 1994, effectiveMarch 30, 1995. Amended: Filed June 28,2002, effective Jan. 30, 2003. Amended:Filed May 13, 2005, effective Oct. 30, 2005.Moved to 20 CSR 2220-2.050, effective Aug.28, 2006.

*Original authority: 338.140, RSMo 1939, amended 1981,1989, 1997; 338.280, RSMo 1951, amended 1971, 1981;and 620.010.15(6), RSMo 1973, amended 1981, 1983,1986, 1989, 1990. 1993, 1994, 1995, 1999, 2001.

20 CSR 2220-2.060 Gold Certificates

PURPOSE: This rule sets requirements con-cerning the issuance of honorary gold certifi-cates to pharmacists licensed in Missouri forfifty years.

(1) The Missouri Board of Pharmacy shallissue gold certificates to all pharmacistlicensees who have been regularly licensed aspharmacists in Missouri for fifty (50) years.These gold certificates shall be distinctive incoloration and text from other documentarylicenses issued by the board and shall bedesigned to appropriately recognize eachrecipient pharmacist for his/her half centuryof professional practice. Gold certificates arehonorific in nature and confer no right topractice pharmacy upon the recipient.

(2) The awarding of gold certificates shall bemade by the Missouri Board of Pharmacyroutinely and without charge to the recipient.



AUTHORITY: section 338.140, RSMo Supp.1989.* This rule originally filed as 4 CSR220-2.060. Original rule filed March 14,1983, effective June 11, 1983. Moved to 20CSR 2220-2.060, effective Aug. 28, 2006.

*Original authority: 338.140, RSMo 1939, amended 1981,1989.

20 CSR 2220-2.080 Electronic PrescriptionRecords

PURPOSE: This rule establishes require-ments for utilizing an electronic data-process-ing system in a pharmacy.

(1) In lieu of a non-electronic (manual)record-keeping system, a pharmacy may electto maintain an electronic data processing(EDP) record keeping-system. All informationconcerning the compounding, dispensing, orselling by a pharmacy of any drug, device, orpoison pursuant to a lawful prescription whichis entered into an EDP system at any pharma-cy shall be entered only by a licensed pharma-cist or by a technician or intern pharmacistunder the direct supervision and review of alicensed pharmacist. Prior to dispensing, apharmacist shall personally verify the accura-cy of prescription data entered into the EDPfor each original prescription. The EDP sys-tem shall comply with all applicable state andfederal controlled substance laws and regula-tions.

(2) EDP systems shall comply with therequirements of section 338.100, RSMo, andshall be capable of storing and retrieving thefollowing information concerning the originalfilling or refilling of any prescription:

(A) A unique, sequential prescription labelnumber;

(B) If applicable, a unique readily retriev-able identifier;

(C) Date the prescription was prescribed;(D) The date the prescription was initially

filled and the date of each refill;(E) Patient’s full name, or if an animal, the

species and owner’s name;(F) Patient’s address or animal owner’s

address when a prescription prescribes a con-trolled substance;

(G) Prescriber’s full name;(H) Prescriber’s address and Drug Enforce-

ment Administration (DEA) number when aprescription specifies a controlled substance;

(I) Name, strength and dosage of drug,device or poison dispensed and any directionsfor use;

(J) Quantity originally dispensed;(K) Quantity dispensed on each refill;(L) Identity of the pharmacist responsible

for verifying the accuracy of prescription dataprior to dispensing on each original prescrip-tion;

(M) Identity of the pharmacist responsiblefor reviewing the final product prior to dis-pensing on each original and refill prescrip-tion, if different from the pharmacist verify-ing prescription data;

(N) The number of authorized refills andquantity remaining;

(O) Whether generic substitution has beenauthorized by the prescriber;

(P) The manner in which the prescriptionwas received by the pharmacy (e.g., written,telephone, electronic, or faxed); and

(Q) Any other change or alteration made inthe original prescription based on contact withthe prescriber to show a clear audit trail. Thisshall include, but is not limited to, a change inquantity, directions, number of refills, orauthority to substitute a drug.

(3) The information specified in section (2)shall be required and recorded in the EDPsystem prior to dispensing by a pharmacist orpharmacy.

(4) Except as otherwise provided by 20 CSR2220-2.083, prescription hard copies must bemaintained and filed by either the sequentialprescription label number or by a uniquereadily retrievable identifier. For verbal, tele-phone, or electronic data transmission pre-scriptions, a hard copy representation of theprescription shall be made and filed whichcontains all of the information in section (2).Prescription hard copies must be retrievableat the time of inspection, except as otherwiseprovided by 20 CSR 2220-2.010(1)(J). Forpurposes of this subsection an “electronicdata transmission prescription” shall bedefined as provided in 20 CSR 2220-2.085.

(5) If additional refills are authorized andadded to a prescription, a notation indicatingthe method and source of the authorizationmust be a part of the EDP record or hardcopy, in that case the expiration date of theoriginal prescription shall remain the same.

(6) Any hospital pharmacy using an EDP sys-tem licensed by the board, as described insection (1), for outpatient prescriptions,employee prescriptions, and take-home pre-scriptions shall conform to all sections of thisrule.

(7) Any EDP system must be capable of pro-ducing the record required by this rule andsaid records shall be readily retrievableonline. Readily retrievable is defined as pro-viding EDP records immediately or withintwo (2) hours of a request by an inspector orby making a computer terminal available tothe inspector for immediate use.

(8) An auxiliary record-keeping system shallbe established for the documentation of refillsif the EDP system is inoperative for any rea-

son. The auxiliary system shall ensure that allrefills are authorized by the original prescrip-tion or prescriber. When this EDP system isrestored to operation, the information regard-ing prescriptions filled and refilled during theinoperative period shall be entered into theEDP system within seven (7) working days.However, nothing in this section shall pre-clude the pharmacist from using his/her pro-fessional judgment for the benefit of apatient’s health and safety.

(9) If a prescription is transferred from apharmacy using an EDP system, a notation ordeactivation must be made on the transferredrecord to preclude any further dispensing. Ifthe same prescription is transferred back intothe original pharmacy, it shall be treated as anew record, showing the original date writtenand expiration date.

(10) Prior to or simultaneously with the purg-ing of any EDP system, the permit holdershall make certain that a record of all pre-scription activity being erased exists in read-able form, either on paper, microfiche, orelectronic media storage. A pharmacy thatdesires to discard hard copy prescriptions thatare more than three (3) years old must main-tain all prescription information on micro-fiche or electronic media. Any process utiliz-ing microfiche must ensure that all data isavailable and in readable form. Any pharma-cy opting for the utilization of microficherecords must also maintain a microfiche read-er so that records may be reviewed on-site bypharmacy personnel or board inspectors.Electronic media storage is defined as anymedium such as a computer, floppy disk ordiskette, compact disk (CD), or other elec-tronic device that can reproduce all prescrip-tion information as required by section338.100, RSMo, and this rule and is retriev-able within three (3) working days.

(11) If coded information exists in the elec-tronic EDP, the board inspector may requestthe definitions of the codes from the pharma-cist on duty for immediate review.

(12) The EDP system shall be able to providea listing of drug utilization for any drug for aminimum of the preceding twenty-four- (24-)month period. Drug utilization informationshall be available by date(s), specific drugproduct, patient name, or practitioner. Ifrequested to do so, the pharmacy shall havethree (3) working days to provide the report.

(13) The provisions of this rule shall not con-flict with any federal laws or regulations. Ifany part of this rule is declared invalid by acourt of law, that declaration shall not affectthe other parts of the rule.

(14) Licensees shall also comply with all state


Secretary of State




and federal controlled substance record keep-ing requirements, including, any requireddaily log books or printouts.

AUTHORITY: sections 338.100 and 338.140,RSMo Supp. 2012, and section 338.280,RSMo 2000.* This rule originally filed as 4CSR 220-2.080. Original rule filed March 8,1984, effective Aug. 11, 1984. Amended:Filed Nov. 4, 1985, effective Feb. 24, 1986.Rescinded and readopted: Filed Dec. 5,1988, effective March 11, 1989. Amended:Filed March 15, 2000, effective Sept. 30,2000. Amended: Filed Nov. 1, 2000, effectiveJune 30, 2001. Moved to 20 CSR 2220-2.080,effective Aug. 28, 2006. Amended: Filed Jan.10, 2013, effective Aug. 30, 2013.

*Original authority: 338.100, RSMo 1939, amended 1971,1990, 1997, 1999, 2010; 338.140, RSMo 1939, amended1981, 1989, 1997, 2011; and 338.280, RSMo 1951,amended 1971, 1981.

20 CSR 2220-2.083 Electronic Record-Keeping Systems

PURPOSE: The purpose of this rule is toestablish requirements and guidelines formaintaining prescription hard copies in anelectronic record-keeping system.

(1) In lieu of maintaining the original prescrip-tion hard copy or a hard copy representationas required by 20 CSR 2220-2.018 or 20 CSR2220-2.080, a pharmacy shall be authorized tomaintain an exact digitized image of the pre-scription in an electronic record-keeping sys-tem (ERS). For purposes of this rule, an elec-tronic record-keeping system is defined as asystem maintained by the pharmacy that pro-vides input, storage, processing, communica-tions, output, and control functions for digi-tized images of original prescriptions. Anyalterations to the digitized original prescrip-tion shall be documented as required by 20CSR 2220-2.018 or 20 CSR 2220-2.080, asapplicable.

(2) Controlled substance hard copy prescrip-tions shall be maintained as required byapplicable state and federal law.

(3) Digitized prescription images shall bereadily retrievable by the pharmacy. Readilyretrievable shall be defined as providingrecords immediately or within two (2) hoursof a request of the inspector or by making acomputer terminal available to the inspectorfor immediate use. An ERS system shall becapable of printing and retrieving the digi-tized prescription image at the time of inspec-tion, including the reverse side of the pre-

scription if applicable. Any printout of a dig-itized prescription image provided by alicensee/registrant to the patient or thepatient’s representative shall be conspicuous-ly marked with the statement “Copy Only –Not Valid for Dispensing Purposes.”

(4) Pharmacies maintaining an ERS shallestablish written policies and procedures forthe use of the ERS which shall include poli-cies and procedures for reviewing compliancewith the requirements of this rule and forstoring, retrieving, and recovering digitizedimages. The policy and procedure manualshall be reviewed annually and shall be avail-able to representatives of the board uponrequest.

(5) All digitized images in the ERS shall bestored, copied, or saved onto secure storagemedia on a regular basis in a manner that willallow image recovery in the event of a disas-ter, system interruption, or system failure.

AUTHORITY: sections 338.100 and 338.140,RSMo Supp. 2012.* Original rule filed Jan.10, 2013, effective Aug. 30, 2013.

*Original authority: 338.100, RSMo 1939, amended 1971,1990, 1997, 1999, 2010 and 338.140, RSMo 1939, amend-ed 1981, 1989, 1997, 2011.

20 CSR 2220-2.085 Electronic Prescrip-tions and Medication Orders

PURPOSE: This rule establishes guidelinesfor electronic prescriptions and medicationorders.

(1) Definitions.(A) Electronic image transmission—An

exact visual image of a paper prescription ormedication order that is electronicallyreceived by a pharmacy from a licensed pre-scriber or the prescriber’s authorized agent(e.g., a facsimile/scan).

(B) Electronic prescription—Any prescrip-tion or medication order, other than an elec-tronic image transmission, which is electron-ically transmitted from a licensed prescriberor the prescriber’s authorized agent to a phar-macy.

(C) Electronic signature—An exact elec-tronic replica of the prescriber’s signature ora confidential digital key code, number, orother identifier attached to or logically asso-ciated with a record that is executed or adopt-ed by a prescriber with the intent to sign therecord.

(2) Prescriptions or medication orders may betransmitted to a pharmacy by the prescriber

or the prescriber’s authorized agent as anelectronic image transmission or an electron-ic prescription.

(A) Electronic image transmissions andelectronic prescriptions must contain allinformation required by state and federal law,including, designation of whether genericsubstitution is authorized. Electronic imagetransmissions must be formatted as requiredby section 338.056, RSMo, and bear the pre-scriber’s manual or electronic signature.

(B) Controlled substance prescriptions andmedication orders must comply with stateand federal controlled substance laws andregulations and must be signed in accordancewith state and federal law.

(C) A pharmacist shall be responsible forverifying the authenticity of any electronicimage transmission or electronic prescriptionprior to dispensing by taking measureswhich, in his/her professional judgment, maybe necessary to ensure the prescription ormedication order was initiated or authorizedby the prescriber.

(3) In lieu of a manually signed prescriptionor medication order, a pharmacist may accepta paper prescription or medication order withan electronic signature if the prescription/med-ication order is applied to paper that utilizessecurity features that will detect or otherwiseidentify if the prescription/medication orderis subject to any form of copying and/or alter-ation.

AUTHORITY: sections 338.095, 338.140,and 338.280, RSMo 2016, and section338.010, RSMo Supp. 2017.* This rule origi-nally filed as 4 CSR 220-2.085. Original rulefiled Sept. 25, 1995, effective April 30, 1996.Amended: Filed July 28, 2000, effective Jan.30, 2001. Amended: Filed April 16, 2001,effective Nov. 30, 2001. Moved to 20 CSR2220-2.085, effective Aug. 28, 2006. Amend-ed: Filed Dec. 15, 2017, effective June 30,2018.

*Original authority: 338.010, RSMo 1939, amended 1951,1989, 1990, 2007, 2009, 2011, 2014, 2017; 338.095,RSMo 1993, 2007; 338.140, RSMo 1939, amended 1981,1989, 1997, 2011; and 328.280, RSMo 1951, amended1971, 1981.

20 CSR 2220-2.090 Pharmacist-in-Charge

PURPOSE: This rule defines the term phar-macist-in-charge, sets the requirements andstandards for this title, and defines the termfull-time pharmacy.

(1) A pharmacist may be a pharmacist-in-charge of a licensed pharmacy; provided, thats/he complies with all provisions of this rule.

(2) The responsibilities of a pharmacist-in-charge, at a minimum, will include:

(A) The management of the pharmacymust be under the supervision of a Missouri-licensed pharmacist at all times when pre-scriptions are being compounded, dispensedor sold;

(B) The traffic in the prescription areamust be restricted to authorized personnelonly so that proper control over the drugs canbe maintained at all times;

(C) All the required signs are displayed inthe appropriate places when there is no phar-macist on duty;

(D) The licenses of all pharmacistsemployed are conspicuously displayed in thepharmacy;

(E) Assurance that all procedures of thepharmacy in the handling, dispensing andrecordkeeping of controlled substances are incompliance with state and federal laws;

(F) Any excessive or suspicious requests,or both, for the dispensing of controlled sub-stances be verified prior to dispensing;

(G) All labeling requirements are compliedwith according to section 338.059, RSMo,federal laws where required and board regu-lations governing auxiliary labeling of drugsand devices;

(H) The prescription files are maintainedaccording to the requirements of this boardand the other state and federal controlled sub-stance laws and regulations;

(I) The Missouri Revised Negative DrugFormulary and state laws governing drug sub-stitution be complied with when generic sub-stitution takes place;

(J) If exempt narcotics are sold, completerecords be kept of all exempt narcotics in abound exempt narcotic register;

(K) If poisons are sold, the pharmacymaintain a poison register;

(L) The pharmacy maintain and have onfile at all times the required reference library;

(M) The pharmacy be kept in a clean andsanitary condition;

(N) The pharmacist-in-charge will beresponsible for the supervision of all pharma-cy personnel, to assure full compliance withthe pharmacy laws of Missouri;

(O) All Missouri and federal licenses arekept up-to-date;

(P) Policies and procedures are in force toinsure safety for the public concerning anyaction by pharmacy staff members or withinthe pharmacy physical plant;

(Q) All equipment, as prescribed throughregulation, is available and in good workingorder;

(R) Security is sufficient to insure the safe-ty and integrity of all legend drugs located inthe pharmacy;

(S) Any changes of the following areappropriately carried out:

1. Pharmacy permit transfer of any typeor manner;

2. Regulation requirements completedsatisfactorily when a change of pharmacist-in-charge occurs;

3. Change of pharmacist’s own addressas it appears on his/her license;

(T) When the board-recognized pharma-cist-in-charge is changed at that licensedfacility, an appropriate documented inventoryof controlled substances must be taken;

(U) Assure that the appropriate handlingand disposal of controlled substances is doneand verified through appropriate documenta-tion and when necessary that controlled sub-stances be disposed of through appropriateprocedures involving the Missouri Board ofPharmacy or the Bureau of Narcotics andDangerous Drugs;

(V) No outdated drugs are dispensed ormaintained within the active inventory of thepharmacy, including prescription and relatednonprescription items;

(W) Assure full compliance with all stateand federal drug laws and rules;

(X) Compliance with state and federalrequirements concerning drug samples;

(Y) Assure that all state and federal lawsconcerning drug distribution and control arecomplied with and that no violations occurthat would cause a drug or device or anycomponent thereof to become adulterated ormisbranded;

(Z) Maintain compliance with all state andfederal laws governing drug distributor activ-ities and assure that appropriate licensure asa drug distributor is secured if lawful thresh-olds for unlicensed drug distributions areexceeded;

(AA) Assure overall compliance with stateand federal patient counseling requirements;

(BB) Maintain a current list of all person-nel employed by the pharmacy as pharmacytechnicians. The list shall include the name,registration number or a copy of an applica-tion for registration that has been submittedto the board and a description of duties to beperformed by each person contained on thelist;

(CC) Maintain written standards settingout the responsibilities of registered pharma-cy technicians as well as the procedures andpolicies for supervision of registered pharma-cy technicians, as required by 4 CSR 220-2.700(1). Said standards shall be available tothe board and its designated personnel forinspection and/or approvals;

(DD) Any person other than a pharmacistor permit holder who has independent accessto legend drug stock on a routine basis in apharmacy shall be required to register withthe board as a pharmacy technician. Thedetermination of whether or not an individualmust register as a pharmacy technician willbe the responsibility of the pharmacist-in-charge; and

(EE) Maintain compliance of automateddispensing and storage systems with applica-ble board rules and regulations.

AUTHORITY: sections 338.140, 338.240 and338.280, RSMo 2000.* This rule originallyfiled as 4 CSR 220-2.090. Emergency rulefiled April 12, 1984, effective April 22, 1984,expired Aug. 20, 1984. Original rule filedApril 12, 1984, effective Aug. 11, 1984.Amended: Filed Feb. 25, 1986, effective Aug.11, 1986. Amended: Filed Jan. 27, 1995,effective Sept. 30, 1995. Amended: FiledAug. 21, 1998, effective Feb. 28, 1999.Amended: Filed Dec. 30, 1998, effective June30, 1999. Amended: Filed Nov. 1, 2000,effective June 30, 2001. Moved to 20 CSR2220-2.090, effective Aug. 28, 2006.

*Original authority: 338.140, RSMo 1939, amended 1981,1989, 1997; 338.240, RSMo 1951; and 338.280, RSMo1951, amended 1971, 1981.

20 CSR 2220-2.095 Collection of Medica-tion for Destruction

PURPOSE: The purpose of this rule is toauthorize pharmacies to collect medicationfor purposes of destruction and to establishrequirements for medication collection pro-grams.

(1) Missouri licensed pharmacies may collectmedication from the public for destruction incompliance with this rule. Pharmacies col-lecting controlled substances shall complywith all applicable state and federal con-trolled substance laws. Pharmacies collectingnon-controlled substances shall comply withsections (2) to (9) of this rule. Participation ina medication return or destruction program isvoluntary. This rule shall not be construed torequire that a licensee or permit holder par-ticipate in or establish a return/destruction


Secretary of State


program.

(2) Definitions. The following definitions shallapply for purposes of this rule:

(A) “Mail”- Mail shall include mailing viathe United States Postal Service or shippingvia a common carrier; and

(B) “Nonretrievable”- For the purposes ofdestruction, a condition or state to whichmedication is rendered after undergoing aprocess that permanently alters the medica-tion’s physical condition or state through irre-versible means and thereby renders the med-ication unavailable and unusable for allpractical purposes.

(3) Pharmacies may maintain a collectionreceptacle or establish an authorized mail-back program to collect non-controlled med-ication from the general public for destruc-tion. Collection receptacles may not be usedto dispose of unused/unwanted medication inthe pharmacy’s inventory (e.g., outdateddrugs, medical waste). Collected medicationshall not be resold or reused.

(A) Pharmacies collecting medicationunder this rule shall develop and implementwritten policies and procedures governingmedication collection which must include,but not be limited to, authorized destructionprocedures and methods.

(B) This rule does not preempt or modifyreturn/reuse of medication as authorized by20 CSR 2220-3.040, the provisions of Chap-ter 196, RSMo, governing the PrescriptionDrug Repository Program, or any provisionof state or federal law governing controlledsubstances or the destruction, handling, ortransporting of medical or pharmaceuticalwaste.

(4) Collection Receptacles. Pharmacies thatmaintain a collection receptacle to collectnon-controlled medication for destructionmust comply with the following:

(A) Collection receptacles must be secure-ly placed and maintained inside the physicalbuilding of the pharmacy in a manner thatprevents theft, diversion, or unauthorizedremoval. Receptacles must be securely fas-tened to a permanent structure. The recepta-cle must be visible to pharmacy staff at alltimes and shall not be located in or near exitdoors;

(B) The receptacle must be a securelylocked, substantially constructed containerwith a permanent outer container, and mustcontain an inner liner that complies with thisrule. The receptacle must have an openingthat allows medication to be added to theinner liner but does not allow the contents ofthe inner liner to be removed. The opening

must be locked or otherwise made inaccessi-ble to the public so that drugs cannot bedeposited into the collection receptacle whenthe pharmacy is closed for business;

(C) A sign must be prominently displayedon the outer container of the receptacle indi-cating that only non-controlled substancesmay be deposited into the receptacle. If thereceptacle is also used to collect controlledsubstances, the required sign must complywith state and federal controlled substancelaws;

(D) Inner liners must be removable, water-proof, tamper-evident, and tear-resistant andmust bear a permanent, unique identificationnumber or identifier that enables the innerliner to be tracked. The contents of the innerliner shall not be viewable from the outside;

(E) Inner liners must be installed orremoved from a collection receptacle by orunder the supervision of at least two (2)board licensees or registrants. Inner linersmust be immediately sealed once removedfrom the receptacle; the sealed inner linershall not be opened, x-rayed, analyzed, orotherwise penetrated by the pharmacy orpharmacy staff. After removal, sealed innerliners pending destruction may be stored atthe pharmacy in a securely locked, substan-tially constructed cabinet or in a securelylocked room or area with controlled accessfor no more than thirty (30) business days;and

(F) Pharmacies must report any theft ordiversion of or from a collection receptacle tothe board in writing within fourteen (14) daysin a manner designated by the board.

(5) Mail-Back Programs. Pharmacies mayprovide mail-back packages to the public forthe purpose of mailing medication to a collec-tor that is authorized by the Drug Enforce-ment Administration or federal law to receiveprescription medication for destruction (“anauthorized collector”). Packages may be pro-vided directly by the pharmacy or the phar-macy’s authorized designee, provided thepharmacy is responsible for ensuring compli-ance with this section.

(A) Mail-back packages must be pread-dressed with the address of the authorizedcollector. The cost of shipping the packageshall be postage or otherwise prepaid.Licensees/permit holders shall not accept anyreturned mail-back packages. Packages mustbe mailed directly to the authorized collectorby the consumer or his/her agent.

(B) Mail-back packages must be nonde-script and shall not include any markings orother information that might indicate that thepackage contains medication. Packages mustbe water-proof, spill-proof, tamper-evident,

tear-resistant, and sealable.(C) Mail-back packages must be provided

with instructions for mailing, notice thatpackages may only be mailed from within thefifty (50) United States or US territories, andnotice that only packages provided by or onbehalf of the pharmacy may be used to mailmedication.

(D) Senders shall not be required to pro-vide any personally identifiable informationwhen mailing back medication.

(E) Mail-back packages must include aunique identification number or other uniqueidentifier that enables the package to betracked.

