compounding pharmacies | alabama · alabama 2015 al h 8 provides a specified state...

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COMPOUNDING PHARMACIES | Alabama State Enacted Bill Number Bill Summary Alabama 2015 AL H 8 Provides a specified state ''supplemental privilege tax'' (or provider tax) for each prescription filled or refilled, to be collected on the business activities of every provider of pharmaceutical services to the citizens of Alabama, except for a pharmacy serving hospital in-patients or pharmacies operated by the State of Alabama, for collection in fiscal years 2016 and 2017. The ''revenue generated from this tax will be eligible for Federal Medicaid matching funds (FMAP), being that portion of funds paid by the federal government to the State of Alabama for providing and administering the State's Medicaid Program. The tax would be void if it is not eligible for such matching funds. Alabama 2012 AL H 393 Relates to the practice of pharmacy and the operation of pharmacies; defines pharmacy services; authorizes the Alabama State Board of Pharmacy to provide by rule for the issuance, renewal, and fees relating to a pharmacy services permit; provides that the creation of a pharmacy services permit does not expand or limit the existing practice of pharmacy or medicine. Alabama 2012 AL S 383 Relates to audits of pharmacy records; establishes minimum and uniform standards and criteria for the audit of pharmacy records by or on behalf of certain entities; prescribes the procedures for conducting an audit; provides for an appeal process; provides that an entity conducting an audit may not use the accounting practice of extrapolation in calculating recoupments or penalties for audits. Alabama 2012 AL H 566 Relates to prescription drugs; allows a named federally qualified health care center and public health facility to compound and dispense non-controlled substances at one location and deliver the medications to clinics for patient pick-up.

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COMPOUNDING PHARMACIES | Alabama

State Enacted Bill Number Bill Summary Alabama 2015 AL H 8 Provides a specified state ''supplemental privilege tax'' (or provider tax) for each prescription filled or refilled, to be

collected on the business activities of every provider of pharmaceutical services to the citizens of Alabama, except for a pharmacy serving hospital in-patients or pharmacies operated by the State of Alabama, for collection in fiscal years 2016 and 2017. The ''revenue generated from this tax will be eligible for Federal Medicaid matching funds (FMAP), being that portion of funds paid by the federal government to the State of Alabama for providing and administering the State's Medicaid Program. The tax would be void if it is not eligible for such matching funds.

Alabama 2012 AL H 393 Relates to the practice of pharmacy and the operation of pharmacies; defines pharmacy services; authorizes the Alabama State Board of Pharmacy to provide by rule for the issuance, renewal, and fees relating to a pharmacy services permit; provides that the creation of a pharmacy services permit does not expand or limit the existing practice of pharmacy or medicine.

Alabama 2012 AL S 383 Relates to audits of pharmacy records; establishes minimum and uniform standards and criteria for the audit of pharmacy records by or on behalf of certain entities; prescribes the procedures for conducting an audit; provides for an appeal process; provides that an entity conducting an audit may not use the accounting practice of extrapolation in calculating recoupments or penalties for audits.

Alabama 2012 AL H 566 Relates to prescription drugs; allows a named federally qualified health care center and public health facility to compound and dispense non-controlled substances at one location and deliver the medications to clinics for patient pick-up.

COMPOUNDING PHARMACIES | California

State Enacted Bill Number Bill Summary California 2015 CA A 486 Requires that certain information be displayed on a human-readable unit-dose label, and that information to be

retrievable by a pharmacist using the medication lot number or control number. Requires a medication barcode to be machine readable, using medication administration software, and that the software compare certain information to the electronic medical record of an inpatient in order to verify that the medication to be given is the correct medication, dosage, and route of administration.

California 2013 CA S 294 Prohibits a pharmacy from compounding or dispensing, and a nonresident pharmacy from compounding for shipment into this state, sterile drug products for injection, administration into the eye, or inhalation, unless the pharmacy has obtained a sterile compounding pharmacy license from the Board of Pharmacy. Specifies requirements for the issuance or renewal of a license, and requirements for the pharmacy as a licensee.

COMPOUNDING PHARMACIES | Colorado

State Enacted Bill Number Bill Summary Colorado 2016 CO H 1152 Authorizes the Department of Corrections to distribute compounded and prepackaged medications to pharmacies

under the same ownership as the department.

Colorado 2012 CO H 1311 Relates to the continuation of the State Board of Pharmacy, the rehabilitation evaluation committee and transfers its duties to the state board, license fee increase to cover the costs of the Pharmacy Peer Health Assistance Program, hospital satellite pharmacies, veterinary prescription drug wholesalers, board letters of admonition, pharmacist managers, interns, and prescription requirements.

COMPOUNDING PHARMACIES | Florida

State Enacted Bill Number Bill Summary Florida 2016 FL H 423 Relates to access to health care services, relates to a state employees' prescription drug program, deputy and state

pilot certification, certain licensure requirements and grounds for discipline, penalties and enforcement, controlled substances and certain authorizations relating to prescription drugs, practice standards, physician responsibilities relating to pain management clinics, physician assistants, prior authorization, and formal supervisory relationships and protocols for certain physicians.