(6) Long-Term Care Facilities. Pharmaciesmay provide and maintain a collection recep-tacle at a long-term care facility to collectmedication from the public or facility resi-dents for destruction. This section does notapply to medication collected for return andreuse as authorized by 20 CSR 2220-3.040.

(A) Collection receptacles must be secure-ly placed and maintained inside the physicalbuilding of the long-term care facility in amanner that prevents theft, diversion, orunauthorized removal. Receptacles must besecurely fastened to a permanent structureand must be visible to the facility’s staff at alltimes. In lieu of fastening to a permanentstructure, receptacles that are not accessibleto the public or residents may be stored in asecurely locked room or area with controlledaccess that is restricted to facility staff/per-sonnel until transfer to the pharmacy. Collec-tion receptacles shall not be located in or nearexit doors.

(B) Collection receptacles must be a secure-ly locked, substantially constructed containerwith a permanent outer container, and mustcontain an inner liner that complies with sub-sections (4)(D) and (E) of this rule. The recep-tacle must have an opening that allows medica-tion to be added to the inner liner but does notallow the contents of the inner liner to beremoved. The opening must be locked or oth-erwise made inaccessible to the public so thatdrugs cannot be deposited into the collectionreceptacle when the facility is closed for busi-ness.

(C) If the receptacle is accessible to thepublic or residents, a sign must be prominent-ly displayed on the outer container of thereceptacle indicating that only non-controlledsubstances may be deposited into the recepta-cle. The required sign must comply with stateand federal controlled substance laws if thereceptacle is also used to collect controlledsubstances.

(D) The pharmacy shall be responsible forinstalling, managing, and maintaining the



receptacle and for the removal, sealing, trans-fer, and storage of inner liners and receptaclecontents.

(E) Inner liners may only be installed,removed, and transferred either: 1) by orunder the supervision of two (2) boardlicensees or registrants acting on behalf of thepharmacy; or 2) by or under the supervisionof a board licensee/registrant and an employ-ee/staff member of the long-term care facilitydesignated by the pharmacy (e.g., a supervi-sory charge nurse).

(F) After removal, sealed inner liners maybe stored at the facility in a securely locked,substantially constructed cabinet or in asecurely locked room or area with controlledaccess for no more than three (3) businessdays.

(7) Destruction Methods. Medication collect-ed for destruction shall be rendered nonre-trievable and destroyed in compliance with allapplicable federal and state laws. Medicationshall be destroyed in one (1) of the followingways:

(A) On-site Destruction: Medication maybe destroyed on the physical premises of thepharmacy, provided two (2) board licenseesor registrants must personally witness thedestruction of the medication and handle orobserve the handling of the medication untilthe substance is rendered non-retrievable; or

(B) Transfer to an Authorized Entity: Col-lected medication may be mailed, shipped, ortransferred to an entity authorized to destroythe medication off-site, provided two (2)board licensees or registrants must witness orobserve the mailing, shipping, or transfer. Ifmedication is transported by the pharmacy tothe off-site location, the medication must beconstantly moving towards its final location.Unnecessary and unrelated stops and stops ofan extended duration shall not occur.

(8) Records. Except as otherwise providedherein, pharmacies shall maintain a completeand accurate record of the following for two(2) years:

(A) Inventories. Pharmacies shall conductan inventory every twelve (12) months ofinner-liners that are present at the pharmacyor at a long-term care facility that are unusedor awaiting destruction. The inventory shallbe documented in writing and must include:

1. The date of the inventory;2. The number of inner liners present on

the date of the inventory and the size of anyinner liners (e.g., five (5) ten- (10-) gallonliners, etc.);

3. The unique identificationnumber/identifier of each inner liner,whether unused or awaiting destruction;

(B) Inner Liners. The pharmacy must

maintain the following written records forinner liners:

1. The unique identificationnumber/identifier and the size of each unusedinner liner (e.g., five- (5-) gallon, ten- (10-)gallon, etc.);

2. The date each inner liner is installed,the address of the location where each liner isinstalled, the unique identificationnumber/identifier and size of each installedinner liner, and the names and signatures ofthe two (2) required witnesses for each instal-lation; and

3. The date each inner liner is removedand sealed, the unique identification num-ber/identifier of each removed inner liner,and the names and signatures of the two (2)required witnesses for each removal; and

(C) Destruction. The pharmacy mustmaintain the following written records:

1. For medication destroyed on-site ofthe pharmacy, the date and method ofdestruction, the unique identification num-ber/identifier of each inner liner destroyed,and the names and signatures of the two (2)required witnesses of the destruction.

2. For medication destroyed off-site, thedate each inner liner was transferred fordestruction, the name and address of eachentity to whom each sealed inner liner wastransferred for destruction, the unique identi-fication number/identifier of each inner linertransferred for destruction, and the name ofthe two (2) required witnesses for medicationtransfer or transport.

(9) Law Enforcement Return Programs.Licensees/permitholders shall be exemptfrom compliance with this rule when partici-pating in medication collection programsconducted by local, state, or federal lawenforcement agencies provided—

(A) Collected medication is placed into acollection container or area that is under thesupervision of law enforcement personnel atall times;

(B) Law enforcement personnel are presentwhenever drugs are collected or on-site; and

(C) The licensee/permitholder does nottake possession of the collected medications.Collected medications must remain under thecontrol of, and must be removed by, lawenforcement.

AUTHORITY: sections 338.140, 338.240,338.280, and 338.315, RSMo 2016.* Origi-nal rule filed Aug. 30, 2016, effective March30, 2017.

*Original authority: 338.140, RSMo 1939, amended 1981,1989, 1997, 2011; 338.240, RSMo 1951, amended 2011;338.280, RSMo 1951, amended 1971, 1981; and 338.315,RSMo 1989, amended 2011, 2012, 2014.

20 CSR 2220-2.100 Continuing PharmacyEducation(Rescinded August 30, 2013)

AUTHORITY: sections 338.060 and 338.140,RSMo 2000. This rule originally filed as 4CSR 220-2.100. Original rule filed Nov. 9,1984, effective April 11, 1985. Amended:Filed Nov. 21, 1997, effective June 30, 1998.Amended: Filed March 15, 2000, effectiveSept. 30, 2000. Amended: Filed June 28,2002, effective Jan. 30, 2003. Amended:Filed April 1, 2004, effective Sept. 30, 2004.Amended: Filed June 15, 2005, effective Jan.30, 2006. Moved to 20 CSR 2220-2.100,effective Aug. 28, 2006. Rescinded: FiledJan. 10, 2013, effective Aug. 30, 2013.

20 CSR 2220-2.110 PRN Refills

PURPOSE: This rule clarifies the board’srequirements for refills as needed so that thepracticing pharmacists in Missouri will haveadequate guidelines in this area.

(1) A pharmacist shall not fill or refill anyprescription which was written more than one(1) year before being presented to the phar-macist, unless the pharmacist consults withthe prescriber and confirms—

(A) That the person for whom the drugs ormedicines were prescribed is still under theprescriber’s care or treatment;

(B) That the prescriber desires for the per-son to continue receiving the drugs or medi-cines; or

(C) If the prescriber answers negatively ineither case listed in subsection (1)(A) or(B), the pharmacist shall not fill or refill theprescription, even if the prescription autho-rizes refills as needed (PRN).

(2) If a pharmacist knows or has reason tobelieve that a person for whom a prescriptionhas been written is not under the prescriberscare or treatment at the time the prescriptionis presented for filling or refilling, the phar-macist shall consult with their prescriber andascertain that the prescriber intends for theperson to receive the drugs or medicines. Thepharmacist shall do this no matter when theprescription originally was written and evenif the prescription authorizes refills PRN.

(3) After the pharmacist has confirmed theinformation required in sections (1) and (2) ofthis rule, s/he shall record it in his/herrecords in a uniform fashion so as to make itreadily available for verification by the boardor its authorized agents.

AUTHORITY: section 338.280, RSMo 1994.*This rule originally filed as 4 CSR 220-2.110.


Secretary of State


Original rule filed Dec. 11, 1984, effectiveMarch 11, 1985. Moved to 20 CSR 2220-2.110, effective Aug. 28, 2006.

*Original authority: 338.280, RSMo 1951, amended 1971,1981.

20 CSR 2220-2.120 Transfer of Prescrip-tion Information for the Purpose of Refill

PURPOSE: This rule defines record keepingrequired for transfer of prescription informa-tion for the purpose of refill.

(1) Prescription information shall be trans-ferred for the purposes of refill betweenlicensed pharmacies, provided the prescriptioninformation to be transferred meets all of thefollowing criteria:

(A) The prescription information indicatesauthorization by the prescriber for refilling;

(B) The drug on the prescription informa-tion is not a Schedule II controlled substance;

(C) The number of lawfully allowablerefills has not been exceeded or the maximumallowable time limit has not been exceeded;

(D) If the transfer involves a controlledsubstance, all information must be trans-ferred directly between two (2) licensed phar-macists; and

(E) The transfer of original prescriptioninformation for a controlled substance listedin Schedules III, IV or V for the purpose ofrefill dispensing is permissible between phar-macies on a one (1)-time basis only. Howev-er, pharmacies electronically sharing a real-time, online database may transfer up to themaximum refills permitted by law and theprescriber’s authorization.

(2) When a prescription on record is trans-ferred, the following record keeping isrequired:

(A) The prescription record at the transfer-ring pharmacy shall show all of the following:

1. The word void must appear on theface of the invalidated prescription or beimmediately voided within the electronic sys-tem when the prescription is transferred;

2. The prescription record shall providethe name of the pharmacy to which it wastransferred, the date of transfer and the iden-tity of the transferring pharmacist; and

3. If the transfer involves a controlledsubstance, the address and Drug EnforcementAdministration (DEA) registration number ofthe pharmacy to which it was transferred andthe full name of the pharmacist receiving theprescription information must be recorded;

(B) The prescription record at the receiv-ing pharmacy shall show all of the following,in addition to all other lawfully required

information of an original prescription:1. The prescription record is a trans-

ferred prescription record from anotherlicensed location;

2. Date of original issuance;3. Date of original filling, if different

from original issuance date;4. Original number of refills authorized

on the original prescription and the numberof remaining authorized refills;

5. Date of last refill;6. Prescription label number;7. Identity of licensed pharmacy from

which the record was transferred;8. The identity of the transferring phar-

macist provided that pharmacies that sharethe same database and are under the sameownership may, instead of transferring pre-scriptions directly between two (2) pharma-cists, transfer a prescription electronically bygenerating a computer-based report at thetransferring pharmacy of any prescriptionsthat have been transferred out. This recordshall be readily retrievable to the transferringpharmacy and board representatives and com-ply with all of the requirements of this rule,except that the requirement to documentpharmacist identity shall not be requiredunless otherwise required by federal law;

9. If the transfer involves a controlledsubstance, the address and DEA registrationnumber from the transferring pharmacy mustbe recorded; and

10. Any electronic transfer must main-tain patient confidentiality in accordance with20 CSR 2220-2.300; and

(C) A computerized transfer of prescrip-tion information between licensed pharma-cies for the purpose of refill shall meet all therequirements stated in sections (1) and (2) ofthis rule.

(3) A pharmacy shall complete the transferwithin one (1) business day of receiving therequest.

AUTHORITY: sections 338.100, 338.140,and 338.280, RSMo 2000.* This rule origi-nally filed as 4 CSR 220-2.120. Original rulefiled April 16, 1985, effective Aug. 11, 1985.Amended: Filed May 2, 1989, effective Aug.24, 1989. Amended: Filed April 23, 1998,effective Nov. 30, 1998. Amended: Filed July28, 2000, effective Jan. 30, 2001. Moved to20 CSR 2220-2.120, effective Aug. 28, 2006.Amended: Filed Feb. 6, 2008, effective Aug.30, 2008.

*Original authority: 338.100, RSMo 1939, amended 1971,1990, 1997, 1999; 338.140, RSMo 1939, amended 1981,1989, 1997; and 338.280, RSMo 1951, amended 1971,1981.

20 CSR 2220-2.130 Drug Repackaging

PURPOSE: This rule establishes require-ments for drug repackaging.

PUBLISHER’S NOTE: The secretary of statehas determined that the publication of theentire text of the material which is incorpo-rated by reference as a portion of this rulewould be unduly cumbersome or expensive.Therefore, the material which is so incorpo-rated is on file with the agency who filed thisrule, and with the Office of the Secretary ofState. Any interested person may view thismaterial at either agency’s headquarters orthe same will be made available at the Officeof the Secretary of State at a cost not toexceed actual cost of copy reproduction. Theentire text of the rule is printed here. Thisnote refers only to the incorporated by refer-ence material.

(1) A pharmacist or pharmacy may prepack-age drugs for other than immediate dispens-ing purposes provided that the following con-ditions are met:

(A) Only products which will be directlyprovided to the patient may be prepackaged;

(B) Containers utilized for prepackagingshall meet, as a minimum requirement, thatof Class B container standards as referencedby the United States Pharmacopoeia (USP),which has been incorporated herein by refer-ence. Where applicable, light sensitive con-tainers shall be used;

(C) The maximum expiration date allowedfor prepacked drugs shall be the manufactur-er’s expiration date or twelve (12) months,whichever is less; and

(D) Any prepacked drug must have a labelaffixed to it which contains, at a minimum,the name and strength of the drug, the nameof the manufacturer or distributor, an expira-tion date as defined in subsection (1)(C) andlot number. Pharmacies that store drugs with-in an automated counting device may, inplace of the required label, maintain recordsfor lot numbers and expiration dates that arerequired on the label as long as it is fullytraceable and is readily retrievable during aninspection.

(2) The term prepacked as used in this rule isdefined as any drug which has been removedfrom the original manufacturer’s containerand is placed in a dispensing container forother than immediate dispensing to a patient.

AUTHORITY: sections 338.140 and 338.280,RSMo 2000.* This rule originally filed as 4CSR 220-2.130. Original rule filed Dec. 10,1986, effective May 28, 1987. Amended:Filed Nov. 15, 1988, effective March 11,



1989. Emergency amendment filed July 1,1991, effective July 26, 1991, expired Nov.22, 1991. Amended: Filed July 1, 1991, effec-tive Jan. 13, 1992. Amended: Filed July 28,2000, effective Jan. 30, 2001. Amended:Filed Jan. 31, 2003, effective Aug. 30, 2003.Moved to 20 CSR 2220-2.130, effective Aug.28, 2006.

*Original authority: 338.140, RSMo 1939, amended 1981,1989, 1997 and 338.280, RSMo 1951, amended 1971,1981.

20 CSR 2220-2.140 Prescription Servicesby Pharmacists/Pharmacies for Residentsin Long-Term Care Facilities

PURPOSE: This rule establishes standardsfor pharmacists providing prescription ser-vices to residents in long-term care facilities.The standards are directed to licensed phar-macists and pharmacies, and not to long-termcare facilities.

PUBLISHER’S NOTE: The secretary of statehas determined that the publication of theentire text of the material which is incorpo-rated by reference as a portion of this rulewould be unduly cumbersome or expensive.Therefore, the material which is so incorpo-rated is on file with the agency who filed thisrule, and with the Office of the Secretary ofState. Any interested person may view thismaterial at either agency’s headquarters orthe same will be made available at the Officeof the Secretary of State at a cost not toexceed actual cost of copy reproduction. Theentire text of the rule is printed here. Thisnote refers only to the incorporated by refer-ence material.

(1) Licensure. A pharmacist who or pharma-cy which provides prescription services to along-term care facility must be licensed topractice pharmacy in this state. A long-termcare facility means a nursing home, retire-ment care, mental care or other facility orinstitution which provides extended healthcare to resident patients.

(2) Medication Services.(A) Policies and procedures shall be for-

mulated to cover all packaging and dispensingresponsibilities of the pharmacist/pharmacyto the residents of the long-term care facilityand shall include, at a minimum:

1. Methods used to dispense medica-tions in a timely fashion to the facility;

2. Proper notification to the facilitywhen a medication is not readily available;

3. Proper labeling requirements to meetthe needs of the facility and which are consis-

tent with state and federal laws; and4. Appropriate medication destruction,

return of unused medication, or both, whichis consistent with state and federal laws.

(B) Container labeling, at all times, shallconform to Chapter 338, RSMo. If a labelchange is required to reflect a change indirections, the pharmacist personally shallaffix the correct label to the container. How-ever, direction change labels which aredefined as indicator labels that notify long-term care facility personnel that a change indirections for medication has taken place,may be used and affixed to the container bynursing home personnel in a way as not todeface the original label. Labeling of unitdose packages may be distinguished from therequirements as set forth in section 338.059,RSMo by insuring that the drug name andstrength, control number and expiration dateand manufacturer’s name appear on the pack-age itself. A patient’s name and directionsmay not have to appear directly on the med-ication container but a mechanism shouldexist to identify for the personnel administer-ing medications, what medications eachpatient is to receive and the directions foradministration.

(C) All prescription containers, including,but not limited to, single unit, unit dose andunit-of-use containers utilized for distributionwithin a long-term care facility shall meetminimum requirements as referenced by theUnited States Pharmacopoeia (USP) which isincorporated herein by reference. Whereapplicable, light-sensitive packaging shall beused.

(3) Any drug, repackaged or prepacked thatis dispensed into a long-term care facility, asdefined in section (1) of this rule, in otherthan the manufacturer’s original container,shall bear the manufacturer’s expiration dateor twelve (12) months, whichever is less.

(4) Remote dispensing systems are defined asany system of an automated or manual designthat is used to provide doses of medication topatients for the immediate administration byauthorized health care personnel and is notlicensed under Chapter 338, RSMo as a phar-macy. Any medication obtained in excessiveamounts shall constitute the practice of phar-macy and will require adherence to all applic-able licensure and drug laws.

(A) If personnel other than a pharmacistrestocks a remote dispensing system, thenany drugs or other items that are to be placedwithin a remote dispensing system must bechecked and approved by a licensed pharma-cist.

(B) Any products that are repackaged for

use in a remote dispensing system must com-ply with all provisions of 4 CSR 220-2.130.

(C) Appropriate security must be main-tained over any remote dispensing system andthere must be policies and procedures utilizedin the delivery and storage of drugs anddevices that deter misuse or theft.

(5) A prescription drug order is defined forthe purpose of this rule as an order originat-ing from a long-term care facility that is ini-tiated by a prescriber and entered into thepatient’s medical record by the prescriber orqualified personnel for the purpose of initiat-ing or renewing an order for a medication ordevice. All prescription drug orders shallcomply with 4 CSR 220-2.018.

(A) A prescription drug order may betransferred to a licensed pharmacy for thepurpose of providing an order to prepare,compound or dispense a medication or forthe purpose of providing drug or medicalinformation for use by the pharmacist in pro-viding patient care services.

(B) In order for a generic substitution asdefined in section 338.056, RSMo to takeplace, a prescription drug order must eithercomply with the prescription form as definedin section 338.056.2(1), RSMo or providean alternate method for documenting whethera generic substitution has been authorized asdetermined by the long-term care medicalstaff. When a generic substitution is autho-rized and is executed by the pharmacist aclear documentation must be completed inaccordance with 4 CSR 220-2.018(1)(H) and4 CSR 220-2.080(2)(M).

(C) A pharmacy may elect to maintain aseparate file system for prescription drugorders that are dispensed. When a separatefile is utilized, it must comply with all applic-able laws governing the maintenance and useof a prescription file by a pharmacy and thenumbering system used to number prescrip-tion drug orders must be distinct from anyother prescription file that is maintained.

(D) Packaging and labeling of containersshall comply with all applicable state and fed-eral laws for any medications that leave thefacility or are provided to the patient by thepharmacy for use outside the facility. Pre-scription drug orders issued for use withinthe long-term care facility are not valid forrefill outside the facility.

(6) Nothing in this rule shall be deemed toconstitute a waiver or abrogation of any of theprovisions of Chapter 338, RSMo or otherapplicable provisions of state and federal lawsand rules, nor should this rule be construedas authorizing or permitting any person not


Secretary of State


licensed as a pharmacist to engage in thepractice of pharmacy.

(7) The provisions of this rule are declaredseverable. If any portion of this rule is heldinvalid by a court of competent jurisdiction,the remaining provisions of this rule shallremain in full force and effect unless other-wise determined by the court.

AUTHORITY: sections 338.010, 338.210,338.240 and 338.280, RSMo 1994 and338.140, RSMo Supp. 1999.* This rule orig-inally filed as 4 CSR 220-2.140. Originalrule filed Oct. 16, 1987, effective March 25,1988. Amended: Filed July 5, 1988, effectiveMarch 1, 1989. Amended: Filed July 19,1991, effective Jan. 13, 1992. Amended:Filed Jan. 27, 1995, effective Sept. 30, 1995.Amended: Filed July 28, 2000, effective Jan.30, 2001. Moved to 20 CSR 2220-2.140,effective Aug. 28, 2006.

*Original authority: 338.010, RSMo 1939, amended 1951,1989, 1990; 338.140, RSMo 1939, amended 1981, 1989,1997; 338.210, RSMo 1951; 338.240, RSMo 1951; and338.280, RSMo 1951, amended 1971, 1981.

20 CSR 2220-2.145 Minimum Standardsfor Multi-Med Dispensing

PURPOSE: This rule establishes standardsfor multi-med dispensing.

(1) In lieu of dispensing two (2) or more pre-scribed drug products in separate containers,a pharmacist may, with the consent of thepatient, the patient’s caregiver, or a pre-scriber, provide a customized patient medica-tion package (patient med pak).

(2) A patient med pak is a package preparedby a pharmacist for a specific patient com-prising one (1) or more containers and con-taining two (2) or more prescribed solid oraldosage forms. The patient med pak is sodesigned or each container is so labeled as toindicate the day and time, or period of time,that the contents within each container are tobe taken.

(A) The patient med pak shall bear a labelstating—

1. The name of the patient;2. A serial number for the patient med

pak itself and a separate identifying serialnumber for each of the prescription orders foreach of the drug products contained therein;

3. The name, strength, physical descrip-tion or identification and total quantity ofeach drug product contained therein;

4. The directions for use and cautionarystatements if any, contained in the prescrip-tion order for each drug product therein;

5. Any storage instructions or caution-

ary statements required by the official com-pendia;

6. The name of the prescriber of eachdrug product;

7. The date of preparation of the patientmed pak and the beyond-use date assigned tothe patient med pak (such beyond-use dateshall be not later than sixty (60) days fromthe date of preparation);

8. The name, address, and telephonenumber of the dispenser; and

9. Any other information, statements, orwarnings required for any of the drug prod-ucts contained therein.

(B) If the patient med pak allows for theremoval or separation of the intact containerstherefrom, each individual container shallbear a label identifying each of the drug prod-ucts contained therein.

(C) The patient med pak shall be accompa-nied by a patient package insert, in the eventthat any medication therein is required to bedispensed with such insert as accompanyinglabeling. Alternatively, such required infor-mation may be incorporated into a single,overall, educational insert provided by thepharmacist for the total patient med pak.

(D) In the absence of more stringent pack-aging requirements for any of the drug prod-ucts contained therein, each container of thepatient med pak shall comply with the mois-ture permeation requirements for a Class Bsingle-unit or unit-dose container. Each con-tainer shall be either not reclosable or sodesigned as to show evidence of having beenopened.

(E) It is the responsibility of the dispenser,when preparing a patient med pak, to takeinto account any applicable compendiarequirements or guidelines and the physicaland chemical compatibility of the dosageforms placed within each container, as well asany therapeutic incompatibilities that mayattend the simultaneous administration of themedications. In this regard, pharmacists areencouraged to report to United States Phar-macopeia (USP) headquarters any observedor reported incompatibilities.

(F) In addition to any individual prescrip-tion filing requirements, a record of eachpatient med pak shall be made and filed.Each record shall contain, at a minimum:

1. The name and address of the patient;2. The serial number of the prescription

order for each drug product contained there-in;

3. The name of the manufacturer orlabeler and lot number for each drug productcontained therein;

4. Information identifying or describingthe design, characteristics, or specificationsof the patient med pak sufficient to allow sub-sequent preparation of an identical patientmed pak for the patient;

5. The date of preparation of the patientmed pak and the beyond-use date that wasassigned;

6. Any special labeling instructions; and7. The name or initials of the pharmacist

who prepared the patient med pak.(G) There is no special exemption for

patient med paks from the requirements ofthe Poison Prevention Packaging Act. Thusthe patient med pak, if it does not meet child-resistant standards, shall be placed in anouter package that does comply, or the neces-sary consent of the purchaser or physician todispense in a container not intended to bechild-resistant, shall be obtained.

(H) Once a patient med pak has been deliv-ered to an institution or to a patient it shallnot be returned to the pharmacy, unless thefollowing requirements are met:

1. The med pak is returned to the phar-macy from which it was originally dispensed;

2. The med pak is modified/repackaged,per prescription order, for the same patient towhom it was originally dispensed;

3. The med pak is labeled in compliancewith the requirements of this rule, providedthe med pak shall retain the original beyond-use date assigned to the med pak before mod-ification/repackaging;

4. The med pak is assigned a new serialnumber;

5. The medications removed from themed pak are destroyed in compliance withstate and federal law. In no event shall med-ication removed from a med pak be returnedto stock/inventory or dispensed to anotherpatient; and

6. Licensees shall comply with allapplicable record-keeping requirements.

(I) Multi-med packaging of controlled sub-stances is prohibited.

(J) Except as otherwise allowed in subsec-tion (H) of this section, once a drug has beencommingled with other drugs in a med pakthe drug may not be returned to stock, dis-pensed, or distributed except for destructionpurposes.

AUTHORITY: sections 338.010 and 338.140,RSMo Supp. 2011, and section 338.059,RSMo 2000.* This rule originally filed as 4CSR 220-2.145. Original rule filed March15, 2000, effective Sept. 30, 2000. Moved to20 CSR 2220-2.145, effective Aug. 28, 2006.Amended: Filed Jan. 3, 2012, effective June30, 2012.

*Original authority: 338.010, RSMo 1939, amended 1951,1989, 1990, 2007, 2009, 2011; 338.059, RSMo 1971,amended 1973, 1978, 1997; and 338.140, RSMo 1939,amended 1981, 1989, 1997, 2011.



20 CSR 2220-2.150 Mandatory ReportingRule

PURPOSE: This rule defines the responsibil-ities of a director of pharmacy or the pharma-cist-in-charge, or both, in a hospital orambulatory surgical center in reporting disci-plinary actions against pharmacist employeesto the chief executive officer of the employinginstitution.

(1) The board of pharmacy shall receive andprocess any report from a hospital or ambu-latory surgical center concerning any disci-plining action against a licensed pharmacistor the voluntary resignation of any licensedpharmacist against whom any complaints orreports have been made which might have ledto final disciplinary action.

(2) Reports to the board shall comply withthe minimum requirements as set forth in sec-tion 383.133, RSMo and this rule. This infor-mation shall include, but not be limited to:

(A) The name, address and telephone num-ber of the person making the report;

(B) The name, address and telephone num-ber of the person who is the subject of thereport;

(C) A brief description of the facts whichgave rise to the issuance of the report, includ-ing the dates of occurrence deemed to neces-sitate the filing of the report;

(D) If court action is involved and knownto the reporting agent, the identity of thecourt, including the date of filing and thedocket number of the action;

(E) A statement as to what final action wastaken by the institution; and

(F) That the report is being submitted inorder to comply with the reporting provisionsof Chapter 383, RSMo.

(3) The director of pharmacy or pharmacist-in-charge shall report any actions asdescribed in section (1) to the chief executiveofficer (CEO) or his/her designee. Any activ-ity that is construed to be a cause for discipli-nary action according to section 338.055,RSMo or results in potential or actual harmto the public shall be deemed reportable tothe board. Nothing in this rule shall be con-strued as limiting or prohibiting any pharma-cist from reporting a violation of the Pharma-cy Practice Act directly to the Missouri Boardof Pharmacy.

(4) In response to an inquiry from a hospitalor ambulatory surgical center regardingreports received by the board on a specificpharmacist, the board shall provide the fol-lowing information:

(A) Whether any reports have beenreceived;

(B) The nature of each report; and

(C) The action which the board took oneach report or if the board has taken actionon the report.

(5) Each report received shall be acknowl-edged in writing. The acknowledgment shallstate that the report is being reviewed by theboard or is being investigated and shall bereferred to the board or an appropriate boardsubcommittee for consideration. The institu-tion subsequently shall be informed in writ-ing as to whether the report has been dis-missed by the board or is being referred tolegal counsel for filing with the Administra-tive Hearing Commission or for other legalaction. The institution may be notified of theultimate disposition of the report excludingjudicial appeals and may be provided with acopy of the decisions (if any) of the Adminis-trative Hearing Commission and the board.

(6) The provisions of this rule are declaredseverable. If any portion of this rule is heldinvalid by a court of competent jurisdiction,the remaining provisions of this rule shallremain in full force and effect, unless other-wise determined by a count of competentjurisdiction.

AUTHORITY: sections 338.140, RSMo Supp.1989 and 383.133, RSMo 1986.* This ruleoriginally filed as 4 CSR 220-2.150. Originalrule filed Aug. 4, 1987, effective Jan. 29,1988. Moved to 20 CSR 2220-2.150, effectiveAug. 28, 2006.

*Original authority: 338.140, RSMo 1939, amended 1981,1989 and 383.133, RSMo 1986.

20 CSR 2220-2.160 Definition of Discipli-nary Actions

PURPOSE: This rule defines disciplinaryactions which may be imposed by the Mis-souri Board of Pharmacy.

(1) The Missouri Board of Pharmacy maypublish or cause to be published all disci-plines of certificates of registration or licens-es or both, including the name of thelicensee, the license number, the terms of dis-cipline and a summary of the Findings of Factand Conclusions of Law of the AdministrativeHearing Commission, in any professionaljournal or newsletter read by licensed phar-macists practicing in Missouri or in anynewspaper of general circulation or both.

(2) The Missouri Board of Pharmacy maypublicize the terms of disciplinary agree-ments, including the name of the licensee, thelicense number and a summary of the com-plaint, in any professional journal or newslet-ter read by licensed pharmacists practicing in

Missouri or in any newspaper of general cir-culation.

(3) Any licensee whose certificate of registra-tion, license to practice pharmacy, or both,has been revoked or suspended shall—

(A) Surrender his/her certificate of regis-tration or license, or both, to the MissouriBoard of Pharmacy to be held by the Mis-souri Board of Pharmacy for the duration ofthe suspension period;

(B) Refrain from misrepresenting the statusof his/her license to practice pharmacy to anypatient or to the general public; and

(C) Refrain from maintaining a physicalpresence in any location which is licensed asa pharmacy in Missouri during the period ofsuspension, except as a customer.

(4) The Missouri Board of Pharmacy mayimpose any other terms or requirementswhich, in its discretion, it may deem neces-sary to enforce an order of discipline.

(5) Any violation of a disciplinary order shallconstitute grounds for the Missouri Board ofPharmacy to impose further discipline orterms on the licensee’s certificate of registra-tion, license to practice pharmacy, or both.

(6) Any violation of a disciplinary agreementshall constitute grounds for the MissouriBoard of Pharmacy to impose a further peri-od of discipline unless the disciplinary agree-ment provides otherwise.

(7) If at any time when any disciplinary sanc-tions have been imposed under section338.055, RSMo or under any provision, thelicensee removes him/herself from Missouri,ceases to be currently licensed under the pro-visions of sections 338.010–338.310, RSMoor fails to keep the Missouri Board of Phar-macy advised of his/her current place ofemployment and residence, the time ofhis/her absence or unlicensed status or un-known whereabouts may, at the discretion ofthe board, not be deemed or taken as any partof the time of discipline so imposed.

(8) The provisions of this rule are declaredseverable. If any portion of this rule is heldinvalid by a court of competent jurisdiction,the remaining provisions of this rule shallremain in full force and effect, unless other-wise determined by a court of competentjurisdiction.

AUTHORITY: sections 338.140, RSMo Supp.1998 and 338.280, RSMo 1994.* This ruleoriginally filed as 4 CSR 220-2.160. Originalrule filed Oct. 1, 1987, effective March 11,1988. Amended: Filed June 29, 1999, effec-tive Jan. 30, 2000. Moved to 20 CSR 2220-2.160, effective Aug. 28, 2006.


Secretary of State


*Original authority: 338.140, RSMo 1939, amended 1981,1986 and 338.280, RSMo 1951, amended 1971, 1981.

20 CSR 2220-2.165 Licensure DisciplinaryAgreements

PURPOSE: This rule establishes guidelinesto be used by the board for licensure discipli-nary agreements.

(1) The board may elect to enter into anagreement for discipline with the holder of apharmacist or pharmacy license for the pur-pose of informally resolving a complaintwhich the board has prepared.

(2) The use of licensure disciplinary agree-ments shall be subject to the following:

(A) Agreements of this type will be used atthe option of the board and shall not bar theboard from filing any complaints with theAdministrative Hearing Commission in orderto seek disciplinary action for any violationof Chapter 338, RSMo;

(B) All licensure disciplinary agreementsshall contain a public notice clause whichprovides that the board will publish thelicensing action in its quarterly newsletterand shall treat the information contained inthe agreement as public information;

(C) When entering into a licensure disci-plinary agreement, the board and thelicensee shall waive any rights attendant to ahearing before the Administrative HearingCommission and will consent that the licen-sure disciplinary agreement is in lieu of pro-ceedings before the Administrative HearingCommission; and

(D) If the board determines that a licenseehas violated a term or condition of the agree-ment, or has otherwise failed to comply withthe provisions of Chapter 338, RSMo, whichviolation would be actionable in a proceedingbefore the State Board of Pharmacy, theAdministrative Hearing Commission, or in acircuit court, the board may elect to pursueany lawful remedies or procedures affordedto it.

(3) The provisions of this rule are declaredseverable. If any portion of this rule is heldinvalid by a court of competent jurisdiction,the remaining provisions of this rule shallremain in full force and effect unless other-wise determined by a court of competentjurisdiction.

AUTHORITY: sections 338.140, RSMoSupp. 1989 and 338.280, RSMo 1986.* Thisrule originally filed as 4 CSR 220-2.165.Original rule filed Jan. 3, 1990, effectiveMay 11, 1990. Amended: Filed July 19, 1991,effective Jan. 13, 1992. Moved to 20 CSR

2220-2.165, effective Aug. 28, 2006.

*Original authority: 338.140, RSMo 1939, amended 1981,1989 and 338.280, RSMo 1951, amended 1971, 1981.

20 CSR 2220-2.170 Procedure forImpaired Pharmacist

PURPOSE: This rule establishes an efficientand timely process for the disposition ofinformation and tentative board action con-cerning impaired pharmacists to the attorneygeneral’s office for purposes of preparing acomplaint and streamlines the procedure uti-lized in interviewing pharmacists who arechemically impaired.

(1) The executive director shall receive infor-mation concerning the impairment oflicensees and coordinate any investigationsthat seek to substantiate information concern-ing a possible impairment.

(2) Investigations by board inspectors or divi-sion investigators concerning chemicallyimpaired licensees will be collected andreviewed by the executive director. Cases willbe divided into two (2) categories.

(A) Category A. Chemically impairedlicensees where additional information is evi-dent that known distribution of controlledsubstances or legend drugs to other individu-als has taken place.

(B) Category B. Chemical impairment of alicensee where controlled substances, legenddrugs or alcohol have been acquired for per-sonal use only.

(3) Cases which fall into Category A will bereferred to the board for appropriate action.

(4) Cases which fall within Category B willbe subject to administrative review as a pre-liminary action to facilitate any correctiveactions deemed necessary by the board.

(5) The following shall constitute office pro-cedures involving Category B cases:

(A) Normal procedures for completingfield investigations and assimilating otherpertinent information will be followed;

(B) If the director believes that a case fallsinto Category B of this policy, s/he shall con-sult with the president of the board concern-ing the appropriateness of an administrativereview;

(C) If approval by the president is given,the director shall take actions necessary to setup a meeting with the licensee who is thesubject of the investigation. In addition, otherindividuals such as legal counsel for theboard may be asked to attend, along with anystaff member, as necessary;

(D) A statement concerning due process

procedures and the rights of the licensee willbe read at the beginning of the review meet-ing. A complete record of the administrativereview meeting shall be maintained by theboard office. Notice that the president of theboard has been notified and that s/he hasgiven approval for an administrative fact-find-ing meeting shall be entered into the record;

(E) A format during the fact-finding meet-ing will be followed that allows the licensee toprovide a statement of his/her own as well asa question/answer period allowed to discussthe aspects of the case centering on the chem-ical impairment issues or on any related con-cerns about the individual’s ability to practicepharmacy;

(F) After the fact-finding meeting is con-cluded, a summary will be provided to eachmember of the board within the appropriateagenda, along with recommendations fromthe director as to any action to be taken. Inaddition, the president will be contacted andprovided any follow-up information thatcould warrant changes in administrative pro-cedures. The president, by executive order,may initiate an affidavit to the board attorneyof an intent to file a complaint with theAdministrative Hearing Commission. Oncean order is executed, the information on thecase shall be forwarded to the attorney fornecessary legal preparation; and

(G) The entire board shall consider thecase in closed session as to whether or not tofile a complaint against the licensee and con-sider the recommendations made as to terms.Once the board authorizes a complaint, theattorney for the board shall assure that theappropriate filings take place.

(6) When an impaired pharmacist is disci-plined by the board and a term of the disci-pline is that s/he participate in a chemicaldependence treatment program, the impairedpharmacist shall select a program whichmeets the following guidelines:

(A) Persons who are involved in the treat-ment or counseling of a Missouri board-licensed pharmacist must submit written doc-umentation of their credentials andqualifications to provide treatment or coun-seling;

(B) A written agreement or contract mustbe provided and executed between the coun-selor(s) and the licensee, outlining theresponsibilities of each party for a successfultreatment and monitoring program. Theagreement must include a provision for shar-ing information concerning all aspects oftherapy between the treatment facility orcounselors, or both, and the Missouri Boardof Pharmacy;

(C) An initial evaluation report must becompleted and provided to the board outlin-ing the licensee’s present state of impairment,



the recommended course(s) of treatment, thebeginning date of treatment and an assess-ment of future prospects for recovery;

(D) A copy of the proposed treatment planmust be provided to the board and mustinclude a provision outlining the method ofreferral to an appropriate after-care program;

(E) The counselor(s) must provideprogress reports to the board as follows:

1. Inpatient therapy—monthly reports;2. Outpatient therapy—quarterly re -

ports; and3. After-care programs—semiannual

reports;(F) The treatment program must include

randomized and witnessed body fluid testingand analysis, with any drug presence not sup-ported by a valid prescription to be reportedto the Missouri Board of Pharmacy;

(G) The treatment program must include aprovision for reporting any violation of thetreatment contract or agreement by thelicensee to the board; and

(H) All reports outlined in this protocolmust be provided in writing to the board fora counselor or treatment facility, or both, tobe approved for the treatment of a licenseeundergoing disciplinary board action.

AUTHORITY: sections 338.140, RSMo Supp.1989 and 338.240, RSMo 1986.* This ruleoriginally filed as 4 CSR 220-2.170. Origi-nal rule filed Oct. 1, 1987, effective Jan. 14,1988. Amended: Filed Nov. 15, 1988, effec-tive March 11, 1989. Moved to 20 CSR 2220-2.170, effective Aug. 28, 2006.

*Original authority: 338.140, RSMo 1939, amended 1981,1989 and 338.240, RSMo 1951.

20 CSR 2220-2.175 Well-Being Program

PURPOSE: This rule establishes guidelinesfor the operation of the Well-Being Commit-tee, pursuant to section 338.380, RSMo.

(1) Definitions.(A) Board—State Board of Pharmacy.(B) Committee administrator—The person

who is hired by the contractor or the commit-tee to oversee and manage the Well-BeingProgram.

(C) Contractor—An entity with whom theboard contracts for the purpose of creating,supporting, and maintaining the Well-BeingProgram.

(D) Impairment—An illness, substanceabuse, or physical or mental condition suf-fered by a licensee that is reasonably relatedto the ability to practice pharmacy.

(E) Licensee—Pharmacist, intern pharma-cist, or technician licensed or registered inthe state of Missouri or who has applied forlicensure or registration in the state of Mis-

souri.(F) Well-Being Committee—The commit-

tee established pursuant to section 338.380,RSMo, for the purpose of promoting theearly identification, intervention, treatment,and rehabilitation of pharmacists, internpharmacists, and technicians who may beimpaired by reasons of illness, substanceabuse, or as a result of any physical or mentalcondition.

(G) Well-Being Program—The activitiesand functions of the Well-Being Committee.

(2) The board may contract with a contractorfor purposes of creating, supporting, andmaintaining the Well-Being Program. TheWell-Being Committee may assist the boardin the identification, selection, and evaluationof the contractor, as requested by the board.Operational costs of the Well-Being Programmay be paid by the board, subject to availablefunding. All costs of drug screens and profes-sional and administrative services provided toa licensee shall be paid by the licensee.

(3) Membership and Organization.(A) The Well-Being Committee (here-

inafter committee) shall be composed of thecommittee administrator and three (3)appointed members as follows:

1. One (1) member designated by theMissouri Pharmacy Association;

2. One (1) member designated by theMissouri Society of Health-System Pharma-cists; and

3. One (1) member designated by theState Board of Pharmacy.

(B) The appointed committee membersshall serve staggered three (3)-year terms andmay serve as many terms as their respectiveorganizations deem appropriate. The entitydesignating a member to the committee shalldesignate a person to finish the three (3)-yearterm of any member of the committee whobecomes unable to serve.

(C) The committee shall annually elect achairperson.

(D) The committee shall meet at least two(2) times annually.

(E) The appointed committee membersshall serve without compensation other thanthat allowed by law for service as a boardmember. Each appointed committee membershall be entitled to reimbursement for travelexpenses as deemed appropriate by the board.

(F) The committee administrator shall be anonvoting member of the committee.

(4) An impaired licensee may enter the Well-Being Program voluntarily or by referral ofthe board pursuant to a settlement agreementor other disciplinary order. Licensees enter-ing the Well-Being Program voluntarily shallbe subject to and shall comply with allrequirements of this rule.

(5) Well-Being Committee Duties.(A) The committee shall oversee all

aspects of the general operation of the con-tractor including, but not limited to, oversightof the administration, staffing, financial oper-ations, and case management of the Well-Being Program.

(B) The committee shall assist the board inmonitoring the impaired licensee’s compli-ance with the terms of any disciplinaryorder/agreement.

(C) The committee shall provide the boardaccess to all information and documents per-taining to impaired licensees referred to theWell-Being Program by the board.

(D) The committee shall enter into writtencontracts with each impaired licensee. Thecontract between the committee and theimpaired licensee shall be a minimum of five(5) years in duration, or the time designatedby the board. The contract between thecommittee and impaired licensee shallinclude, but shall not be limited to, the fol-lowing conditions/requirements:

1. Each impaired licensee shall complywith all terms, conditions, or treatment iden-tified, required, or recommended by the con-tractor or the board for the treatment, evalu-ation, monitoring, or assessment of theimpaired licensee;

2. Each impaired licensee shall abstainfrom the possession or consumption of leg-end medication, except as prescribed by atreating prescriber;

3. Each impaired licensee shall abstainfrom illegal possession of alcohol, the con-sumption of alcohol, and the possession orconsumption of illegal drugs;

4. Each impaired licensee shall submitto random drug testing unless otherwise spec-ified by the board, committee, or contractor;

5. Each impaired licensee shall report tothe committee or the contractor all relapsesor other breaches of the contractual terms;

6. Each impaired licensee shall report toor meet with the board, committee, contrac-tor, or the contractor’s appointed designee asmay be requested by the board, committee, orcontractor;

7. Each impaired licensee shall attendsupport meetings as requested by the commit-tee, contractor, or treatment providers;

8. Each impaired licensee referred to theWell-Being Program by the board shall autho-rize the committee to release any and allinformation regarding the impaired licenseeto the board;

9. Each impaired licensee voluntarilyenrolled in the Well-Being Program shallauthorize the committee to release any and allinformation regarding the impaired licenseeto the board upon a violation of any state or


Secretary of State


federal drug law or if the licensee breaches orfails to comply with any terms of a Well-Being contract; and

10. Each impaired licensee shall befinancially responsible for all drug screensand any other professional or administrativeservice rendered on behalf of the impairedlicensee.

(E) The committee shall provide to theboard in writing:

1. An annual action plan and budget tobe approved by the board. The committeeshall report on progress with regard topreparing and implementing the action planand budget as requested by the board or com-mittee;

2. Progress reports with regard to eachlicensee participating in or being assisted bythe Well-Being Program. The identity oflicensees who voluntarily submit to the Well-Being Program shall remain anonymous tothe board for purposes of these reports,except as otherwise provided by this rule.Progress reports shall be provided to theboard at board meetings or upon request ofthe board;

3. Except as otherwise provided by thisrule for voluntary participants, any and allinformation or documentation with regard tothe identification, intervention, treatment,and rehabilitation of any licensee who partic-ipates in, or is assisted by, the Well-BeingProgram;

4. Quarterly income and expensereports. These reports must be itemized andaccount for all income from any and everysource and each expense to any and everyvendor that relates to the Well-Being Programin any way; and

5. Any other report or informationrequested by the board, except as otherwiseprovided by this rule for voluntary partici-pants.

(F) In addition to the other requirements ofthis rule, the committee shall also report, inwriting, to the board:

1. All licensee violations of board disci-plinary orders/agreements, board statutes orregulations, or other state or federal druglaws which occur after the date of the disci-plinary order/agreement or the date thelicensee entered the Well-Being Program,whichever occurs first;

2. Any licensee who fails to enter treat-ment within forty-eight (48) hours followingthe provider’s determination that the licenseeneeds treatment;

3. Any licensee who does not complywith the terms of a Well-Being Program con-tract or who resumes the practice of pharma-cy before the treatment provider has made aclear determination that the licensee is capa-

ble of practicing; and4. Any breach of contract by the Well-

Being Committee or the committee adminis-trator.

(G) The identity of licensees who voluntar-ily submit to the Well-Being Program shallremain anonymous to the board, providedthat upon receipt of a Notice of Non-Compli-ance from the contractor, the committee shallpromptly file a complaint with the boardagainst the licensee identified in the notice.The complaint required by this subsectionshall include the impaired licensee’s name,license number, and the factual basis for thealleged contractual breach/non-compliance.Upon the filing of a complaint, the committeeshall require the committee administrator tosupply to the board any information or docu-mentation with regard to the licensee’s iden-tification, intervention, treatment, compli-ance, and rehabilitation, as requested by theboard or their designated representative.

(H) The committee shall require the costsof drug screens and professional and admin-istrative services to be paid by the impairedlicensee.

(6) Committee Administrator Duties.(A) The committee administrator shall

oversee and manage the daily operations ofthe committee and assist with the administra-tive duties of the committee.

(B) The committee administrator shall pos-sess a combination of education and experi-ence in the area of addiction counseling andbe currently licensed in Missouri as a psy-chologist, psychiatrist, professional coun-selor, or clinical social worker. Upon requestof the committee, the board may waive thelicensure requirements of this subsection forqualified applicants that otherwise possess anequivalent combination of education andexperience, as required by this rule.

(C) The committee administrator shall alsobe familiar with licensees suffering fromimpairment issues which include, but shallnot be limited to, the following:

1. Dependency;2. Alcohol addiction;3. Drug addiction;4. Other addictive diseases;5. Physical issues; and6. Mental health issues.