Florida 2016 FL H 977 Relates to the behavioral health workforce to include prescribing name brand drugs, advanced registered nurse practitioner or a physician assistant, patient admission to a treatment facility, pain-management clinic prescribing, the Board of Nursing, controlled substances formulary, continued education, disciplinary action, nonresident sterile compounding permits, volunteer nurses, anesthesiologist assistants, disability parking endorsement, and community control conditions.

COMPOUNDING PHARMACIES | Georgia

State Enacted Bill Number Bill Summary Georgia 2016 GA H 926 Relates to pharmacists and pharmacies, provides for licensure of third-party logistics providers, provides for temporary

pharmacy licenses for service members, requires that compounding of drug products for use in a practitioner's office can only be conducted by outsourcing facilities to conform to federal law, provides for drug supply chain security, relates to the return of outdated drugs, provides wholesale distributors, warehousing, chain pharmacies, reverse drug distributors and out-of-state firms.

Georgia 2013 GA H 209 Relates to pharmacists and pharmacies, provides for license transfers for pharmacists licensed in another jurisdiction, relates to dispensing prescription drugs, use of security paper for hard copy prescription drug orders, compounding drug products, nonresident pharmacy permits and the electronic data base of prescription information, revises the definition of a dispenser relative to information to include for each Schedule II, III, IV, or V controlled substance prescription.

COMPOUNDING PHARMACIES | Idaho

State Enacted Bill Number Bill Summary Idaho 2015 ID H 8 Relating to pharmacists, prohibits wholesale distribution of drugs or devices by pharmacies, with certain exceptions,

provides that certain persons may possess legend drugs, provides that pharmacists must keep patient records, revises and clarifies licensure requirements, requires that wholesale distributors monitor and identify certain drug orders, removes language relating to returns or exchanges of prescription drugs.

COMPOUNDING PHARMACIES | Indiana

State Enacted Bill Number Bill Summary Indiana 2012 IN H 1280 Relates to regulatory matters; provides that intrastate commerce is not subject to the authority of the United States

Congress; provides a review of agency rules; imposes a duty on a state agency to give a person an opportunity to correct a violation discovered in an inspection; requires hearing officers and administrative law judges to be licensed attorneys; provides for carrier regulation, in-state products, public hearings, franchise fees and mail order pharmacy permits.

COMPOUNDING PHARMACIES | Kansas

State Enacted Bill Number Bill Summary Kansas 2011 KS H 2182 Amends health care provisions; includes pharmacy audit procedures, pharmacy benefit managers, resident's right to

purchase or refuse to purchase health insurance; provides for acceptance of unused medications, health provider licensure and regulation, physical therapists, addiction counseling, electronic health records and confidentiality, health care representatives, school sports head injury prevention, EMS, dentists, nurses and smoking laws.

Kansas 2011 KS S 397 Relates to terminology change from mental retardation and similar terms to intellectual disability and similar terms.

Kansas 2011 KS S 134 Creates the licensure role of advanced practice registered nurse; relates to renewal of licenses; provides grounds for disciplinary action for violations; relates to felony convictions; relates to evidence of completion of continuing education; amends provisions regarding prescribing of drugs.

Kansas 2011 KS S 211 Concerns pharmacists; relates to dispensing prescriptions; provides that a pharmacist may provide up to three-month supply of a prescription drug that is not a controlled substance or psychotherapeutic drug when a practitioner has written a drug order to be filled with a smaller supply but included sufficient numbers of refills for a three-month supply.

Kansas 2012 KS H 2792 Reconciles amendments to certain statutes and makes certain technical changes related thereto, including statutes relating to ad valorem taxes, payroll withholding taxes, unemployment contribution taxes, insurance agents or insurance solicitor, health insurers and health maintenance organizations, and tax information of firms contracting with the Secretary of Revenue.

COMPOUNDING PHARMACIES | Kentucky

State Enacted Bill Number Bill Summary Kentucky 2012 KY S 3 Relates to drugs; includes drugs containing non-liquid ephedrine, pseudoephedrine, or phenylpropanolamine within

the definition of a legend drug; limits the amount of ephedrine-based, pseudoephedrine-based, or phenylpropanolamine-based legend drugs available without a prescription to 15 grams per year and 3.6 grams per month; requires the use of the electronic sales logging system, to require the system to block sales to certain purchasers, and to require annual statistical reporting.

COMPOUNDING PHARMACIES | Maryland

State Enacted Bill Number Bill Summary Maryland 2015 MD S 69 Repeals the requirement that certain entities hold a sterile compounding permit and the requirement that a person

that prepares and distributes sterile drug products into or within the State hold a certain permit, repeals requirements for inspections of and reporting by sterile compounding permit holders, repeals a requirement that an inspection report submitted by a wholesale distributor demonstrate certain compliance, requires certain nonresident pharmacies to obtain an inspection report.