(D) Upon referral, the duties of the com-mittee administrator shall also include, butare not limited to, assisting the committeewith the following:

1. Organizing and carrying out interven-tions;

2. Referring licensees for appropriateassessment or evaluation and seeing thattreatment recommendations based on the

assessment are followed;3. Monitoring treatment progress and

re-entry contractual compliance; 4. Managing/monitoring random drug

screens;5. Assisting licensees to re-enter prac-

tice from treatment; 6. Assisting with aftercare issues; 7. Any and all reporting to appropriate

agencies, as requested by the board or thecommittee;

8. Program development;9. Outreach education, as requested by

the committee; and10. Other necessary services as deter-

mined by the committee.(E) Upon request by the committee, the

committee administrator shall supply to thecommittee in writing:

1. Any information or documentationregarding the operation of the Well-BeingProgram;

2. All information or documentationwith regard to the identification, interven-tion, treatment, and rehabilitation of anylicensee that is participating in or beingassisted by the Well-Being Program or whohas participated in or been assisted by theWell-Being Program;

3. Progress reports to the committeewith regard to each licensee participating inthe Well-Being Program; and

4. Any reports provided to the board.(F) Upon request, the committee adminis-

trator shall supply to the board in writing:1. Any information requested by the

board regarding the Well-Being Program orany licensee participating in or being assistedby the Well-Being Program, except as other-wise provided herein for voluntary partici-pants; and

2. Any information or documentationwith regard to the identification, interven-tion, treatment, rehabilitation, and compli-ance of any voluntary participant who breach-es or fails to comply with the terms of anyWell-Being Program contract or violates anystate or federal law.

(7) Contractor Duties.(A) Upon referral, the contractor shall be

responsible for requiring evaluators to pro-vide written reports which address whether aparticipant of the Well-Being Program suffersfrom an impairment, identifies the impair-ment, provides recommendations for treat-ment of the impairment, and whether the par-ticipant’s practice of pharmacy should berestricted due to the impairment; and

(B) The contractor shall provide serviceswhen appropriate to impaired licensees whichinclude, but are not limited to, the following:



1. Monitoring compliance of the con-tract between the committee and the impairedlicensee;

2. Assisting the impaired licensee inobtaining evaluation and treatment;

3. Ensuring that treatment recommenda-tions based on the assessment of the licenseeare followed;

4. Monitoring treatment progress andre-entry contractual compliance;

5. Managing/monitoring random drugscreens;

6. Assisting licensees to re-enter prac-tice from treatment;

7. Assisting with aftercare issues; 8. Any and all reporting to appropriate

agencies, as requested by the board or thecommittee;

9. Program development;10. Outreach education, as requested by

the committee; 11. Managing, ensuring, and monitoring

random and scheduled drug screens; and12. Other necessary services as deter-

mined by the committee.(C) The contractor shall assist the board in

monitoring the impaired licensee’s compli-ance with the terms of any disciplinaryorder/agreement.

(D) The contractor shall obtain a writtenrelease from all licensees referred to theWell-Being Program that authorizes the con-tractor to release to the board, the committee,or the committee administrator all informa-tion and documents pertaining to a licenseereferred by the board.

(E) Voluntary Participants. 1. Except as otherwise provided in this

subsection, the identity of licensees who vol-untarily submit to the Well-Being Programshall remain anonymous to the board.

2. The contractor shall file with thecommittee a Notice of Non-Complianceagainst any voluntary participant who breach-es or fails to comply with the terms of anyWell-Being Program contract or who violatesany state or federal drug law. If a complaintis filed by the committee against the licensee,the contractor shall require the committeeadministrator to supply to the board anyinformation or documentation with regard tothe licensee’s identification, intervention,treatment, compliance, and rehabilitation, asrequested by the board.

3. The contractor shall obtain a writtenrelease from all licensees who voluntarilyenter the Well-Being Program that authorizesthe contractor to release any and all informa-tion or documents pertaining to the licenseeto the board or the committee in the event thelicensee breaches or fails to comply with theterms of any Well-Being Program contract or

violates any state or federal drug law.(F) General Reporting.

1. The contractor shall provide to thecommittee in writing:

A. An annual action plan and budgetto be approved by the board. The contractorshall report on progress with regard topreparing and implementing the action planand budget as requested by the board or com-mittee;

B. Quarterly income and expensereports for the Well-Being Program and anyother financial report requested by the boardor the committee;

C. Progress reports with regard toeach licensee participating in or being assist-ed by the Well-Being Program;

D. Any reports provided to the board;E. Any and all information or docu-

mentation with regard to the identification,intervention, treatment, and rehabilitation ofany licensee who participates in, or is assist-ed by, the Well-Being Program;

F. Any other report or informationrequested by the committee; and

G. The information and documenta-tion required by this subsection shall only bereleased to the board pursuant to Chapter338, RSMo, and the rules promulgated there-to.

2. The contractor shall provide to theboard in writing:

A. An annual action plan and budgetas directed by the board. The contractor shallreport on progress with regard to preparingand implementing the action plan and budgetas requested by the board or committee;

B. Progress reports with regard toeach licensee participating in or being assist-ed by the Well-Being Program, provided theidentity of licensees who voluntarily submitto the Well-Being Program shall remainanonymous to the board for purposes of thesereports, except as otherwise provided by thisrule; and

C. Any other report or informationrequested by the board, except as otherwiseprovided by this rule for voluntary partici-pants.

(G) Violation Reporting. In addition to theother requirements of this rule, the contractorshall report, in writing, to the committee:

1. All licensee violations of a board dis-ciplinary order/agreement, any provision ofChapter 338, RSMo, or the board regula-tions, or any state or federal drug law, whichoccurs after the date of the disciplinaryorder/agreement or the date the licenseeentered the Well-Being Program, whicheveroccurs first;

2. Any licensee who fails to enter treat-ment within forty-eight (48) hours following

the provider’s determination that the licenseeneeds treatment; and

3. Any licensee who does not complywith the terms of a Well-Being Program con-tract or who resumes the practice of pharma-cy before the treatment provider has made aclear determination that the licensee is capa-ble of practicing.

(H) The contractor shall require the costsof drug screens and professional and admin-istrative services to be paid by the impairedlicensee.

(8) Confidentiality.(A) The committee and contractor shall

provide the board access to all informationpertaining to each impaired licensee referredto the committee by the board.

(B) In regards to participants referred bythe board and the voluntary participants whohave violated or breached their Well-BeingProgram contracts, the board and committeemay exchange privileged and confidentialinformation, interviews, reports, statements,memoranda, and other documents includinginformation on investigations, findings, con-clusions, interventions, treatment, rehabilita-tion, and other proceedings of the board andcommittee, and other information closed tothe public to promote the identification,interventions, treatment, rehabilitation, anddiscipline (accountability) of licensees whomay be impaired.

(C) All privileged and confidential infor-mation and other information not consideredto be public records or information pursuantto Chapter 610, RSMo, shall remain privi-leged and confidential and closed to the pub-lic after such information is exchanged.

AUTHORITY: section 338.140.1, RSMo 2000and section 338.380, RSMo Supp. 2009.*Original rule filed Aug. 18, 2009, effectiveMarch 30, 2010.

*Original authority: 338.140.1, RSMo 1939, amended1981, 1989, 1997 and 338.380, RSMo 2007.

20 CSR 2220-2.180 Public Records

PURPOSE: This rule establishes standardsfor compliance with Chapter 610, RSMo as itrelates to public records of the State Board ofPharmacy.

(1) All public records of the State Board ofPharmacy shall be open for inspection andcopying by any member of the general publicduring normal business hours, holidaysexcepted, except for those records closed pur-suant to section 610.021, RSMo. All publicmeetings of the Board of Pharmacy not closedpursuant to the provisions of section 610.021,


Secretary of State


RSMo will be open to any member of thepublic.

(2) The Board of Pharmacy establishes theexecutive director of the board as the custodi-an of its records as required by section610.023, RSMo. The executive director isresponsible for the maintenance of theboard’s records and is responsible forresponding to requests for access to publicrecords.

(3) When a request for inspection of publicrecords is made and the individual inspectingthe records requests copies of the records, theboard will collect the appropriate fee forcosts for inspecting and copying of therecords, as outlined in the board’s fee rule, 4CSR 220-4.020. The board may require pay-ment of the fees prior to making available anypublic records.

(4) When a request for access to publicrecords is made and the custodian believesthat access is not required under the provi-sions of Chapter 610, RSMo, the custodianshall inform the individual or entity makingthe request that compliance with the requestcannot be made, specifying in particular whatsections of Chapter 610, RSMo require thatthe record remain closed. Any such corre-spondence or documentation of the denialmade for access to records shall be copied tothe Board of Pharmacy general counsel.Whenever the custodian denies access to therecords, the custodian also shall inform theindividual requesting the records that s/hemay appeal directly to the Board of Pharmacyfor access to the records requested. Theappeal and all information pertaining to theappeal shall be placed on the meeting agendaof the Board of Pharmacy for its next regular-ly scheduled meeting. In the event that theboard decides to reverse the decision of thecustodian, the board shall direct the custodianto so advise the person requesting access tothe information and supply the access to theinformation during regular business hours atthe convenience of the requesting party.

(5) The custodian shall maintain a file whichwill contain copies of all written requests foraccess to records and responses to therequests. These requests shall be maintainedon file with the board for a period of one (1)year and will be maintained as a publicrecord of the board open for inspection byany member of the general public during reg-ular business hours.

(6) Pursuant to section 620.111, RSMo anycomplaints, investigation reports and accom-panying documents or exhibits that are con-sidered closed documents under Chapter 610or 620, RSMo, and are possessed by the

board or any of its agents shall not be dis-closed to any member of the public or to alicensee until the investigation is completed.

(A) Federal or state agency documentsshall not be released without the written con-sent of the federal or state agency involved.

AUTHORITY: sections 338.140, 338.280,Chapters 610 and 620, RSMo 1994.* Thisrule originally filed as 4 CSR 220-2.180.Original rule filed Jan. 19, 1988, effectiveApril 28, 1988. Amended: Filed June 26,1995, effective Feb. 25, 1996. Moved to 20CSR 2220-2.180, effective Aug. 28, 2006.

*Original authority: 338.140, RSMo 1939, amended 1981,1989 and 338.280, RSMo 1951, amended 1971, 1981. ForChapters 610 and 620, please consult the Missouri RevisedStatutes.

20 CSR 2220-2.190 Patient Counseling

PURPOSE: This rule establishes minimumstandards for patient counseling to complywith the federal Omnibus Budget Reconcilia-tion Act of 1990 which requires that all statesestablish standards by January 1, 1993.

(1) Upon receipt of a prescription drug orderand following a review of the available patientinformation, a pharmacist or his/her designeeshall personally offer to discuss matterswhich will enhance or optimize drug therapywith each patient or caregiver of each patient.Counseling shall be conducted by the phar-macist or a pharmacy extern under the phar-macist’s immediate supervision to allow thepatient to safely and appropriately utilize themedication so that maximum therapeutic out-comes can be obtained. If the patient or care-giver is not available, then a written offer tocounsel with a telephone number of the dis-pensing pharmacy at no cost to the patientmust be supplied with the medication so thatthe patient or caregiver may contact the phar-macist for counseling when necessary. In sit-uations where automated pick-up systems areused for providing refill prescriptions topatients, the offer to counsel may be providedwithin the information provided by the kioskto the patient during the processing phaseprior to release of the medication to thepatient. The elements of counseling shallinclude matters which the pharmacist deemssignificant in the exercise of his/her profes-sional judgment and is consistent with applic-able state laws.

(2) Pharmacies shall maintain appropriatepatient information to facilitate counseling.This may include, but shall not be limited to,the patient’s name, address, telephone num-ber, age, gender, clinical information, diseasestates, allergies and a listing of other drugs

prescribed.

(3) Alternative forms of patient informationshall be used to supplement patient counsel-ing when appropriate. Examples may include,but shall not be limited to, written informa-tion leaflets, pictogram labels, video pro-grams, and the like.

(4) Patient counseling, as described in thisrule, shall not be required for inpatients of ahospital, institution or other setting whereother licensed or certified health care profes-sionals are authorized to administer medica-tions.

(5) A pharmacist shall not be required tocounsel a patient or caregiver when thepatient or caregiver refuses consultation.

AUTHORITY: sections 338.140 and 338.280,RSMo 2000.* This rule originally filed as 4CSR 220-2.190. Original rule filed May 1,1992, effective Feb. 26, 1993. Amended:Filed March 4, 1993, effective Oct. 10, 1993.Moved to 20 CSR 2220-2.190, effective Aug.28, 2006. Amended: Filed Aug. 21, 2006,effective April 30, 2007.


20 CSR 2220-2.200 Sterile Compounding

PURPOSE: This rule establishes standardsfor the handling, labeling, distribution, anddispensing of compounded sterile prepara-tions by licensed pharmacies, pursuant to aphysician’s order or prescription.

PUBLISHER’S NOTE: The secretary of statehas determined that the publication of theentire text of the material which is incorporat-ed by reference as a portion of this rule wouldbe unduly cumbersome or expensive. Thismaterial as incorporated by reference in thisrule shall be maintained by the agency at itsheadquarters and shall be made available tothe public for inspection and copying at nomore than the actual cost of reproduction.This note applies only to the reference mater-ial. The entire text of the rule is printed here.

(1) Definitions.(A) Aseptic processing: The technique

involving procedures designed to precludecontamination of drugs, packaging, equip-ment, or supplies by microorganisms duringprocessing.

(B) Batch: Compounding of multiple ster-ile preparation units in a single discreteprocess, by the same individuals, carried out



during one (1) limited time period.(C) Beyond-Use date: A date after which a

compounded preparation should not be usedand is determined from the date the prepara-tion is compounded. Because compoundedpreparations are intended for administrationimmediately or following short-term storage,their beyond-use dates must be assignedbased on criteria different from those appliedto assigning expiration dates to manufactureddrug products.

(D) Biological safety cabinet: Containmentunit suitable for the preparation of low tomoderate risk agents where there is a needfor protection of the preparation, personnel,and environment, according to National San-itation Foundation (NSF) International stan-dards.

(E) Buffer area: An ISO Class 7 or betterarea where the primary engineering control isphysically located that is constructed andused in a manner to minimize the introduc-tion, generation, and retention of particlesinside the room and in which other relevantvariables (e.g., temperature, humidity, andpressure) are controlled as necessary.

(F) Compounding: For the purposes of thisregulation, compounding is defined as in 20CSR 2220-2.400(1). Compounded sterilemedications may include, but are not limitedto:

1. Compounded biologics, diagnostics,drugs, nutrients, and radiopharmaceuticalsthat must or are required to be sterile whenthey are administered to patients, including,but not limited to, the following dosage forms:bronchial and inhaled nasal preparationsintended for deposition in the lung(s), bathsand soaks for live organs and tissues, epiduraland intrathecal solutions, bladder/wound solu-tions, injectables, implantable devices anddosage forms, inhalation solutions, intra-venous solutions, irrigation solutions, oph-thalmic preparations, parenteral nutrition solu-tions, and repackaged sterile preparations.Nasal sprays and irrigations intended fordeposit in the nasal passages may be preparedas nonsterile compounds;

2. An FDA approved manufactured ster-ile product that is either prepared accordingto the manufacturers’ approved labeling/rec-ommendations or prepared differently thanpublished in such labeling; and

3. Assembling point-of-care assembledsystems.

(G) Compounding aseptic containment iso-lator (CACI): A restricted access barrier sys-tem (RABS) that is designed for compound-ing sterile hazardous drugs and designed toprovide worker protection from exposure toundesirable levels of airborne drugs through-out the compounding and material transfer

processes and to provide an aseptic environ-ment for Compounded Sterile Preparation(CSPs).

(H) Compounding aseptic isolator (CAI):A RABS specifically designed for compound-ing sterile non-hazardous pharmaceuticalingredients or CSPs and designed to maintainan aseptic compounding environment withinthe isolator throughout the compounding andmaterial transfer processes.

(I) Controlled area: For purposes of theseregulations, a controlled area is a separateroom designated for preparing sterile prepa-rations or an area designated for preparingsterile preparations that is separated fromother activities/operations by a line of demar-cation that clearly separates the area fromother operations.

(J) Critical area: Any area in the controlledarea where preparations or containers areexposed to the environment.

(K) Critical site: Any surface, pathway, oropening (e.g., vial septa, injection ports,beakers, needle hubs) that provides a directpathway between a compounded sterilepreparation or other ingredient used to com-pound a sterile preparation and the air, envi-ronment or moisture, or that poses a risk oftouch contamination.

(L) CSP: Compounded sterile preparation.(M) Cytotoxic drugs: A pharmaceutical

product that has the capability of direct toxicaction on living tissue that can result in severeleukopenia and thrombocytopenia, depressionof the immune system, and the alteration of ahost’s inflammatory response system.

(N) Emergency dispensing: Is a situationwhere a Risk Level 3 preparation is necessaryfor immediate administration of the prepara-tion and no alternative product or preparationis available and the prescriber is informed thatthe preparation is being dispensed prior toappropriate testing. Documentation of the dis-pensing of the preparation, the prescriber’sapproval for dispensing prior to the receipt oftest results and the need for the emergencymust appear within the prescription record. Aseparate authorization from the prescriber isrequired for each emergency dispensing.

(O) High-Efficiency Particulate Air(HEPA) filter: A filter composed of pleats offilter medium separated by rigid sheets ofcorrugated paper or aluminum foil that directthe flow of air forced through the filter in auniform parallel flow. HEPA filters removeninety-nine point ninety-seven percent(99.97%) of all particles three-tenths (0.3)microns or larger. When HEPA filters areused as a component of a horizontal- or ver-tical-laminar-airflow workbench, an environ-ment can be created consistent with standardsfor an ISO Class 5 environment.

(P) In-use time/date: The time/date beforewhich a conventionally manufactured productor a CSP must be used after it has beenopened or needle-punctured.

(Q) ISO Class 5: An area with less thanthree thousand five hundred twenty (3,520)particles (0.5 μm and larger in size) per cubicmeter.

(R) ISO Class 7: An area with less thanthree hundred fifty-two thousand (352,000)particles (0.5 μm and larger in size) per cubicmeter.

(S) Multiple-dose container: A multipleunit container for articles or compoundedsterile preparations that contains more thanone (1) dose of medication and usually con-tains an antimicrobial preservative.

(T) Parenteral: A sterile preparation ofdrugs for injection through one (1) or morelayers of skin.

(U) Point-of-care assembled system: Aclosed system device that creates a physicalbarrier between diluents, fluids, or otherdrug components and is designed to be acti-vated by the end user by allowing the compo-nents to mix prior to administration.

(V) Primary engineering control (PEC): Asystem that provides an ISO 5 environmentfor the exposure of critical sites when com-pounding sterile preparations. PECs include,but may not be limited to, horizontal/verticallaminar airflow hoods, biological safety cab-inets, and a RABS such as compoundingaseptic isolators (CAIs), or compoundingaseptic containment isolators (CACIs).

(W) Process validation or simulation:Microbiological simulation of an asepticprocess with growth medium processed in amanner similar to the processing of thepreparation and with the same container orclosure system.

(X) Quality assurance: For purposes ofthese regulations, quality assurance is the setof activities used to ensure that the processesused in the preparation of sterile drug prepa-rations lead to preparations that meet prede-termined standards of quality.

(Y) Quality control: For the purposes ofthese regulations, quality control is the set oftesting activities used to determine that theingredients, components, and final sterilepreparations prepared meet predeterminedrequirements with respect to identity, purity,nonpyrogenicity, and sterility.

(Z) Restricted access barrier system(RABS): A primary engineering control thatis comprised of a closed system made up offour (4) solid walls, an air-handling system,and transfer and interaction devices. Thewalls are constructed so as to provide surfacesthat are cleanable with coving between walljunctures. The air-handling system provides


Secretary of State


HEPA filtration of inlet air. Transfer of mate-rials is accomplished through air locks, gloverings, or ports. Transfers are designed to min-imize the entry of contamination. Manipula-tions can take place through either glove portsor half suits. Examples of a RABS mayinclude, but is not limited to, a CAI or CACI.

(AA) Repackaging: The subdivision ortransfer of a compounded preparation fromone (1) container or device to a different con-tainer or device.

(BB) Single-dose/single-unit container/vial:A container/vial of medication intended foradministration that is meant for use in a singlepatient for a single case, procedure, or injec-tion.

(CC) Sterilization: A validated process usedto render a preparation free of viable organ-isms.

(DD) Temperatures:1. Frozen means temperatures between

twenty-five degrees below zero and tendegrees below zero Celsius (-25 and -10°C)(thirteen degrees below zero and fourteendegrees Fahrenheit (-13 and 14°F));

2. Refrigerated means temperaturesbetween two and eight degrees Celsius (2 and8°C) (thirty-six and forty-six degrees Fahren-heit (36 and 46°F)); and

3. Controlled room temperature means atemperature maintained thermostatically thatencompasses the usual and customary work-ing environment 20° to 25° Celsius (68° to78° F). Excursions between 15° and 30°Celsius (59° to 86° F) as commonly experi-enced in pharmacies and other facilities shallbe deemed compliant.

(EE) USP: The United States Pharma-copeia and the National Formulary (USP-NF) as adopted and published by the UnitedStates Pharmacopeial Convention, effectiveMay 2013. Copies of the USP-NF are pub-lished by, and available from, USP, 12601Twinbrook Parkway, Rockville, MD 20852-1790 or online at http://www.usp.org/. TheUSP-NF is incorporated herein by reference.This rule does not include any later amend-ments or additions to the USP-NF.

(FF) Validation: Documented evidenceproviding a high degree of assurance that spe-cific processes will consistently produce apreparation meeting predetermined specifica-tions and quality attributes.

(GG) Definitions of sterile compoundedpreparations by risk level:

1. Risk Level 1: Applies to compoundedsterile preparations that exhibit characteris-tics A., B., or C., stated below. All RiskLevel 1 preparations shall be prepared withsterile equipment and sterile ingredients andsolutions in an ISO Class 5 environment.Risk Level 1 includes the following:

A. Preparations:(I) Stored at controlled room tem-

perature and assigned a beyond-use date offorty-eight (48) hours or less; or

(II) Stored under refrigeration andassigned a beyond-use date of seven (7) daysor less; or

(III) Stored frozen and assigned abeyond-use date of thirty (30) days or less;

B. Unpreserved sterile preparationsprepared for administration to one (1) patientor batch-prepared preparations containingsuitable preservatives prepared for adminis-tration to more than one (1) patient with anassigned beyond-use date that does not exceedthe beyond-use date allowed under subpara-graph (1)(GG)1.A. of this rule;

C. Preparations prepared by closed-system aseptic transfer of sterile, nonpyro-genic, finished pharmaceuticals (e.g., fromvials or ampules) obtained from licensedmanufacturers into sterile final containersobtained from licensed manufacturers with anassigned beyond-use date that does not exceedthe beyond-use date allowed under subpara-graph (1)(GG)1.A. of this rule;

2. Risk Level 2: Sterile preparationsexhibit characteristic A., B., or C., statedbelow. All Risk Level 2 preparations shall beprepared with sterile equipment and sterileingredients in an ISO Class 5 environmentand with closed-system transfer methods.Risk Level 2 includes the following:

A. Preparations stored under refriger-ation and assigned a beyond-use date greaterthan seven (7) days, or preparations storedfrozen and assigned a beyond-use date greaterthan thirty (30) days, or preparations stored atcontrolled room temperature and assigned abeyond-use date greater than forty-eight (48)hours;

B. Batch-prepared preparations with-out preservatives that are intended for use bymore than one (1) patient;

C. Preparations compounded by com-plex or numerous manipulations of sterileingredients obtained from licensed manufac-turers in a sterile container or reservoirobtained from a licensed manufacturer byusing closed-system aseptic transfer (e.g.,automated compounder);

3. Risk Level 3: Sterile preparationsexhibit either characteristic A. or B.:

A. Preparations compounded fromnonsterile ingredients or compounded withnonsterile components, containers, or equip-ment before terminal sterilization;

B. Preparations prepared by combin-ing multiple ingredients (sterile or nonsterile)by using an open-system transfer or openreservoir before terminal sterilization.

(2) Policy and Procedure Manual/ReferenceManuals.

(A) A manual, outlining policies and pro-cedures encompassing all aspects of RiskLevel 1, 2, and 3 compounding performed,shall be available for inspection at the phar-macy. The manual shall be reviewed on anannual basis. The pharmacy shall have cur-rent reference materials related to sterilepreparations.

(3) Personnel Education, Training, and Eval-uation.

(A) Risk Level 1: All pharmacy personnelpreparing sterile preparations must receivesuitable didactic and experiential training inaseptic technique and procedures and shall beskilled and trained to accurately and compe-tently perform the duties assigned. Additionaltraining must be provided if the risk level ofsterile activity conducted by the individualchanges or if there is a change in compoundingmethods performed. To ensure competency,individuals preparing sterile preparationsmust successfully pass an Aseptic TechniqueSkill Assessment that complies with section(10) of this rule. The pharmacy shall establishpolicies and procedures for staff training andassessment.

(B) Risk Level 2: In addition to Risk Level1 requirements, personnel training mustinclude assessment of competency in all RiskLevel 2 procedures via process simulation.

(C) Risk Level 3: In addition to Risk Level1 and 2 requirements, operators have specificeducation, training, and experience to pre-pare Risk Level 3 preparations. The pharma-cist knows principles of good compoundingpractice for risk level preparations, includ-ing—

1. Aseptic processing;2. Quality assurance of environmental,

component, and end-preparation testing;3. Sterilization; and4. Selection and use of containers, equip-

ment, and closures.

(4) Storage and Handling in the Pharmacy.(A) Risk Level 1 and 2: Solutions, drugs,

supplies, and compounding equipment mustbe stored and maintained in a manner thatwill maintain the chemical and microbiologi-cal stability of CSPs. Refrigeration, freezerand, if applicable, incubator temperaturesshall be documented daily. Other storageareas shall be inspected regularly to ensurethat temperature and lighting meet require-ments. Drugs and supplies shall be shelvedabove the floor. Removal of drugs and sup-plies from boxes shall be done outside thecontrolled and buffer areas. Removal of usedsupplies from the controlled area shall be




Secretary of State


done at least daily. Preparation recall proce-dures must comply with section (21) of thisrule and must permit retrieving affectedpreparations from specific involved patients.

(B) Risk Level 3: In addition to Risk Level1 and 2 requirements, the pharmacy mustestablish procedures for procurement, identi-fication, storage, handling, testing, and recallof components and finished preparations.Finished Risk Level 3 preparations awaitingtest results must be quarantined under mini-mal risk for contamination in a manner thatwill maintain chemical and microbiologicalstability.

(5) Facilities and Equipment. The pharmacyshall establish and follow proper controls toensure environmental quality, prevent envi-ronmental contamination, and maintain airquality in all ISO classified areas.

(A) Risk Level 1: Risk Level 1 prepara-tions must be prepared in a PEC located in acontrolled area that meets the requirements ofthis rule. A sink with hot and cold water mustbe near, but not in, the controlled area. Thecontrolled area and inside equipment must becleaned and disinfected as provided in section(17) of this rule. Activities within the criticalarea shall be kept to a minimum to maintainthe ISO classified environment. Primaryengineering controls shall meet the require-ments of section (6) of this rule; prefiltersmust be visually inspected on a regularlyscheduled basis and replaced according tomanufacturer’s specifications. Pumps utilizedin the compounding process shall be recali-brated and documented according to manu-facturer procedures.

(B) Risk Level 2: In addition to all RiskLevel 1 requirements, Risk Level 2 prepara-tions must be prepared in a PEC located in abuffer area or prepared in a RABS locatedwithin a controlled area. Applicable environ-mental monitoring of air and surfaces must beconducted. Risk Level 2 preparations shall ata minimum remain a Risk Level 2 for the lifeof the preparation.

(C) Risk Level 3: In addition to Risk Level1 and 2 requirements, Risk Level 3 prepara-tions must be prepared in a PEC located in abuffer area or prepared in a RABS locatedwithin a controlled area. All non-sterileequipment that is to come in contact with thesterilized final preparation must be sterilizedbefore introduction in the buffer area or intothe RABS. Once compounded, Risk Level 3preparations shall at a minimum remain RiskLevel 3 for the life of the preparation.

(D) Automated compounding devices shallbe calibrated according to manufacturer pro-cedures for content, volume, weight, andaccuracy prior to initial use and prior to com-

pounding each day the device is in use ormore frequently as recommended by manu-facturer guidelines. Calibration results shallbe reviewed by a pharmacist to ensure com-pliance. The identity of the reviewing phar-macist and the review date shall be docu-mented in the pharmacy’s records.

(E) All PECs and ISO classified areas shallbe certified to ensure compliance with therequirements of this rule prior to beginningsterile compounding activities and every six(6) months thereafter. Certification shall beconducted by competent staff/vendors usingrecognized and appropriate certification andtesting equipment. Certification results shallbe reviewed by a pharmacist once received.The pharmacist’s identity and date of reviewmust be documented in the pharmacy’srecords. Deficiencies or failures shall beinvestigated and corrected prior to furthercompounding which may include recertifica-tion of the PEC/ISO classified area.

1. The PEC and ISO classified areasmust be recertified when— 1) any changes ormajor service occurs that may affect airflowor environmental conditions or 2) the PEC orroom is relocated or the physical structure ofthe ISO classified area has been altered.

2. Corrections may include, but are notlimited to, changes in the use of the affectedPEC or ISO classified area or initiating arecall.

(F) Pressure differential: If the sterile com-pounding area is equipped with a device tomonitor pressure differential between ISOclassified air spaces, pressure differentialresults must be recorded and documentedeach day that the pharmacy is open for phar-macy activities. Alternatively, a continuousmonitoring system may be used to recordpressure differential results if the systemmaintains ongoing documentation of pressurerecordings or maintains pressure alerts thatare reviewed daily.

(6) Primary Engineering Controls (PECs).(A) PECs must be properly used, operat-

ed, and maintained and must be located outof traffic patterns and away from conditionsthat could adversely affect their operation ordisrupt intended airflow patterns (e.g., venti-lation systems or cross-drafts).

(B) PECs shall maintain ISO Class 5 orbetter conditions during dynamic operatingconditions and while compounding sterilepreparations, including, when transferringingredients into and out of the PEC and dur-ing exposure of critical sites.

(C) PECs shall provide unidirectional(laminar flow) HEPA air at a velocity suffi-cient to prevent airborne particles from con-tacting critical sites.

(D) The recovery time to achieve ISO Class5 air quality in any PEC shall be identified inthe pharmacy’s policies and procedures. Pro-cedures must be developed to ensure adequaterecovery time is allowed before or during com-pounding operations and after material trans-fer.

(7) Controlled Areas. The controlled areashall be designed, maintained, and controlledto allow effective cleaning and disinfectionand to minimize the risk of contamination andthe introduction, generation, and retention ofparticles inside the PEC.

(A) Controlled areas must be clean andwell-lit and shall be free of insects, rodents,and/or other vermin. Trash shall be disposedof in a timely and sanitary manner and atleast daily. Tacky mats or similar articles areprohibited in the controlled area or any ISOclassified environment.

(B) Traffic flow in or around the controlledarea shall be minimized and controlled. Fooditems, chewing gum, eating, drinking, andsmoking are prohibited in the area.

(C) Non-essential objects that shed parti-cles shall not be brought into the controlledarea, including, but not limited to, pencils,cardboard cartons, paper towels, and cottonitems (e.g., gauze pads). Furniture, carts,supplies, and equipment shall be removedfrom shipping cartons/containers and proper-ly cleaned and disinfected with sterile alcoholor an equivalently effective non-residue gen-erating disinfectant before entering any ISOclassified area. No shipping or other externalcartons may be taken into the controlled areaor an ISO classified area.

(D) Only supplies essential for compound-ing shall be stored in the controlled area.Supplies or other non-essential equipmentshall not be stored in or on the PEC.

(8) Garbing and Hand Hygiene. Individualsengaged in, or assisting with, CSPs shall betrained and demonstrate competence in prop-er personal garbing, gloving, and handhygiene. Competence must be documentedand assessed through direct visual observa-tion as part of the aseptic technique skillassessment required by this rule.

(A) Risk Level 1: Low-particulate and non-shedding gowns, hair covers, gloves, facemasks, and, if applicable, beard covers mustbe worn during compounding and cleaning.All head and facial hair must be covered.During sterile preparation, gloves shall bedisinfected before use and frequently there-after with a suitable agent and changed whenintegrity is compromised. All personnel inthe controlled area must be appropriatelygarbed as required by this section.

(B) Risk Level 2 and Risk Level 3: In addi-tion to Risk Level 1 requirements, shoe cov-ers and sterile gloves must be worn whilecompounding and cleaning, including, overRABS gloves. All personnel in the controlledor buffer area must garb as required by thissection.

(9) Aseptic Technique and Preparation. Appro-priate quality control methods shall be main-tained over compounding methods at all timesto ensure proper aseptic technique.

(A) Risk Level 1: Sterile preparations mustbe prepared in an ISO Class 5 environment.Personnel shall scrub their hands and fore-arms a minimum of thirty (30) seconds andremove debris from underneath fingernailsunder warm running water before donning therequired gloves. Eating, drinking, and smok-ing are prohibited in the controlled area.Talking shall be minimized to reduce air-borne particles. Ingredients shall be deter-mined to be stable, compatible, and appropri-ate for the preparation to be prepared,according to manufacturer, USP, or scientificreferences. Ingredients and containers shallbe inspected for defects, expiration, andintegrity before use. Only materials essentialfor aseptic compounding shall be placed inthe PEC. Supplies, equipment, and the sur-faces of ampules and vials shall be disinfect-ed before entering the PEC by wiping theouter surface with sterile alcohol or an equiv-alently effective non-residue generating disin-fectant. Sterile components shall be arrangedin the PEC to allow a clear, uninterruptedpath of HEPA-filtered air over critical sites.Automated devices and equipment shall becleaned, disinfected, and placed in the PECto enable laminar airflow. Aseptic techniqueshall be used to avoid touch contamination ofcritical sites of containers and ingredients.Particles shall be filtered from solutions, ifapplicable. Needle cores shall be avoided.The pharmacist shall check before, during,and after preparation to verify the identityand amount of ingredients before release.

(B) Risk Level 2: In addition to Risk Level1 requirements, a file containing the formula,components, procedures, sample label, andfinal evaluation shall be made for each prepa-ration batch. A separate work sheet and lotnumber for each batch shall be completed.When combining multiple sterile preparations,a second verification of calculations shall takeplace. The pharmacist shall verify dataentered into any automatic compounder beforeprocessing and check the end preparation foraccuracy.

(C) Risk Level 3: In addition to Risk Level1 and 2 requirements, nonsterile componentsmust meet compendial standards or must be

verified by a pharmacist and a certificate ofanalysis. Batch preparation files shall alsoinclude comparisons of actual with anticipat-ed yields, sterilization methods, and quaran-tine specifications. Presterilized containersshall be used when feasible. Final containersmust be sterile and capable of maintainingpreparation integrity throughout the shelflife. Sterilization methods must be based onproperties of the preparation, and must beconducted in a method recognized by USP forthe preparation and confirmed through steril-ity testing using a testing method recognizedby USP for the preparation.

(D) Single-dose vials/containers and phar-macy bulk vial/containers exposed to ISOClass 5 or cleaner air may be used in com-pounding until the assigned in-use time whichshall not exceed six (6) hours after initial nee-dle puncture, unless otherwise specified bythe manufacturer. Opened single-doseampules shall not be stored for any time peri-od. The in-use time must be placed on thevial/container. For multiple-dose vials/con-tainers with no antimicrobial preservativeused in the preparation of radiopharmaceuti-cals whose beyond-use dates are twenty-four(24) hours or less, the in-use time shall notexceed twenty-four (24) hours.

(E) Unless otherwise specified by the man-ufacturer, multiple-dose vials/containers withan antimicrobial preservative may be used incompounding until the assigned in-use datewhich shall not exceed twenty-eight (28) daysafter initially entering or opening the vial/con-tainer (e.g., needle-puncture). The in-use datemust be placed on the vial/container.

(10) Aseptic Technique Skill Assessment.Individuals engaged in sterile compoundingmust take and successfully pass an aseptictechnique skill assessment to verify asepticcompetency. The assessment must include adirect visual observation of the individual’saseptic competency during a process simula-tion that represents the most challenging orstressful conditions encountered or per-formed by the person being evaluated. Theassessment must include media-fill testing forall risk levels performed. Self-observation isnot allowed.

(A) The required visual observation shallassess:

1. Proper aseptic technique, manipula-tions, and work practices, including, but notlimited to, avoiding touch contamination,proper use of first air, and if applicable, ster-ilizing high risk CSPs;

2. Cleaning and disinfection; 3. Hand hygiene, gloving, and garbing;4. Identifying, weighing, and measuring

of ingredients;

5. Maintaining sterility in ISO Class 5areas;

6. Labeling and inspecting CSPs forquality.

(B) Media-Fill Testing. Pharmacies shallestablish and follow policies and proceduresfor media-fill testing. Media-fill testing shallcomply with USP Chapter 797’s recommend-ed procedures and methods and must be con-ducted using the most challenging or stressfulconditions/compounding actually encoun-tered or performed by the person being eval-uated using the same container or closure. Aminimum of three (3) media-fill tests must becompleted during initial media-fill testing andone (1) media-fill test completed for ongoingtesting.

(C) Frequency: The required Aseptic Tech-nique Skill Assessment must be conductedprior to initial compounding and every twelve(12) months thereafter for Risk Levels 1 and 2compounding and every (6) months thereafterfor Risk Level 3 compounding. Additionally,an Aseptic Technique Skill Assessment mustbe conducted whenever unacceptable tech-niques are observed or discovered, if the risklevel of sterile activity conducted by the indi-vidual changes, or if there is a change incompounding methods performed.

(D) Individuals who fail written tests; visu-al observation of hand hygiene, garbing, oraseptic technique; or media-fill tests mustundergo immediate requalification throughadditional training by competent compound-ing personnel. Individuals who fail visualobservation of hand hygiene, garbing, oraseptic technique; or media-fill tests mustpass a reevaluation in the deficient areabefore they can resume compounding of ster-ile preparations. Individuals who fail media-fill testing must pass three (3) successivemedia-fill tests prior to resuming sterile com-pounding.

(11) Record Keeping.(A) Risk Level 1 and 2: The following

must be documented/maintained: 1. Training and competency evaluation

of pharmacy personnel involved in sterilecompounding, including, the dates andresults of the required aseptic technique train-ing, aseptic technique skill assessment, andmedia-fill testing;

2. Refrigerator, freezer and, if applica-ble, incubator temperature logs;

3. Certification dates and results for anyPEC or ISO classified area;

4. Manufacturer manuals that are reliedupon to maintain compliance with this rule;

5. Other facility quality control logs, asappropriate, including all maintenance,cleaning, and calibration records;



6. If applicable, pressure recordingsincluding documentation of the review of con-tinuous monitoring system results as requiredby subsection (5)(F);

7. Any end-preparation testing records;and

8. Single preparation and batch prepara-tion records.

(B) Risk Level 3: In addition to Risk Level1 and 2 requirements, record requirementsfor Risk Level 3 preparations must include:

1. Preparation work sheet;2. Sterilization records; 3. Quarantine records, if applicable; 4. End-preparation evaluation and test-

ing records as required in section (14); and 5. Ingredient validation records as

required in section (14).(C) All records and reports shall be main-

tained either electronically or physically fortwo (2) years and shall be readily retrievableand subject to inspection by the board of phar-macy or its agents. At a minimum, recordsshall be physically or electronically producedimmediately or within two (2) hours of arequest from the board or the board’s autho-rized designee.

(12) Labeling.(A) Sterile preparations shall be labeled in

accordance with section 338.059, RSMo andwith the following supplemental information:

1. Beyond-use date;2. Storage requirements if stored at

other than controlled room temperature;3. Any device specific instructions; 4. Auxiliary labels, when applicable;

and5. If applicable, a designation indicating

the preparation is hazardous.

(13) Beyond-Use Dating.(A) Risk Level 1 and Risk Level 2: All

sterile preparations must bear a beyond-usedate. Beyond-use dates must be assignedbased on current drug and microbiologicalstability information and sterility considera-tions.

(B) Risk Level 3: In addition to all RiskLevel 1 requirements, there must be a reliablemethod for establishing all beyond-use dates,including laboratory testing of preparationstability, pyrogenicity, particulate contamina-tion, and potency. Beyond-use dating notspecifically referenced in the productsapproved labeling or not established bypreparation specific instrumental analysisshall be limited to thirty (30) days. Theremust be a reliable method for establishing allbeyond-use dating. Preparations assigned abeyond-use date of greater than thirty (30)days shall have laboratory validation of prepa-

ration stability and potency.

(14) End-preparation Evaluation.(A) Risk Level 1: The final preparation

must be inspected for clarity, container leaks,integrity, and appropriate solution cloudinessor phase separation, solution color, and solu-tion volume. The pharmacist must verify thatthe preparation was compounded accuratelyas to the ingredients, quantities, containers,and reservoirs. Background light or othermeans for the visual inspection of prepara-tions for any particulate and/or foreign mattermust be used as part of the inspectionprocess, provided an alternate means ofinspection shall be used if a visual inspectionor exposure to the preparation may pose ahealth hazard.

(B) Risk Level 2: All Risk Level 1 require-ments must be met.

(C) Risk Level 3: In addition to all RiskLevel 1 requirements, the process validationprocedure shall be supplemented with a pro-gram of end-preparation sterility testingaccording to a formal sampling plan. Samplesshall be statistically valid to ensure that batch-es are sterile. A method for recalling batchpreparations shall be established if preparationtesting results are unacceptable. A samplefrom each sterile preparation/batch must betested for sterility. A sample from each par-enteral sterile preparation/batch must also betested for pyrogenicity. Risk Level 3 prepara-tions must be quarantined and stored to main-tain chemical and microbiological stabilitypending results of end-preparation testing.

1. Sterility testing: Sampling for thesterility test shall occur promptly upon thecompletion of preparation. The sterility test,including the sampling scheme, shall be con-ducted according to a method recognized forthe preparation by USP Chapter 71.

2. Pyrogen/Endotoxin testing: Sterileparenteral preparations prepared from non-sterile drug components shall be tested forpyrogen or endotoxin according to a methodrecognized by USP Chapter 151 for pyrogentesting and recognized by USP Chapter 85 forendotoxin testing.

3. Potency: The pharmacy shall have aprocedure for a pre-release check of thepotency of the active ingredients in the com-pounded sterile preparation prepared fromnon-sterile bulk active ingredients. The pro-cedure shall include at least the following ver-ifications by a pharmacist:

A. The lot of the active ingredientsused for compounding have the necessarylabeling, potency, purity, certificate of analy-sis, and other relevant qualities;

B. All weighings, volumetric mea-surements, and additions of ingredients were

carried out properly;C. The compounding or control

records include documentation that the fillvolumes of all units available for release werechecked and were correct; and

D. The final potency is confirmed byinstrumental analysis for sterile preparationsthat have been assigned a beyond-use date ofmore than thirty (30) days.

(D) Emergency Dispensing of a Risk Level3 Sterile Preparation: When a compoundedRisk Level 3 preparation must be releasedprior to the completion of testing, the sterilepreparation may be dispensed pending testresults. Emergency dispensing shall bedefined as, and comply with, subsection(1)(N) of this rule.

(15) Storage, Handling, and Transport. Ster-ile preparations shall be packaged, stored, dis-pensed, and distributed in a manner that willmaintain the preparation’s chemical andmicrobiological stability until the assignedbeyond-use date or until delivery to the patientor intended recipient. The pharmacist-in-charge shall assure the environmental controlof all sterile compounded preparationsshipped. Sterile preparations shall be trans-ported so as to be protected from excesses oftemperatures and light within appropriatepackaging or delivery containers that maintainnecessary storage conditions to preserve thequality and integrity of sterile preparations.The pharmacy shall follow written proceduresthat specify packing techniques, configura-tion, and materials for groups of preparationswith common storage characteristics and forspecific preparations where unique storageconditions are required to retain adequate sta-bility and preparation quality.

(16) Point-of-Care Assembled Systems.Assembly of point-of-care assembled systemsshall be considered Risk Level 1 compound-ing. Point-of-care assembled systems shall beassigned a beyond-use date which may exceedthe beyond-use date authorized for Risk Level1 preparations provided the date is assigned inaccordance with the manufacturer’s recom-mendations or labeling.

(A) When dispensed, an assembled non-activated system shall be labeled withbeyond-use dates for both activated and non-activated states. The compounding recordmust document both dates. The beyond-usedate of an assembled non-activated systemshall be limited to a maximum of fifteen (15)days unless the pharmacy has documentationfrom the system’s manufacturer that a longerdate is acceptable.

(B) Point-of-care assembled systems shallbe assembled and stored in accordance with


Secretary of State




the manufacturer’s labeling and recommen-dations.

(17) General Cleaning and DisinfectionRequirements. Except as otherwise providedherein, cleaning and disinfection of con-trolled and buffer areas, supplies, and equip-ment shall be performed and conducted inaccordance with USP Chapter 797 time-frames and procedures. Controlled areas thatdo not meet ISO air classifications shall becleaned and disinfected as required by USPChapter 797 for segregated compoundingareas. If compounding is done less frequentlythan the cleaning and disinfection timeframesspecified in USP Chapter 797, cleaning anddisinfection must occur before each com-pounding session begins.

(A) The pharmacy shall establish and followwritten policies and procedures governing allaspects of cleaning and disinfection, includingapproved cleaning/disinfecting agents andmaterials, schedules of use, and methods ofapplication.

(B) Individuals shall be trained in propercleaning and disinfection procedures prior toperforming such activities. Training shallinclude direct visual observation of the indi-vidual’s cleaning and disinfecting process byqualified staff. The individual shall be annu-ally reassessed for competency through directvisual observation. Documentation of therequired training and training dates shall bemaintained in the pharmacy’s records. Indi-viduals who fail to demonstrate competencyshall be reinstructed and successfully reeval-uated prior to any further cleaning or disin-fection.

(C) Cleaning and disinfection activities shallbe performed using approved cleaning/disin-fection agents and procedures described in thepharmacy’s written policies and procedures.Manufacturers’ directions for minimum con-tact time shall be followed.

(D) All cleaning tools (e.g., wipes,sponges, and mop heads) must be low-lintand dedicated for use in the controlled areaand ISO classified areas.

(E) Primary engineering controls shall becleaned with a germicidal cleaning agent fol-lowed by sterile alcohol. Sterile water forirrigation shall be used to dilute all agentsused inside the PEC that require dilution.

(F) At a minimum, the critical area shallbe cleaned and disinfected prior to com-pounding, between batches, and whenevercontamination is suspected using sterile alco-hol which is allowed to dry immediately priorto compounding.

(18) Environmental Sampling/Testing. Thepharmacy shall establish and follow proper

controls to ensure environmental quality, pre-vent environmental contamination, and main-tain air quality in all ISO classified areas.Applicable environmental monitoring of airand surfaces must be conducted. Air moni-toring must be conducted prior to initial com-pounding and every six (6) months thereafter.Surface sampling/monitoring must be con-ducted every six (6) months for Risk Level 2and every thirty (30) days for Risk Level 3compounding.

(19) Cytotoxic Drugs.(A) The following additional requirements

are necessary for those licensed pharmaciesthat prepare cytotoxic drugs to insure the pro-tection of the personnel involved:

1. Cytotoxic drugs shall be compoundedin a vertical flow, Class II biological safetycabinet or a CACI. If used for other prepara-tions, the cabinet must be thoroughlycleaned;

2. Protective apparel shall be worn bypersonnel compounding cytotoxic drugswhich shall include disposable masks, gloves,and gowns with tight cuffs;

3. Appropriate safety and containmenttechniques for compounding cytotoxic drugsshall be used in conjunction with the aseptictechniques required for preparing sterilepreparations. Chemotherapy preparationsshould be compounded using a closed systemtransfer device;

4. Appropriate disposal containers forused needles, syringes, and if applicable,cytotoxic waste from the preparation ofchemotherapy agents and infectious wastefrom patients’ homes. Disposal of cytotoxicwaste shall comply with all applicable local,state, and federal requirements;

5. Written procedures for handlingmajor and minor spills and generated wasteof cytotoxic agents must be developed andmust be included in the policy and proceduremanual; and

6. Prepared doses of cytotoxic drugsmust be labeled with proper precautionsinside and outside, and shipped in a mannerto minimize the risk of accidental rupture ofthe primary container.

(20) Remedial Investigations. A remedialinvestigation shall be required if any environ-mental monitoring sample demonstrates acolony forming unit (CFU) count thatexceeds USP Chapter 797 recommendedaction levels for the type of sampling. Aremedial investigation shall include resam-pling of all affected areas to ensure a suitablestate of microbial control. CSPs and anyingredients used within the compoundingprocess that are part of the remedial investi-

gation shall be quarantined until the results ofthe investigation are known. The pharmacyshall ensure that no misbranded, contaminat-ed, or adulterated CSP is administered or dis-pensed for patient use.

(A) If an environmental monitoring sampletaken from an ISO-5 classified area exceedsUSP 797 action levels, the pharmacy mustcease compounding in the affected ISO clas-sified area until resampling shows a suitablestate of microbial control has been achievedin the affected area. However, a pharmacymay continue to compound during the reme-dial investigation if—

1. The affected ISO classified area iscleaned and disinfected by using a germicidalcleaning agent and a sporicidal agent fol-lowed by sterile alcohol;

2. The beyond-use date assigned to allpreparations is no greater than twelve (12)hours; and

3. The affected ISO classified area isresampled under dynamic conditions. If theresampling exceeds USP Chapter 797 actionlevels, compounding must cease until resam-pling shows a suitable state of microbial con-trol has been achieved in the affected area,unless otherwise authorized by the board orboard’s authorized designee to continue com-pounding upon a showing the facility can beoperated in a manner not to endanger thepublic safety.

(B) If an environmental monitoring sampletaken from an ISO-7 classified buffer areaexceeds USP 797 action levels, the pharmacymust cease compounding in the affected ISOclassified buffer area until resampling showsa suitable state of microbial control has beenachieved in the affected area. However, apharmacy may continue to compound duringthe remedial investigation if—

1. The affected ISO classified area iscleaned and disinfected by using a germicidalcleaning agent and a sporicidal agent;

2. The beyond-use date assigned to RiskLevel 1 preparations is not greater than twen-ty-four (24) hours or, for Risk level 2 and 3preparations, no greater than twelve (12)hours; and

3. The affected ISO classified area isresampled under dynamic conditions. If two(2) consecutive resamplings exceed USP 797action levels, compounding must cease untilresampling shows a suitable state of microbialcontrol has been achieved in the affectedarea, unless otherwise authorized by theboard or board’s authorized designee to con-tinue compounding upon a showing the facil-ity can be operated in a manner not to endan-ger the public health or safety.


Secretary of State


(C) The pharmacy shall notify the board inwriting within three (3) days of any environ-mental monitoring sample collected as part ofa remedial investigation that exceeds USP797 action levels.

(21) Recalls. A recall must be initiated when adispensed CSP is deemed to be misbranded,adulterated, or non-sterile or if end-prepara-tion testing results are out of specification.The pharmacy shall notify the prescriber ofthe nature of the recall, the problem(s) iden-tified, and any recommended actions toensure public health and safety. In caseswhere the CSP has the potential to harm thepatient, the same notification shall be provid-ed to all patients that received the recalledCSP(s). Any recall initiated by a pharmacyshall be reported, in writing, to the boardwithin three (3) business days. The pharmacyshall document their activities related to therecall.

AUTHORITY: sections 338.140, 338.240,and 338.280, RSMo 2016, and section338.010, RSMo Supp. 2018.* This rule origi-nally filed as 4 CSR 220-2.200. Original rulefiled May 4, 1992, effective Feb. 26, 1993.Amended: Filed Oct. 28, 1994, effective May28, 1995. Rescinded and readopted: FiledDec. 3, 2002, effective July 30, 2003. Movedto 20 CSR 2220-2.200, effective Aug. 28,2006. Amended: Filed Feb. 6, 2008, effectiveAug. 30, 2008. Emergency amendment filedJuly 25, 2016, effective Aug. 4, 2016, expiredFeb. 23, 2017. Amended: Filed July 25, 2016,effective Jan. 30, 2017. Emergency amend-ment filed Aug. 20, 2018, effective Aug. 30,2018, expired Feb. 28, 2019. Amended: FiledAug. 20, 2018, effective Feb. 28, 2019.

*Original authority: 338.010, RSMo 1939, amended 1951,1989, 1990, 2007, 2009, 2011, 2014, 2017, 2018; 338.140,RSMo 1939, amended 1981, 1989, 1997, 2011; 338.240,RSMo 1951, amended 2011; and 338.280, RSMo 1951,amended 1971, 1981.

20 CSR 2220-2.300 Record Confidentialityand Disclosure

PURPOSE: This rule establishes require-ments for the confidentiality and disclosure ofrecords related to patient care.

(1) Prescription records, physician orders andother records related to any patient care ormedical condition(s) of a patient that aremaintained by a pharmacy in accordance withsection 338.100, RSMo shall be consideredconfidential. Adequate security shall bemaintained over such records in order to pre-vent any indiscriminate or unauthorized useof any written, electronic or verbal communi-cations of confidential information.

(2) Confidential records shall not be releasedto anyone except—

(A) The patient;(B) A health care provider involved in

treatment activities of the patient;(C) Lawful requests from a court or grand

jury;(D) A person authorized by a court order;(E) Any other person or entity authorized

by a patient to receive such information;(F) For the transfer of medical or prescrip-

tion information between pharmacists as pro-vided by law;

(G) Government agencies acting within thescope of their statutory authority; or

(H) A person or entity to whom such infor-mation may be disclosed under 45 CFR Parts160, 164 and 165 (the Privacy Standards ofthe Health Insurance Portability and Account-ability Act of 1996).

(3) This rule does not change or otherwisealter the authority of the board, its inspectorsor other authorized designees to review,inspect, copy or take possession of any suchrecords.

(4) Methods to access, transmit, store, ana-lyze, or purge confidential information shallbe implemented using procedures generallyrecognized as secure by experts qualified bytraining and experience. Procedures shall bein place to ensure that purged confidentialinformation cannot be misused or placed intoactive operation without appropriate autho-rization as provided in this rule. Internetconnectivity or remote access tied directly tosystems containing confidential informationmust be secure as provided for in 4 CSR 220-2.085(2)(B).

AUTHORITY: sections 338.100, 338.140 and338.280, RSMo 2000.* This rule originallyfiled as 4 CSR 220-2.300. Original rule filedMay 4, 1995, effective Dec. 30, 1995.Rescinded and readopted: Filed Nov. 1,2000, effective June 30, 2001. Amended:Filed Dec. 15, 2003, effective July 30, 2004.Moved to 20 CSR 2220-2.300, effective Aug.28, 2006.

*Original authority: 338.100, RSMo 1939, amended 1971,1990, 1997, 1999; 338.140, RSMo 1939, amended 1981,1989, 1997; 338.280, RSMo 1951, amended 1971, 1981.

20 CSR 2220-2.400 Compounding Stan-dards of Practice

PURPOSE: This rule defines compoundingand establishes guidelines for the compound-ing of drugs.

(1) Compounding is defined as the prepara-

tion, incorporation, mixing and packaging orlabeling of a drug or device as the result of aprescriber’s prescription or prescription drugorder based on the prescriber/patient/phar-macist relationship in the course of profes-sional practice. Compounding may also bedefined as the preparation, incorporation,mixing and packaging or labeling of a drug ordevice, for the purpose of, or as an incidentto, research, teaching or chemical analysisand not for sale or dispensing purposes.

(2) Manufacturing is defined as the produc-tion, preparation, propagation, conversion,or processing of a drug or device, eitherdirectly or indirectly, by extraction from sub-stances of natural origin or independently bymeans of chemical or biological synthesis,and includes any packaging or repackaging ofthe substance(s) or labeling or relabeling ofits container, and the promotion and market-ing of such drugs or devices.

(3) Batch compounded product is defined asa product compounded in advance of receiptof a prescription or a product compounded ina supply that will be used on more than one(1) dispensing to a patient or patients or anyproduct compounded in excess of the fillingof an individual prescription. A batch is aspecific quantity of product compounded in asingle, discrete process, by the same individ-uals, carried out during one (1) limited timeperiod.

(4) Beyond-use date: A date after which acompounded preparation should not be usedand is determined from the date the prepara-tion is compounded. Because compoundedpreparations are intended for administrationimmediately or following short-term storage,their beyond-use dates must be assignedbased on criteria different from those appliedto assigning expiration dates to manufactureddrug products.

(5) Compounding Area and EquipmentRequirements.

(A) The area(s) used for the compoundingof drugs shall be maintained in a sanitarycondition and shall be free of infestation byinsects, rodents and other vermin. Trash shallbe held and disposed of in a timely and sani-tary manner.

(B) If drug products with special precau-tions for contamination, such as penicillin,are involved in a compounding operation,appropriate measures, including either thededication of equipment for such operationsor the meticulous cleaning of contaminatedequipment prior to its return to inventory,must be utilized in order to prevent cross-contamination.

(C) Equipment used in the compounding ofdrug products shall be of appropriate design,adequate size and suitably located to facilitateoperations for its intended use and for itscleaning and maintenance. Equipment used inthe compounding of drug products shall be ofsuitable composition so that surfaces thatcontact ingredients, in-process materials ordrug products shall not be reactive, additiveor absorptive so as to alter the safety, identity,strength, quality or purity of the drug productbeyond that desired.

(6) Proper controls shall be maintained overdrug products/ingredients, containers andcontainer closures.

(A) Bulk drugs and other materials used inthe compounding of drugs must be stored inadequately labeled containers in a clean, dryarea or, if required, under proper refrigera-tion.

(B) Pharmacists shall only receive, store oruse drug substances for compounding thathave been made and/or distributed by Mis-souri licensed/registered drug distributors.

(C) Pharmacists shall only use nondrugsubstances for compounding that are free ofany contaminants and which maintain fullpotency.

(D) Drug products/ingredients, containersand container closures used in the compound-ing of drugs shall be handled and stored in amanner to prevent contamination.

(E) Drug product/ingredient containersand container closures shall not be reactive,additive or absorptive so as to alter the safety,identity, strength, quality or purity of thecompounded drug beyond the desired result.Container systems shall provide adequateprotection against foreseeable external factorsin storage and use that can cause deteriora-tion or contamination of the compoundeddrug product.

(7) Appropriate quality control measuresshall be maintained by the pharmacy and itsstaff over compounding methods.

(A) Such methods shall include the follow-ing and shall be followed in the execution ofthe drug compounding process. A separatelog shall be maintained which includes:

1. Methods for the compounding of drugproducts to insure that the finished productshave the identity, strength, quality and puritythey purport or are represented to possess;

2. Date of compounding;3. Identity of the compounding pharma-

cist;4. A listing of the drug products/ingre-

dients and their amounts by weight or vol-ume;

5. Description of the compounding

process and the order of drug product/ingre-dient addition, if necessary for proper com-pounding;

6. The identity of the source, lot numberand the beyond-use date of each drug prod-uct/ingredient, as well as an in-house lotnumber and a beyond-use date for bulk com-pounded products; and

7. An identifying prescription numberor a readily retrievable unique identifier forwhich the compound was dispensed.

(B) Information related to and the methodsof compounding shall be available uponrequest.

(C) Pharmacists may compound drugs inlimited quantities prior to receiving a validprescription based on a history of receivingvalid prescriptions that have been generatedsolely with an established pharmacist/patient/prescriber relationship.

1. The compounding of drug products inanticipation of receiving prescriptions with-out an appropriate history of such prescrip-tions on file or a documented need, shall beconsidered manufacturing instead of com-pounding of the drug(s) involved. Limitedquantities, for purposes of this rule, are fur-ther defined as an amount of batched productthat represents a three (3)-month supply.

2. Creams, ointments, lotions, linimentsor other compounded products intended forexternal use may be batched in the same man-ner as provided for in paragraph (5)(C)1. ofthis rule that represents a one (1)-year supply.

(D) Any excess compounded products shallbe stored and accounted for under conditionsdictated by its composition and stability char-acteristics to insure its strength, quality andpurity. Excess product shall be labeled withthe name of the drug(s), an in-house lot num-ber and beyond-use date.

(E) Records as outlined in this rule shall beretained and made readily retrievable forinspection for two (2) years from the date ofcompounding.

(F) The actual name of each active or ther-apeutic ingredient contained in a compoundshall be listed on the container of any productprovided to a consumer.

(8) Management of Compounding.(A) A pharmacist dispensing any com-

pounded drug is responsible for ensuring thatthe product has been prepared, labeled, con-trolled, stored, dispensed and distributedproperly. The pharmacist is responsible forensuring that quality is built into the prepara-tion of products, with key factors including atleast the following general principles:

1. Personnel are capable and qualified toperform their assigned duties;

2. Ingredients used in compounding

have their expected identity, quality and puri-ty. Drug components must meet compendialstandards or maintain a certificate of analysison file when bulk drug substances areinvolved. Visual inspection of bulk drug sub-stances must be performed;

3. Reasonable assurance that processesare always carried out as intended or speci-fied;

4. Preparation conditions and proce-dures are adequate for preventing mix-ups orother errors; and

5. All finished products, as a conditionof release, must be individually inspected forevidence of visible particulates or other for-eign matter and for container-closure integri-ty and any other apparent visual defects.

(B) The pharmacy is responsible for devel-oping a drug monitoring system for com-pounded products. The outcome monitoringsystem shall provide readily retrievable infor-mation suitable for the evaluation of the qual-ity of pharmaceutical services. This shallinclude but not be limited to reported infec-tion rates, incidence of adverse drug reac-tions, incidence of recalls and complaintsfrom prescribers or clients.

(C) A recall must be initiated when a prod-uct is deemed to be misbranded or adulterat-ed. The pharmacy shall notify the prescriberof the nature of the recall, the problem(s)identified and any recommended actions toensure public health and safety.

1. In cases where the compounded prod-uct has the potential to harm the patient, thesame recall notification, as provided for inthis subsection, shall be provided to allpatients that have received the recalled com-pounded product(s).

2. Any recall initiated by a pharmacyshall be reported, in writing, to the boardwithin three (3) business days.

(9) Compounding of drug products that arecommercially available in the marketplace orthat are essentially copies of commerciallyavailable Federal Drug Administration (FDA)approved drug products is prohibited. Thereshall be sufficient documentation within theprescription record of the pharmacy of thespecific medical need for a particular varia-tion of a commercially available compound.

(10) Any alteration, change or modificationto the contents of a commercially manufac-tured over-the-counter product shall require aprescription or prescription drug order froman authorized prescriber. The compoundingof any drug product to be sold without a pre-scription is prohibited.

(11) Any person shown at any time, either by



medical examination or pharmacist determi-nation, to have an apparent illness or openlesion(s) that may adversely affect the safetyor quality of a drug product being compound-ed shall be excluded from direct contact withdrug products/ingredients, drug product con-tainers, container closures and in-processmaterials, until the condition is corrected ordetermined by competent medical personnelnot to jeopardize the safety or quality of theproducts being compounded.

(12) Pharmacists shall not offer compoundeddrug products to other pharmacies, practi-tioners or commercial entities for subsequentresale or administration, except in the courseof professional practice for a prescriber toadminister to an individual patient by pre-scription. A pharmacist or pharmacy mayadvertise or otherwise provide informationconcerning the provision of compoundingservices; however, no pharmacist or pharma-cy shall attempt to solicit business by makingspecific claims about compounded products.

(13) In addition to the requirements outlinedin this rule, all standards and requirements asoutlined in 4 CSR 220-2.200 Sterile Pharma-ceuticals must be adhered to whenever com-pounding involves the need for aseptic proce-dures or requires the use of or results in anintended sterile pharmaceutical product.

AUTHORITY: sections 338.010, 338.140,338.240 and 338.280, RSMo 2000.* Thisrule originally filed as 4 CSR 220-2.400.Original rule filed Aug. 25, 1995, effectiveApril 30, 1996. Amended: Filed Dec. 3,2002, effective July 30, 2003. Moved to 20CSR 2220-2.400, effective Aug. 28, 2006.

*Original authority: 338.010, RSMo 1939, amended 1951,1989, 1990; 338.140, RSMo 1939, amended 1981, 1989,1997; 338.240, RSMo 1951; and 338.280, RSMo 1951,amended 1971, 1981.

20 CSR 2220-2.450 Fingerprint Require-ments(Rescinded August 30, 2013)

AUTHORITY: sections 338.140 and 338.280,RSMo 2000. This rule originally filed as 4CSR 220-2.450. Original rule filed Jan. 6,1997, effective July 30, 1997. Amended:Filed April 23, 1998, effective Nov. 30, 1998.Moved to 20 CSR 2220-2.450, effective Aug.28, 2006. Amended: Filed Aug. 21, 2006,effective April 30, 2007. Amended: Filed Feb.6, 2008, effective Aug. 30, 2008. Rescinded:Filed Jan. 10, 2013, effective Aug. 30, 2013.

20 CSR 2220-2.500 Nuclear Pharmacy—Minimum Standards for Operation

PURPOSE: This rule defines minimum stan-dards for the operation of nuclear pharma-cies, a specialty of pharmacy practice. Thisregulation is intended to supplement otherregulations of the Board of Pharmacy, as wellas those of other state and/or federal agen-cies.

(1) Definitions.(A) The “practice of nuclear pharmacy”

means a patient-oriented service that embod-ies the scientific knowledge and professionaljudgment required to improve and promotehealth through the assurance of the safe andefficacious use of radiopharmaceuticals andother drugs.

(B) The term “nuclear pharmacy” meansthe location where radioactive drugs, andchemicals within the classification of legenddrugs, are compounded, dispensed, stored,or sold. The term “nuclear pharmacy” doesnot include the nuclear medicine facilities ofhospitals or clinics where radiopharmaceuti-cals are compounded or dispensed to patientsunder the supervision of a licensed physician,authorized by the Nuclear Regulatory Com-mission and/or the Missouri Department ofHealth.

(C) A “qualified nuclear pharmacist”means a pharmacist who holds a currentlicense issued by the board and who is eithercertified as a nuclear pharmacist by the Boardof Pharmaceutical Specialties, a pharmacistwho meets minimal standards of training forstatus as an authorized nuclear pharmacist oran authorized user of radioactive material, asspecified by the Nuclear Regulatory Commis-sion or by agencies of states that maintaincertification agreements with the NuclearRegulatory Commission.

(D) “Radiopharmaceutical services”means the procurement, storage, handling,compounding, preparation, labeling, qualitycontrol testing, dispensing, distribution,transfer, record keeping and disposal ofradiochemicals, radiopharmaceuticals andancillary drugs, and also includes qualityassurance procedures, radiological healthactivities, any consulting activities associatedwith the use of radiopharmaceuticals, healthphysics, and any other activities required forprovision of pharmaceutical care.

(E) “Quality control testing” means theperformance of appropriate chemical,biological and physical tests on compoundedradiopharmaceuticals and the interpretationof the resulting data to determine their suit-ability for use in humans and animals.

(F) “Quality assurance procedures” meansall activities necessary to assure the quality ofthe process used to provide radiopharmaceu-

tical services, including authentication ofproduct history and maintenance of allrecords as required by pertinent regulatoryagencies.

(G) “Authentication of product history”means identifying the purchasing source, theultimate fate, and any intermediate handlingof any component of a radiopharmaceuticalor other drug.

(H) “Radiopharmaceutical” means anydrug which exhibits spontaneous disintegra-tion of unstable nuclei with the emission ofnuclear particles or photons and includes anynonradioactive reagent kit or nuclide genera-tor which is intended to be used in the prepa-ration of any such substance but does notinclude drugs such as carbon-containingcompounds or potassium-containing saltswhich contain trace quantities of naturallyoccurring radionuclides. The term “radio-pharmaceutical” also includes any biologicalproduct which is labeled with a radionuclideor intended solely to be labeled with aradionuclide.

(2) General Requirements for PharmaciesProviding Radiopharmaceutical Services.

(A) No person may receive, acquire, pos-sess, compound or dispense any radiophar-maceutical except in accordance with the pro-visions of this rule and the conditions of rulesand regulations promulgated by the NuclearRegulatory Commission and/or the MissouriDepartment of Health. The requirements ofthis rule are in addition to and not in substi-tution of, other applicable statutes and regu-lations administered by the State Board ofPharmacy or the Missouri Department ofHealth.

(B) Nothing in this rule shall be construedas requiring a licensed physician to obtain aseparate license as a nuclear pharmacist,when the use of radiopharmaceuticals is lim-ited to the diagnosis and treatment of patientsunder the supervision of the physician.

(C) Nothing in this rule shall be construedas requiring a licensed clinical laboratory,which is also licensed by the Nuclear Regula-tory Commission and/or the MissouriDepartment of Health to handle radioactivematerials, to obtain the services of a nuclearpharmacist, or to have a pharmacy permit,unless the laboratory is engaged in the com-mercial sale or resale of radiopharmaceuti-cals.

(D) Nothing in this rule shall be construedto require a department of nuclear medicinewhich is located in a hospital, which has aphysician board certified in his/her specialtyand which is licensed by the Nuclear Regula-tory Commission and/or the MissouriDepartment of Health to handle radioactivematerials, to obtain the services of a pharma-cist or to have a nuclear pharmacy license forradiopharmaceutical preparation and distribu-


Secretary of State


tion to patients within that institution.

(3) Permits.(A) A permit to operate a nuclear pharma-

cy shall only be issued to a person who is, orwho employs, a qualified nuclear pharmacist.All personnel performing tasks in the prepa-ration and distribution of radiopharmaceuti-cals and ancillary drugs shall be under thedirect supervision of a qualified nuclear phar-macist, who shall be in personal attendance.The pharmacist-in-charge shall be responsi-ble for all operations of the pharmacy.

(B) The permit to operate a nuclear pharma-cy is effective only so long as the pharmacyalso holds a current Nuclear RegulatoryCommission and/or Missouri Department ofHealth license. Copies of inspection reportsshall be made available upon request to theboard for inspection.

(C) Any nuclear pharmacy which provides(transfers) product outside of a patient specif-ic prescription service must be licensed as adrug distributor in order to provide a productfor a prescriber’s use.

(4) Space, Security, Record Keeping andEquipment.

(A) Nuclear pharmacies shall have ade-quate space and equipment, commensuratewith the scope of services required and pro-vided and as required by the Nuclear Regula-tory Commission. All pharmacies handlingradiopharmaceuticals shall include, but notbe limited to, the following areas:

1. Radiopharmaceutical preparation/dis-pensing area;

2. Radioactive material shipping/receiv-ing area;

3. Radioactive material storage area; and 4. Radioactive waste decay area.

(B) The nuclear pharmacy professionalservice area shall be secured against unautho-rized personnel and must be totally enclosedand lockable.

(C) Nuclear pharmacies shall maintainrecords of acquisition, inventory and disposi-tion of all radioactive drugs and otherradioactive materials in accordance with StateBoard of Pharmacy, Nuclear RegulatoryCommission and/or Missouri Department ofHealth statutes and regulations.

(D) Nuclear pharmacies shall compoundand dispense radiopharmaceuticals in accor-dance with accepted standards of radiophar-maceutical quality assurance. The StateBoard of Pharmacy recognizes that the prepa-ration of radiopharmaceuticals involves thecompounding skills of the nuclear pharmacistto assure that the final drug product meetsaccepted professional standards of purity andquality.

(E) A nuclear pharmacy shall have avail-

able the following resources:1. A vertical laminar airflow hood that

is annually certified to assure aseptic condi-tions within the working areas;

2. A sanitary work area that is designedto avoid outside traffic and outside airflowand that is ventilated so that it does not inter-fere with sanitary conditions. The sanitarywork area shall not be used for bulk storageof supplies or other materials;

3. A sink located nearby that is suitablefor cleaning purposes;

4. A current policy and procedure man-ual that includes the following subjects:

A. Sanitation;B. Storage;C. Dispensing;D. Labeling;E. Record keeping;F. Recall procedures;G. Responsibilities and duties of sup-

portive personnel;H. Training and education in aseptic

technique; andI. Compounding procedures.

(5) Dispensing, Packaging, Labeling.(A) A radiopharmaceutical shall be dis-

pensed only to a licensed physician autho-rized by the Nuclear Regulatory Commissionand/or the Missouri Department of Health topossess, use and administer such drug. Aradiopharmaceutical shall be dispensed onlyupon receipt of a prescription or medicationorder from such licensed physician. Exceptthat a radiopharmaceutical may be transferredto a person who is authorized to possess anduse the drug for nonclinical applications.

(B) Radioactive drugs are to be dispensedonly upon a non-refillable prescriptionorder from a licensed physician or thephysician’s designated agent. Upon receiv-ing an oral prescription order for a radio-pharmaceutical, the nuclear pharmacy shallimmediately have the prescription orderreduced to writing or recorded in a dataprocessing system. The order must be takenby a pharmacist, intern pharmacist, nuclearmedicine technologist or designated agents.Nuclear medicine technologists may onlyreceive prescription orders for diagnosticradiopharmaceuticals, and all such prescrip-tions must be reviewed and initialed by thepharmacist. The prescription record shallcontain all information as required in 4 CSR220-2.018 Prescription Requirements andshall also include:

1. The date of dispensing and the cali-bration time of the radiopharmaceutical; and

2. The name of the procedure.(C) The immediate outer container shield

of a radiopharmaceutical to be dispensed

shall be labeled with—1. The name and address of the pharma-

cy;2. The name of the prescriber;3. The date of dispensing;4. The serial number assigned to the

order for the radiopharmaceutical;5. The standard radiation symbol;6. The words “Caution Radioactive

Material”;7. The name of the procedure;8. The radionuclide and chemical form;9. The amount of radioactivity and the

calibration date and time;10. If a liquid, the volume;11. If a solid, the number of items or

weight;12. If a gas, the number of ampules or

vials;13. Molybdenum-99 content to United

States Pharmacopoeia (USP) limits; and14. The patient name or the words

“Physician’s Use Only” in the absence of apatient name. When the prescription is for atherapeutic or blood-product pharmaceutical,the patient name shall appear on the label.The requirements of this paragraph shall bemet when the name of the patient is readilyretrievable from the physician upon demand.

(D) The immediate inner container label ofa radiopharmaceutical to be dispensed shallbe labeled with—

1. The standard radiation symbol;2. The words “Caution Radioactive

Material”;3. The identity of the radionuclide; and4. The serial number of the radiophar-

maceutical.(E) When a radiopharmaceutical is dis-

pensed under the authority of an Investi-gational New Drug Application (IND), thenuclear pharmacy records shall include aninvestigator’s protocol for the preparation ofthe radiopharmaceutical, a copy of the Insti-tutional Review Board approval form (or let-ter) and a letter from the manufacturer (spon-sor) indicating that the physician requestingthe radiopharmaceutical is a qualified investi-gator.

(6) Reference Manuals.(A) Each nuclear pharmacy shall have a

copy of the Missouri Pharmacy Practice Actand current regulations under the act; onerecognized text in nuclear pharmacy, and acurrent copy of state and federal regulationsgoverning the safe storage, handling, use, dis-pensing, transport and disposal of radioactivematerial.

(7) Any preparation of Positron EmissionTomographic (PET) radiopharmaceuticals




Secretary of State


shall comply with 4 CSR 220-2.200 SterilePharmaceuticals and with applicable USPstandards.

AUTHORITY: sections 338.210, 338.240,338.250, 338.280, 338.330(3), RSMo 1994and 338.220 and 338.350, RSMo Supp.1997.* This rule originally filed as 4 CSR220-2.500. Original rule filed Sept. 2, 1997,effective April 30, 1998. Moved to 20 CSR2220-2.500, effective Aug. 28, 2006.

*Original authority: 338.210, RSMo 1951; 338.220, RSMo1951, amended 1969, 1981, 1989, 1997; 338.240, RSMo1951; 338.250, RSMo 1951, amended 1990; 338.280,RSMo 1951, amended 1971, 1981; 338.330, RSMo 1989,amended 1993; and 338.350, RSMo 1989, amended 1993,1995.

20 CSR 2220-2.600 Standards of Opera-tion for a Class F: Renal Dialysis Pharma-cy

PURPOSE: This rule incorporates the provi-sions of SB 141 and defines minimum stan-dards for a Class F: Renal Dialysis Pharma-cy.

(1) A Class F pharmacy (renal dialysis) shallbe limited in scope to the provision of dialysisproducts and supplies to persons with chronickidney failure for self-administration at theperson’s home or specified address. Pharma-cy services and dialysis supplies and productsprovided by a Class F pharmacy shall be lim-ited to the distribution and delivery of drugsand devices as provided within this rule. Alldrugs and devices must be ordered by anauthorized prescriber for administration ordelivery to a person with chronic kidney fail-ure for self-administration at the person’shome or specified address. All dialysis sup-plies and products provided by a Class Fpharmacy shall be prepackaged and shall becovered by an approved New Drug Applica-tion (NDA) or 510(k) application issued bythe Food and Drug Administration (FDA).

(2) A Class F pharmacy shall maintain apharmacist-in-charge on a consultant basiswho shall review pharmacy operations atleast weekly. The pharmacist-in-charge of aClass F pharmacy will be responsible for thefollowing requirements:

(A) Ensure that the use of legend drugsand devices that are provided to a person forthe treatment of chronic kidney disease forself-administration at the person’s home orspecified address shall be under the profes-sional supervision of an appropriate practi-tioner licensed under Missouri law.

(B) Ensure that only drugs and devices that

have been ordered by an authorized prescriberand are included on the list of approved for-mulary drugs and devices are provided topatients;

(C) Ensure that no drugs or devices shallbe dispensed to a patient until adequate train-ing in the proper use and administration ofsuch products has been completed;

(D) Ensure that proper documentation ofdrug and device distributions and deliveriesare maintained by the Class F pharmacy andare made available upon request to practition-ers involved in the care of the patient and toboard of pharmacy representatives;

(E) Maintain a policy and procedure man-ual that shall be available for inspection byboard of pharmacy personnel. The manualshall include a quality assurance programwith which to monitor the qualifications,training and performance of personnel; and

(F) The pharmacist-in-charge shall beresponsible for the drug/device delivery sys-tem and shall establish a written protocol forthe implementation of the delivery systemincluding methods for supervisingdrug/device deliveries to patients of the phar-macy.

1. Any written protocols shall be avail-able for inspection by board of pharmacy per-sonnel.

2. Any changes to the policy and proce-dure manual or to written protocols must beapproved by the pharmacist-in-charge.

(3) Drug Formulary List/Device List. Thepharmacy shall submit a list of drugs and/ordevices which must be approved by the boardof pharmacy.

(4) A Class F pharmacy shall deliver prod-ucts to a person with chronic kidney failureonly upon the receipt of a valid prescriptionfrom an authorized prescriber specifying orincluding:

(A) Documents that the intended recipientwill require such products for the appropriatetreatment of the disease and that the intendedrecipient has been trained in home dialysistherapy;

(B) The duration of the prescriber’s order,not to exceed one (1) year, including allauthorized refills; and

(C) The name and product code of eachproduct prescribed and the quantity pre-scribed.

(5) Personnel of the pharmacy shall assemblethe products to be delivered pursuant to theprescriber’s order(s). In assembling suchproducts for delivery, the pharmacy shall takesteps necessary to assure the following:

(A) The code numbers and quantities of the

products assembled match the code numbersidentified in the prescriber’s order(s);

(B) Any products bearing an expirationdate have a minimum of three (3) full monthsof shelf-life remaining;

(C) A visual inspection of all drugs anddevices for compliance with the prescriber’sorder(s) and with all labeling requirements asset forth in 338.059, RSMo. Manufacturersealed case lots shall be labeled with thename of the patient, date, and a control num-ber that serves as a unique patient identifiernumber; and

(D) Products ordered by a prescriber andprovided to patients of the pharmacy shall bedelivered either by personnel of the pharmacyor by a carrier authorized by the pharmacy.

1. Upon the delivery to patients of anydrugs/devices, pharmacy personnel or theapproved carrier shall confirm receipt by thepatient or the patient’s designee and that thenumber of units delivered equals the numberof units identified by documentation suppliedby the pharmacy.

(6) Class F pharmacies shall comply with allof the following:

(A) The license of the pharmacy shall bedisplayed in plain view at the pharmacy loca-tion;

(B) The pharmacy shall be open such hoursas are necessary to safely and effectively dis-pense and deliver supplies to those personsdesignated by the applicable prescriber;

(C) The pharmacy must maintain sufficientspace and storage capabilities as necessary tocarry out its operations; and

(D) All drugs and/or devices shall beproperly identified and any outdated, mis-branded or adulterated items shall be segre-gated from the active inventory within aclearly separate and defined area and shall beheld separately until the item is destroyed orreturned to a licensed drug distributor.

AUTHORITY: sections 338.140 and 338.220,RSMo Supp. 1997 and 338.280, RSMo1994.* This rule originally filed as 4 CSR220-2.600. Original rule filed Jan. 20, 1998,effective Aug. 30, 1998. Moved to 20 CSR220-2.600, effective Aug. 28, 2006.

*Original authority: 338.140, RSMo 1939, amended 1981,1989, 1997; 338.220, RSMo 1951, amended 1969, 1981,1989, 1997; and 338.280, RSMo 1951, amended 1971,1981.

20 CSR 2220-2.650 Standards of Opera-tion for a Class J: Shared Services Phar-macy

PURPOSE: The purpose of this rule is to estab-lish standards for Class J: Shared Services



pharmacies.

(1) Class J: Shared Services: A Class J SharedServices permit is required if two (2) or morepharmacies are engaged in, or have an arrange-ment to provide, functions related to the prac-tice of pharmacy for or on behalf of the otherpharmacy. These functions may include, butare not limited to: prescription/order receipt,prescription/order clarification or modifica-tion, obtaining prescriber authorization, dataentry, compounding, dispensing, pharmacistverification, patient counseling, patient profilemaintenance, medication therapy services,medication administration, drug utilizationreview (DUR), and obtaining refill authoriza-tion. Both pharmacies participating in theshared services arrangement must have a ClassJ permit.

(A) Pharmacies may perform Class-JShared Services provided the parties—

1. Have the same owner, or have a writ-ten contract outlining the services to be pro-vided and the responsibilities of each party infulfilling the terms of said contract in compli-ance with federal and state laws and regula-tions;

2. Maintain a separate Class-J classifica-tion for each location involved in providingshared services; and

3. Either share a common database orallow access to each pharmacy’s electronicmedication or prescription records. The accessmust provide real-time, online access to thepatient’s complete profile for the pharmaciesinvolved.

(B) Class-J pharmacies operating in com-pliance with this section are exempt from therequirements of 20 CSR 2220-2.120 and 20CSR 2220-6.030(4) when transferring pre-scription information between themselves. AClass-J permit is not required to transfer anindividual prescription as authorized by 20CSR 2220-2.120 pursuant to a request by thepatient or the patient’s authorized designee.

(C) The parties performing Class-J Sharedservices shall maintain a detailed writtendescription of authorized shared services thatincludes the name, address, and permit num-ber(s) of all pharmacies involved. The partiesmust maintain a current and accurate policyand procedure manual that includes, but isnot limited to, the following:

1. Policies and procedures that identifythe duties of each pharmacy including anyfunctions identified in section (1);

2. A mechanism for tracking the pre-scription or medication order during each stepin the process;

3. Security provisions for protecting theconfidentiality and integrity of patient infor-mation;

4. Policies and procedures to ensure thesafe and appropriate delivery of prescriptiondrugs in compliance with 20 CSR 2220-2.013; and

5. A designation of the pharmacyresponsible for offering patient counseling asrequired by 20 CSR 2220-2.190 and federallaw. For purposes of section 338.059, RSMo,either the name and address of the pharmacyresponsible for offering patient counseling orthe pharmacy responsible for dispensing tothe patient may be listed on the label as des-ignated by the pharmacies by contract.

(D) Each pharmacy involved in a Class-Jarrangement must maintain a quality assur-ance program that is designed to objectivelyand systematically monitor and evaluate thequality and appropriateness of pharmacy ser-vices and resolve identified problems.

(E) Compounding may only be performedpursuant to a Class-J pharmacy arrangementpursuant to a patient-specific prescription orin anticipation of a patient-specific prescrip-tion as authorized by 20 CSR 2220-2.200 andthe rules of the board.

(F) A Class-J permit is not required forpharmacists performing non-dispensingactivities authorized by 20 CSR 2220-6.050outside of a licensed pharmacy.

(2) A Class J Shared services permit shall notbe required if a completed and labeled pre-scription is delivered from a Missouri licensedpharmacy to another Missouri licensed phar-macy for administration by a pharmacist orother licensed health care professional to thepatient on the same premises or physical loca-tion as the pharmacy.

(A) The exemption recognized in this sub-section only applies if a completed and labeledprescription is delivered to the receiving phar-macy.

(B) If additional manipulation or com-pounding is required by the receiving phar-macy, receipt of a prescription or order isrequired and the receiving pharmacy mustdispense the product as their own prescrip-tion/order. All prescription requirements,record keeping, compounding, and labelingrequirements must be met.

(C) The receiving pharmacy must maintaindocumentation of the medication received,the name and address of the pharmacy pro-viding the medication, the date of receipt,and the patient’s name.

(D) The receiving pharmacy is responsiblefor ensuring compliance with all applicablepatient counseling requirements.

(E) For purposes of this rule, administra-tion is defined as applying or introducingmedication to the body of a patient, whetherby injection, infusion, inhalation, ingestion,

or other means.(F) Medication administered by a pharma-

cist must be performed in compliance with allapplicable provisions of law.

(G) Notwithstanding any other provision ofthis rule, licensees shall comply with allapplicable controlled substance laws and regu-lations, including, but not limited to, allapplicable security and record keepingrequirements.

(3) A pharmacy participating in Class-J sharedservices with a pharmacy that is not undercommon ownership must notify patients thathis/her prescription or medication order maybe filled or compounded by another pharmacy.

(4) All records required by this rule includingall policy and procedure manuals, contracts,quality assurance documentation, or otheragreements must be maintained for two (2)years and must be made available to the boardor its representative upon request.

AUTHORITY: sections 338.140, 338.210,338.220, 338.240, and 338.280, RSMo2016.* This rule originally filed as 4 CSR220-2.650. Original rule filed Nov. 30, 2001,effective June 30, 2002. Amended: Filed Dec.3, 2002, effective June 30, 2003. Moved to 20CSR 2220-2.650, effective Aug. 28, 2006.Emergency amendment filed July 27, 2017,effective Aug. 6, 2017, expired Feb. 22, 2018.Amended: Filed July 27, 2017, effective Jan.30, 2018.

*Original authority: 338.140, RSMo 1939, amended 1981,1989, 1997, 2011; 338.210, RSMo 1951, amended 2001,2011; 338.220, RSMo 1951, amended 1969, 1981, 1989,1997, 1999, 2001, 2004, 2007, 2009, 2011, 2013, 2014;338.240, RSMo 1951, amended 2011; and 338.280, RSMo1951, amended 1971, 1981.

20 CSR 2220-2.675 Standards of Opera-tion/Licensure for Class L VeterinaryPharmacies

PURPOSE: This rule defines standards for aClass L veterinary pharmacy.

(1) A Class A or a Class L pharmacy permitshall be required for any entity engaged in thesale, dispensing, or filling of a legend drugfor use in animals that must only be dis-pensed by prescription under state or federallaw. For purposes of this rule, a legend drugshall be defined as provided by 21 USC sec-tion 353.

(2) Class A Pharmacies. Class A permitholders shall comply with all laws/rulesapplicable to Class A pharmacies, provided aClass A pharmacy shall comply with sections(7) and (8) of this rule when legend drugs are


Secretary of State


dispensed for animal use.

(3) Class L Pharmacies. A Class L pharmacyshall dispense, sell, or provide legend drugsonly for animal use. Except as otherwise pro-vided in this rule, a Class L pharmacy shallcomply with all applicable state and federalpharmacy and controlled substance laws/rulesincluding, but not limited to, all applicableprovisions of Chapter 338, RSMo, and therules of the board.

(4) Pharmacy Operations. A Class L pharma-cy shall comply with 20 CSR 2220-2.010,with the following allowed modifications:

(A) The pharmacy permit shall be dis-played in plain view at the pharmacy loca-tion;

(B) The pharmacy shall maintain sufficientspace, equipment, and storage capabilities asnecessary to carry out its operations;

(C) Legend drugs shall be properly identi-fied and stored in a defined area within thepharmacy;

(D) Legend drugs shall be stored in a cleanand sanitary designated area and within tem-perature requirements as provided for by themanufacturer or the latest edition of the Unit-ed States Pharmacopoeia (USP);

(E) The pharmacy shall maintain a currentreference manual related to veterinary drugsthat complies with 20 CSR 2220-2.010(1)(D);

(F) Appropriate sewage disposal must beavailable within the pharmacy and a hot andcold water supply shall be accessible to phar-macy staff. If compounding is performed, thehot and cold water supply shall be locatedwithin the pharmacy;

(G) Pharmacy compounding shall complywith 20 CSR 2220-2.200, 20 CSR 2220-2.400, and all other applicable provisions ofstate/federal law;

(H) All dispensing errors shall be docu-mented in the pharmacy’s records;

(I) Animals shall not be allowed in the des-ignated area where legend drugs are stored ormaintained; and

(J) The pharmacist-in-charge shall be noti-fied within twenty-four (24) hours after a dis-pensing error is learned by pharmacy staff.Documentation of notification shall be main-tained in the pharmacy’s prescription records.

(5) A Class L pharmacy shall designate apharmacist-in-charge as required by 20 CSR2220-2.010(1)(M). The pharmacist-in-chargeshall be responsible for supervising pharmacyoperations and ensuring compliance with theprovisions of this rule and all applicablestate/federal laws. Except as otherwise pro-vided in this rule, the pharmacist-in-chargeshall also—

(A) Ensure legend drugs are only sold, dis-pensed, or filled by the pharmacy for animaluse;

(B) Ensure legend drugs have beenordered/prescribed by an authorized pre-scriber; and

(C) Maintain a policy and procedure man-ual for pharmacy operations. The policy andprocedure manual shall be reviewed annuallyby the pharmacist-in-charge. The manualshall be available for inspection by board per-sonnel and shall include policies and proce-dures for:

1. Accepting, compounding, dispensing,or filling prescriptions;

2. Accepting, dispensing, or filling pre-scriptions in the pharmacist’s absence;

3. Drug storage and security;4. Handling drug recalls;5. Procedures for offering patient/client

counseling;6. If applicable, procedures for dispens-

ing or providing prescriptions in a pharma-cist’s absence pursuant to section (8) of thisrule;

7. Contacting the pharmacist-in-chargefor consultation during the pharmacy’s busi-ness operations or in the event of an emer-gency; and

8. Reporting and handling dispensingerrors. The pharmacist-in-charge shall benotified of a dispensing error within twenty-four (24) hours after the error is learned bypharmacy staff. Policies/procedures shallinclude the manner of notification.

(6) A pharmacist shall not be required to bephysically present on-site during the businessoperations of a Class L pharmacy if the phar-macist-in-charge reviews the activities andrecords of the pharmacy operations on amonthly basis to ensure compliance with thisrule. This exemption shall not apply if thepharmacy sells, dispenses, or otherwise pro-vides controlled substances. The date of thepharmacist-in-charge review shall be docu-mented and maintained at the pharmacy.

(7) To be valid for purposes of dispensing,legend drug prescriptions for animal use shallconform to all requirements of sections338.056 and 338.196, RSMo, and shall con-tain the following:

(A) The date issued;(B) The client’s/owner’s name and the

class, species, or identification of the animal,herd, flock, pen, lot, or other group beingtreated;

(C) The prescriber’s name, if an oral pre-scription, or signature, if a written prescrip-tion;

(D) Name, strength, and dosage form ofdrug and directions for use;

(E) The number of refills, when applica-ble;

(F) The quantity prescribed in weight, vol-ume, or number of units;

(G) The address of the prescriber and thepatient when the prescription is for a con-trolled substance;

(H) Whether generic substitution has beenauthorized;

(I) The prescriber’s Drug EnforcementAdministration (DEA) number when the pre-scription is for a controlled substance; and

(J) Controlled substance prescriptions shallcomply with all requirements of federal andstate controlled substance laws.

(8) Dispensing. A Class L pharmacy mayaccept, fill, enter, dispense, or otherwise pro-vide non-controlled legend drugs for animaluse in the absence of a pharmacist, providedthe pharmacist-in-charge shall review the pre-scription record for each such prescription ona monthly basis. The review shall be docu-mented as provided in section (6) of this rule.For purposes of 20 CSR 2220-2.010(3), thedispensing pharmacist shall be identified asthe pharmacist-in-charge unless dispensed byanother licensed pharmacist.

(A) Legend drugs may only be compound-ed for use in animals when a pharmacist ispresent on site.

(B) Clients must be offered an opportunityto consult with a pharmacist as required by20 CSR 2220-2.190. If the pharmacist is notpresent on site, a written offer to counselwith a contact telephone number for a phar-macist shall be supplied with the medication.

(9) Labeling. Prescriptions must be labeledas required by section 338.059, RSMo. Pre-scription labels may be manually written andnumbered and shall include:

(A) The class, species, or identification ofthe animal, herd, flock, pen, lot, or othergroup being treated; and

(B) If applicable, the veterinarian’s speci-fied withdrawal, withholding, or discard timefor meat, milk, eggs, or any other food whichmight be derived from the treated animal(s).

(10) Records. Class L pharmacy records shallbe maintained as required by Chapter 338,RSMo, and the rules of the board, including,20 CSR 2220-2.018 and 20 CSR 2220-2.080.

(A) The information specified in section(7) of this rule shall be required and recordedon all handwritten, telephone, oral, and elec-tronically produced prescriptions that areprocessed for dispensing by a pharma-cist/pharmacy. If applicable, prescriptionrecords shall also include the veterinarian’sspecified withdrawal, withholding, or discardtime identified in section (9) of this rule.

(B) Any change or alteration made to the

prescription dispensed based on contact withthe prescriber shall be documented in thepharmacy’s prescription records. This shallinclude, but is not limited to, a change inquantity, directions, number of refills, orauthority to substitute a drug.

(C) The pharmacy’s prescription recordsshall identify any prescription dispensed in apharmacist’s absence pursuant to section (8)of this rule.

(11) A Class L pharmacy shall comply withall applicable state or federal controlled sub-stance laws.

(12) The provisions of this rule shall not beapplicable to the sale of medication for use inanimals that may lawfully be dispensed with-out a prescription nor shall this rule be con-strued to require licensure for entities solelyengaged in selling, dispensing, or providingmedications authorized for dispensing with-out a prescription.

(13) The provisions of this rule shall not pro-hibit or interfere with any legally registeredpractitioner of veterinary medicine in thecompounding, administering, prescribing, ordispensing of their own prescriptions, medi-cine, drug, or pharmaceutical product to beused for animals.

AUTHORITY: sections 338.056, 338.059,338.196, 338.250, 338.280, and 338.343,RSMo 2000, and sections 338.010, 338.055,338.140, 338.150, 338.210, 338.220, and338.240, RSMo Supp. 2011.* Emergency rulefiled Aug. 29, 2011, effective Sept. 8, 2011,expired March 5, 2012. Original rule filedAug. 29, 2011, effective March 30, 2012.

*Original authority: 338.010, RSMo 1939, amended 1951,1989, 1990, 2007, 2009, 2011; 338.055, RSMo 1971,amended 1978, 1981, 1986, 1998, 2001, 2004, 2011;338.056, RSMo 1978, amended 1996; 338.059, RSMo1971, amended 1973, 1978, 1997; 338.140, RSMo 1939,amended 1981, 1989, 1997, 2011; 338.150, RSMo 1939,amended 1951, 1961, 1980, 1981, 2011; 338.196, RSMo1991; 338.210, RSMo 1951, amended 2001, 2011; 338.220,RSMo 1951, amended 1969, 1981, 1989, 1997, 1999,2001, 2004, 2007, 2011; 338.240, RSMo 1951, amended2011; 338.250, RSMo 1951, amended 1990, 1998;338.280, RSMo 1951, amended 1971, 1981; and 338.343,RSMo 1989, amended 1993.

20 CSR 2220-2.700 Pharmacy TechnicianRegistration

PURPOSE: This rule defines the require-ments for pharmacy technician registration.

(1) A pharmacy technician is defined as anyperson who assumes a supportive role underthe direct supervision and responsibility of apharmacist and who is utilized according to

written standards of the employer or the phar-macist-in-charge to perform routine functionsthat do not require the use of professionaljudgement in connection with the receiving,preparing, compounding, distribution, or dis-pensing of medications.

(A) No person shall assume the role of apharmacy technician without first registeringwith the board in accordance with therequirements in section 338.013, RSMo andthis rule. Nothing in this rule shall precludethe use of persons as pharmacy technicianson a temporary basis as long as the individ-ual(s) is registered as or has applied to theboard for registration as a technician inaccordance with 338.013.1 and .2, RSMo.

(B) A person may be employed as a tech-nician once a completed application and therequired fee is received by the board. Theboard will provide either a registration cer-tificate that shall be conspicuously displayedor a letter of disqualification preventing theapplicant’s employment within a pharmacy.

(C) Information required on the applicationshall include, but is not limited to—

1. The name, phone number, and resi-dential address of the applicant;

2. Full-time and part-time addresseswhere the applicant will be employed as atechnician;

3. Information concerning the appli-cant’s compliance with state and federal laws,as well as any violations that could be consid-ered grounds for discipline as outlined in sec-tion 338.013.5, RSMo;

4. One (1) two-inch by two-inch (2" ×2") frontal view portrait photograph of appli-cant; and

5. Proof of fingerprinting as required by20 CSR 2220-2.450.

(D) A copy of the application must bemaintained by the applicant at the site(s) ofemployment during and until notice of regis-tration or disqualification is received by theapplicant and must be readily retrievable forreview by the board of pharmacy or theboard’s representatives.

(2) Registered technicians as well as appli-cants for registration as a technician areresponsible for informing the board in thecase of a changed residential address. Anymail or communications returned to theboard office marked unknown, incorrectaddress, and the like will not be mailed a sec-ond time until the correct address is provid-ed.

(3) Registered technicians as well as appli-cants for registration as a technician shallinform the executive director of the board ofany change in their employment address. The

notification of an employment change mustbe provided in writing to the board no laterthan fifteen (15) days following the effectivedate of the change.

(4) Any person whose name appears on theboard of pharmacy employment disqualifica-tion list shall be barred from employment asa pharmacy technician except as provided insection (5) of this rule.

(A) Information on the disqualification listshall include, at a minimum, the name and lastknown residential address of the person dis-qualified, as well as any previous registrationnumber, the date on which the person’s namewas entered on the list and the date at whichtime the person will again become eligible foremployment in a pharmacy. The board mayplace a person on the disqualification list foran indefinite period of time if the disqualifiedperson fails to maintain a current mailingaddress with the board or fails to communi-cate with the board on a timely basis whencontacted in writing by the board.

(B) Once the board has made a determina-tion to place a person’s name on the disqual-ification list, the board shall notify the personin writing by mailing the notification to theperson’s last known address. The disqualifi-cation notice shall include:

1. The name, address of residence and,if already registered as a technician, the reg-istration number;

2. The reasons for being placed on thedisqualification list;

3. The consequences of the person’sname appearing on the list;

4. The time period of disqualification;5. Any alternative restrictions or provi-

sions for conditional employment, if providedby the board; and

6. The right to appeal the decision of theboard as provided in Chapter 621, RSMo.

(5) Any person whose name appears on thedisqualification list may be employed as apharmacy technician subject to any restric-tions or conditions ordered by the board. Asan alternative to barring an individual fromemployment in a pharmacy, the board mayconsider restricted forms of employment oremployment under special conditions for anyperson who has applied for or holds a regis-tration as a pharmacy technician. Specialconditions may include participation in theboard’s Well-Being Program, as provided in20 CSR 2220-2.175. Any registered techni-cian subject to restrictions or conditions whoviolates any portion of the restrictions orconditions may be further restricted inemployment or have additional conditionsplaced on their registration. The board may



also implement full disqualification on a reg-istrant who has violated any restrictions orconditions.

(6) The letter of notice of intent to disqualifyand the disqualification list shall be consid-ered an open record of the board as well asany notice of appeal or litigation that pertainsto the disqualification and/or conditional reg-istration as a pharmacy technician.

AUTHORITY: sections 338.013 and 338.380,RSMo Supp. 2009, and section 338.140,RSMo 2000.* This rule originally filed as 4CSR 220-2.700. Original rule filed Aug. 21,1998, effective Feb. 28, 1999. Amended:Filed Nov. 13, 2002, effective June 30, 2003.Moved to 20 CSR 2220-2.700, effective Aug.28, 2006. Amended: Filed Aug. 18, 2009,effective March 30, 2010.

*Original authority: 338.013, RSMo 1997, 2004, 2009;338.140, RSMo 1939, amended 1981, 1989, 1997; and338.380, RSMo 2007.

20 CSR 2220-2.800 Vacuum Tube DrugDelivery System

PURPOSE: This rule defines the minimumstandards for a vacuum tube drug deliverysystem utilized in licensed pharmacies.

(1) Vacuum tube systems are for use in thedelivery of drugs to the patient or his/heragent.

(A) Any drug delivery system that utilizesa vacuum tube to deliver drugs outside of alicensed pharmacy must be designed andengineered in such a way as to ensure securi-ty of all drugs and that drugs are deliveredcorrectly and efficiently to the intendedrecipient.

(B) Only systems that are dedicated for thedelivery of drugs from a location within alicensed pharmacy to another location specif-ic for drug delivery and are not connected,combined or attached to other systems shallbe used. Multiple or switchable stationswhere the delivery of drugs could occur atmore than one destination outside of thepharmacy are prohibited.

1. When the pharmacy is closed or thereis no pharmacist on duty, the vacuum tubesystem must be turned off and no drugs shallbe delivered to consumers during these timeperiods.

(C) Any pharmacy, which cannot maintaina direct and identifiable line of sight with theconsumer, must maintain a video camera andaudio system to provide for effective commu-nication between pharmacy personnel andconsumers. It must be a system that will

allow for the appropriate exchange of oral aswell as written communications to facilitatepatient counseling and other matters involvedin the correct transaction or provision ofdrugs.

1. Video monitors used for the properidentification of persons receiving prescrip-tion drugs shall be a minimum of twelveinches (12") wide.

2. Both the video monitor and the audiosystem must be in good working order oroperations utilizing the vacuum tube systemshall cease until appropriate corrections orrepairs are made to the system(s).

3. Backlighting or other factors that mayinhibit video or audio performance must betaken into account when using such systemsto identify recipients of prescription drugs.Positive identification of recipients must bemade before any drug is delivered.

(2) All vacuum tube delivery systemsinstalled after September 1, 1998, shallcomply with the minimum standards setforth in this rule. Any vacuum tube deliverysystem already installed in a pharmacy priorto September 1, 1998, will not be required tocomply with this rule; except that, should thevacuum tube delivery system or any partthereof require replacement, change, orupgrading after September 1, 1998, the sys-tem or any part of the system being replaced,changed or upgraded shall comply with theminimum standards set forth in this rule. Thisexemption does not relieve a pharmacy of itsduty to maintain adequate security measuresas required by 4 CSR 220-2.010(1)(H); nordoes it relieve pharmacists from their duty toprovide patient counseling as required by 4CSR 220-2.190.

AUTHORITY: sections 338.140, RSMo Supp.1997 and 338.280, RSMo 1994.* This ruleoriginally filed as 4 CSR 220-2.800. Origi-nal rule filed Aug. 21, 1998, effective Feb.28, 1999. Moved to 20 CSR 2220-2.800,effective Aug. 28, 2006.


20 CSR 2220-2.900 Automated Dispensingand Storage Systems

PURPOSE: This rule establishes guidelinesfor the use of automated dispensing and stor-age systems.

(1) Automated dispensing and storage sys-tems (hereafter referred to as automated sys-tem or system) are hereby defined to include,

but are not limited to, mechanical systemsthat perform operations or activities, relativeto the storage, packaging or dispensing ofmedications, and which collect, control, andmaintain all transaction information. Suchsystems may be used in pharmacies andwhere a pharmacy permit exists, for main-taining patient care unit medication invento-ries or for a patient profile dispensing system,provided the utilization of such devices isunder the supervision of a pharmacist. Apharmacist is not required to be physicallypresent at the site of the automated pharmacysystem if the system is supervised electroni-cally by a pharmacist. In order to supervisethe system within an ambulatory care setting,the pharmacist must maintain constant visualand auditory communication with the site andfull control of the automated system must bemaintained by the pharmacist and shall not bedelegated to any other person or entity.Supervision of an automated refill patientself-service device requires that a pharmacistemployed by the pharmacy by which thedevice is owned and operated be available atall times during operating hours of the phar-macy.

(A) Documentation shall be maintained bythe owner/operator of an automated systemfor the type of equipment, locations where allsystems are located, identification of all per-sons accessing the automated system, theidentity of persons stocking or restocking thesystem and the pharmacist responsible forchecking the accuracy of medicationsstocked.

(B) Automated systems that are used with-in licensed health care facilities shall be usedonly in settings that ensure medication ordersare reviewed by a pharmacist in accordancewith established policies and procedures andlaws governing the practice of pharmacy. Apharmacist shall control all operations of theautomated system and approve the release ofthe initial dose of a prescription drug order.Subsequent doses from an approved prescrip-tion drug order may be removed from theautomated system after this initial approval.Any change made in the prescription drugorder shall require a new approval by a phar-macist to release the drug.

(C) In ambulatory care settings, a pharma-cist must input all information from a pre-scription or prescription drug order into theelectronic data system utilized for the initia-tion of the dispensing of a drug at a remotesite and maintain proper oversight over theentire dispensing process. A pharmacist shallbe accessible at all times to respond topatient’s or other health professionals’inquiries or requests pertaining to drugs dis-pensed through the use of the automated


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pharmacy system. No prescription shall beprepared or dispensed from a remote auto-mated system unless it is from a prescriberproviding clinical services at the same loca-tion. Labeling of drug containers must be inaccordance with section 338.059, RSMo, andapplication of labels to containers must occurprior to release of the prepared prescriptiondrug from the automated system. Labels shallcontain both the name, address and phonenumber of the supervising pharmacy and theremote dispensing site.

(D) When automated systems are located atremote sites the central pharmacy responsiblefor the operation and supervision of a remotesite must maintain separate and readilyretrievable records of all transactions and pre-scriptions processed by each remote automat-ed system. Remote automated sites must pro-vide the name, address and toll free telephonenumber of the supervising pharmacy dis-played on the automated dispensing system ina prominent location.

(E) Automated systems shall maintain ade-quate security systems and procedures toprevent unauthorized access or use and shallat all times maintain compliance with all stateand federal drug laws including all controlledsubstance requirements and patient confiden-tiality laws.

1. Any remote automated system thatstocks controlled substances must maintain aperpetual inventory from each site.

2. Automated systems in ambulatorycare settings must be located in an area thatwill provide adequate space for private con-sultations to occur and must only be installedwithin the same area utilized by the pre-scriber for the provision of clinical services.

3. Automated refill patient self-servicedevices must be physically attached to thepharmacy so that access to areas used torestock the device are only accessible throughthe pharmacy physical plant by pharmacy per-sonnel.

(F) Restocking of automated systems shallbe done by registered technicians under thesupervision of a pharmacist or by a pharma-cist.

(G) All events involving access to the con-tents of the automated system must be record-ed electronically.

(H) No medication or device shall bereturned directly to the system for reissue orreuse by a person not licensed or registeredby the board of pharmacy.

(I) Quality assurance documentation forthe use and performance of the automatedsystems shall be maintained for a minimumperiod of two (2) years and shall include at aminimum the following:

1. Breach of security of the automatedsystem;

2. Failure of the system to operate cor-rectly along with the frequency of any failuresand the necessary repairs completed;

3. Tests completed to measure the effec-tiveness and accuracy of the system. every six(6) months and whenever any upgrade orchange is made to the system.

(J) Drugs that are repackaged for use inautomated systems at remote locations mustcomply with 20 CSR 2220-2.130 DrugRepackaging requirements. Automated refillpatient self-service devices must comply withall labeling and dispensing laws governing theprovision of medication refills to patients.Products that are considered temperature sen-sitive or products that require further manip-ulation in order to be ready for use by apatient shall not be provided through patientself-service devices, unless the device has thecapability to provide storage conditions incompliance with Food and Drug Administra-tion (FDA) requirements.

(K) If an automated system uses removablecartridges or containers to hold drugs, theprepackaging of the cartridges or containersmust occur at the pharmacy where the origi-nal inventory is maintained unless providedby a FDA approved repackager and who islicensed as a drug distributor. The prepack-aged cartridges or containers may be sent tothe automated system at remote locations tobe loaded into the machine by registeredtechnicians under the supervision of a phar-macist or by a pharmacist provided that—

1. A pharmacist has verified the con-tainer has been properly filled and labeled;

2. The individual containers are trans-ported to the automated system in a secure,tamper-evident container; and

3. The automated system utilizes tech-nologies to ensure that the containers areaccurately loaded in the automated system.

(L) Any pharmacy that maintains an auto-mated system for remote dispensing to ambu-latory patients must maintain a video cameraand audio system to provide for effectivecommunication between pharmacy personneland consumers. It must be a system that willallow for the appropriate exchange of oral aswell as written communications to facilitatepatient counseling as provided in 20 CSR2220-2.190 and other matters involved in thecorrect transaction or provision of drugs.

1. Video monitors used for the properidentification and communication with per-sons receiving prescription drugs shall be aminimum of twelve inches (12") wide andprovided at both the pharmacy and remotelocation for direct visual contact betweenpharmacist and patient.

2. Both the video monitor and the audiosystem must be in good working order oroperations utilizing the automated systemshall cease until appropriate corrections orrepairs are made to the system(s).

3. Backlighting or other factors that mayinhibit video or audio performance must betaken into account when using such systemsto identify recipients of prescription drugs.Positive identification of recipients must bemade before any drug is delivered.

(2) Each automated system shall maintain amanual of policies and procedures that, at aminimum, shall include the following:

(A) System operations that include specificand measurable accountability for safety,security, accuracy, patient confidentiality,access, data retention and retrieval, downtimeprocedures, emergency first dose or refillpatient self-service procedures, inspection ofsystems by pharmacy personnel, installationrequirements, maintenance, medication secu-rity, quality assurance, inventory levels andcontrol, staff education and training and sys-tem set-up and malfunction.

(B) Documentation by the automated sys-tem at remote locations for on-site patientadministration and remote dispensing of med-ications that includes specific identification ofpatients, medications used along with datesand times the system is utilized.

(C) Effective procedures for securing andaccounting for wasted medications or dis-carded medications.

(D) Access to and limits on access (securi-ty levels) to the automated system must bedefined and must comply with applicablestate and federal laws and regulations.

(3) The pharmacist-in-charge is responsiblefor the overall compliance of the automatedsystem in the same manner as other pharmacyoperations as outlined in 4 CSR 220-2.090.In addition, responsibilities will also include:

(A) Establishment of a quality assuranceprogram prior to implementation of an auto-mated system and the supervision of an ongo-ing quality assurance program that monitorsappropriate use and performance of the auto-mated system, which is evidenced by writtenpolicies and procedures developed by thepharmacy;

(B) Assign, discontinue or change accessto the automated system;

(C) Assure that the automated system is ingood working order and accurately providesthe correct strength, dosage form and quanti-ty of a drug prescribed while maintainingappropriate record keeping and security safe-guards.



(D) Procedures used for notifying theboard on a timely basis and other state andfederal agencies, when warranted, of anybreach of security which results in the unau-thorized removal of drugs.

(4) Except where otherwise noted in this rule,all records specified must be retained as apart of the dispensing record of the pharmacyand in accordance with section 338.100,RSMo and board regulations governing theproper maintenance and retrieval of records.

(5) Pharmacies that maintain automated sitesfor dispensing drugs to ambulatory patientsshall maintain a Class J: Shared Service clas-sification on each pharmacy permit involvedin such activity.

(6) The supervising pharmacy shall have suf-ficient pharmacists on duty such that eachpharmacist may supervise no more than three(3) remote sites that are simultaneously opento provide services. An exception to thesupervision limit may be granted by the boardin situations where the provider has docu-mented a need for a pharmacist to superviseadditional remote sites and has demonstratedthat appropriate safeguards are in place toassure proper supervision of each remotesite.

AUTHORITY: sections 338.210 and 338.220,RSMo Supp. 2006 and 338.140 and 338.280,RSMo 2000.* This rule originally filed as 4CSR 220-2.900. Original rule filed Nov. 1,2000, effective June 30, 2001. Amended:Filed Feb. 18, 2003, effective Sept. 30, 2003.Moved to 20 CSR 2220-2.900, effective Aug.28, 2006. Amended: Filed Aug. 21, 2006,effective April 30, 2007.

*Original authority: 338.140, RSMo 1939, amended 1981,1989, 1997; 338.210, RSMo 1951, amended 2001;338.220, RSMo 1951, amended 1969, 1981, 1989, 1997,1999, 2001, 2004; and 338.280, RSMo 1951, amended1971, 1981.

20 CSR 2220-2.950 Automated Filling Sys-tems

PURPOSE: This rule establishes standardsfor automated filling systems.

(1) Definitions. The following definitionsshall be applicable for purposes of this rule:

(A) “Automated filling system”—An auto-mated system used by a pharmacy to assist infilling a prescription drug order by selecting,labeling, filling, or sealing medication fordispensing. An “automated filling system”shall not include automated devices usedsolely to count medication, vacuum tube drugdelivery systems governed by 20 CSR 2220-

2.800, or automated dispensing and storagesystems governed by 20 CSR 2220-2.900used to dispense medication directly to apatient or to an authorized health care practi-tioner for immediate distribution or adminis-tration to the patient;

(B) “Electronic verification system”—Anelectronic verification, bar code verification,weight verification, radio frequency identifi-cation (RFID), or similar electronic processor system that accurately verifies medicationhas been properly dispensed and labeled by,or loaded into, an automated filling system;

(C) “Manufacturer unit of use package”—A drug dispensed in the manufacturer’s orig-inal and sealed packaging, or in the originaland sealed packaging of a repackager, withoutadditional manipulation or preparation by thepharmacy, except for application of the phar-macy label;

(D) “Repackager”—A repackager registeredwith the United States Food and Drug Admin-istration; and

(E) “Repacked”—Any drug that has beenremoved from the original packaging of themanufacturer or a repackager’s packaging andis placed in a container for use in an automat-ed filling system.

(2) Medication Stocking. Automated fillingsystems (hereinafter “system”) may be stockedor loaded by a pharmacist or by an internpharmacist or pharmacy technician under thedirect supervision of a pharmacist. Pharmacyrepacked medication, cartridges, or containersshall comply with 20 CSR 2220-2.130.

(3) Verification. Except as provided herein, alicensed pharmacist shall inspect and verifythe accuracy of the final contents of any med-ication filled or packaged by an automatedfilling system, and any label affixed thereto,prior to dispensing, as required by 20 CSR2220-2.010(1)(B).

(4) The pharmacist verification requirementsof section (3) shall be deemed satisfied if—

(A) The pharmacy establishes and followsa policy and procedure manual that complieswith section (5) of this rule;

(B) The filling process is fully automatedfrom the time the filling process is initiateduntil a completed, labeled, and sealed pre-scription is produced by the automated fillingsystem that is ready for dispensing to thepatient. No manual intervention with themedication or prescription may occur afterthe medication is loaded into the automatedfilling system. For purposes of this section,manual intervention shall not include prepar-ing a finished prescription for mailing, deliv-ery, or storage;

(C) A pharmacist verifies the accuracy ofthe prescription information used by or

entered into the automatic filling system for aspecific patient prior to initiation of the auto-matic fill process. The name, initials, or iden-tification code(s) of the verifying pharmacistshall be recorded in the pharmacy’s recordsand maintained for five (5) years after dispens-ing;

(D) A pharmacist verifies the correct med-ication, repacked container, or manufacturerunit of use package was properly stocked,filled, and loaded in the automated filling sys-tem prior to initiating the fill process. Alterna-tively, an electronic verification system maybe used for verification of manufacturer unitof use packages or repacked medication pre-viously verified by a pharmacist;

(E) The medication to be dispensed isfilled, labeled, and sealed in the prescriptioncontainer by the automated filling system ordispensed by the system in a manufacturer’sunit of use package or a repacked pharmacycontainer;

(F) An electronic verification system isused to verify the proper prescription labelhas been affixed to the correct medication,repackaged container, or manufacturer unit ofuse package for the correct patient; and

(G) Daily random quality testing is con-ducted by a pharmacist on a sample size ofprescriptions filled by the automated fillingsystem. The required sample size shall notbe less than two percent (2%) of the prescrip-tions filled by the automated system on thedate tested or two percent (2%) of the pre-scriptions filled by the automated system onthe last day of system operation, as designat-ed in writing by the pharmacist-in-charge.Proof of compliance with this subsection andrandom quality testing date(s) and resultsshall be documented and maintained in thepharmacy’s records.

(5) Policies and Procedures. Pharmacies ver-ifying prescriptions pursuant to section (4) ofthis rule shall establish and follow writtenpolicies and procedures to ensure the proper,safe, and secure functioning of the system.Policies and procedures shall be reviewedannually by the pharmacist-in-charge andshall be maintained in the pharmacy’s recordsfor a minimum of two (2) years. The requiredannual review shall be documented in thepharmacy’s records and made available uponrequest. At a minimum, the pharmacy shallestablish and follow policies and proceduresfor—

(A) Maintaining the automated filling sys-tem and any accompanying electronic verifi-cation system in good working order;

(B) Ensuring accurate filling, loading, andstocking of the system;

(C) Ensuring sanitary operations of the


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system and preventing cross-contamination ofcells, cartridges, containers, cassettes, orpackages;

(D) Reporting, investigating, and address-ing filling errors and system malfunctions;

(E) Testing the accuracy of the automatedfilling system and any accompanying elec-tronic verification system. At a minimum, theautomated filling system and electronic veri-fication system shall be tested before the firstuse of the system or restarting the system andupon any modification to the automated fill-ing system or electronic verification systemthat changes or alters the filling or electronicverification process;

(F) Training persons authorized to access,stock, restock, or load the automated fillingsystem in equipment use and operations;

(G) Tracking and documenting prescriptionerrors related to the automated filling systemthat are not corrected prior to dispensing tothe patient. Such documentation shall bemaintained for two (2) years and produced tothe board upon request;

(H) Conducting routine and preventivemaintenance and, if applicable, calibration;

(I) Removing expired, adulterated, mis-branded, or recalled drugs;

(J) Preventing unauthorized access to thesystem, including, assigning, discontinuing,or changing security access;

(K) Identifying and recording personsresponsible for stocking, loading, and fillingthe system;

(L) Ensuring compliance with state andfederal law, including, all applicable labeling,storage, and security requirements; and

(M) Maintaining an ongoing quality assur-ance program that monitors performance ofthe automatic fill system and any electronicverification system to ensure proper andaccurate functioning.

(6) Recordkeeping. Except as otherwise pro-vided herein, records required by this ruleshall be maintained in the pharmacy’s recordselectronically or in writing for a minimum oftwo (2) years. When the verification require-ments of subsection (4)(D) of this rule arecompleted by a pharmacist, the name, initials,or identification code(s) of the verifying phar-macist shall be recorded in the pharmacy’srecords and maintained for five (5) years afterdispensing. Records shall be made availablefor inspection and produced to the board orthe board’s authorized designee upon request.

AUTHORITY: sections 338.250 and 338.280,RSMo 2000, and sections 338.140 and338.210.4, RSMo Supp. 2013.* Original rulefiled July 1, 2013, effective Jan. 30, 2014.

*Original authority: 338.140, RSMo 1939, amended1989, 1997, 2011; 338.210, RSMo 1951, amended 2001,2011; 338.250, RSMo 1951, amended 1990, 1998; and338.280, RSMo 1951, amended 1971, 1981.