Maryland 2013 MD H 986 Requires a sterile compounding facility to hold a sterile compounding permit issued by the State Board of Pharmacy before the sterile compounding facility may perform sterile compounding in the State, provides that a sterile compounding permit is required in addition to and does not replace other permits or licenses, provides that a person that prepares and distributes sterile drug products into or within the State is not required to hold a sterile compounding permit but shall hold certain other permits.

COMPOUNDING PHARMACIES | Michigan

State Enacted Bill Number Bill Summary Michigan 2015 MI S 468 Modifies eligibility for licensure of pharmacy technicians and requirements for limited license pharmacy technicians,

relates to multiple licensed pharmacy locations, compounding services for sterile pharmaceuticals, and maintenance of pharmacy records.

Michigan 2012 MI S 1082 Classifies synthetic cannabinoids as schedule 1 controlled substances; prohibits selling and offer to sell certain products represented to contain controlled substances or having the effects of controlled substances.

COMPOUNDING PHARMACIES | Minnesota

State Enacted Bill Number Bill Summary Minnesota 2013 MN H 1233 Redefining research drugs, by adding: (3) dispensing and distribution of research drugs by pharmacies shall not be

considered compounding, manufacturing, or wholesaling under this chapter.

Minnesota 2012 MN H 1236 Establishes a program for the audit of pharmacy records carried out by a pharmacy benefits manager or a representing entity; prohibits a pharmacy benefits manager from requiring that certain information be written on a prescription; provides that recoupment may be assessed for certain information not written on a prescription, including information relating to a drug manufacturer's product safety program; requires copies of claims included in an audit to be provided to a plan sponsor.

Minnesota 2012 MN S 1675 Relates to human services; modifies provisions related to children and family services; reforms adoptions under guardianship of the commissioner; modifies statutory provisions related to child support; relates to employer payroll taxes and unemployment taxes, employee health and disability insurance, liability insurance, and workers' compensation insurance.

Minnesota 2012 MN H 2508 Relates to public safety; aligns state-controlled substance schedules with federal controlled substance schedules; modifies authority of the Board of Pharmacy to regulate controlled substances; provides for penalties.

Minnesota 2012 MN H 2532 Relates to health; allows prescriptions for controlled substances to be transmitted electronically or by facsimile if the prescription meets State law and federal regulations.

Minnesota 2012 MN S 2493 Relates to natural resources; appropriates money from the outdoor heritage fund; modifies requirements for outdoor heritage fund appropriations; appropriates money for clean water; appropriates money for an Aquatic Invasive Species Cooperative Research Center; modifies prior appropriations; modifies specified parks and trails grant program provisions.

COMPOUNDING PHARMACIES | Nebraska

State Enacted Bill Number Bill Summary Nebraska 2015 NE L 37 Would create the Prescription Drug Safety Act, changes and transfers pharmacy, prescription, and drug provisions.

Would provide that ""Compounding in a hospital pharmacy may occur for any hospital which is part of the same health care system under common ownership or which is a member of or an affiliated member of a formal network or partnership agreement.""

Nebraska 2011 NE L 179 Changes pharmacy provisions; changes prescribing provisions under the Uniform Controlled Substance Act; defines the term samples to mean a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug; provides that to be eligible to take the pharmacist licensure examination, every applicant must present proof of graduation from an accredited pharmacy program.

COMPOUNDING PHARMACIES | New Hampshire

State Enacted Bill Number Bill Summary New Hampshire 2015 NH S 202 Establishes the requirement for licensure by the Pharmacy Board of outsourcing facilities operating pursuant of the

federal Food, Drug, and Cosmetic Act, relates to licensure of outsourcing facilities by the Board, requires federal guidelines to be finalized and adopted, relates to maintaining regulatory consistency for outsourcing facilities with the federal government, requires that no license shall be issued unless the applicant has furnished proof satisfactory to the Board.

New Hampshire 2013 NH H313 Provides for regulation of the compounding of drugs by pharmacists; provides that a licensed pharmacist shall have the right to conduct a pharmacy for the compounding of medicines upon physicians', dentists' and physician assistants' prescriptions or a valid order for the sale, and distribution of drugs; requires that the compound drug product bear the label of the pharmacy responsible for compounding and dispensing the product directly to the patient for administration.

COMPOUNDING PHARMACIES | New Jersey

State Enacted Bill Number Bill Summary New Jersey 2012 NJ A 3104 Reorganizes and renames Department of Health and Senior Services as Department of Health; establishes Division of

Aging Services in Department of Human Services; transfers certain services and programs for senior citizens from the Department of Health and Senior Services to the new Division of Aging Services; revises various parts of the statutory law to include the provisions governing the Medical Malpractice Insurance Premium Assistance Fund.

COMPOUNDING PHARMACIES | North Dakota

State Enacted Bill Number Bill Summary North Dakota 2015 ND S 2086 Relates to drugs provided by outsourcing facilities and third-party logistics providers, relates to wholesale drug

distribution and third-party logistic providers, relates to outsourcing facilities engaged in anticipatory compounding of sterile drugs, relates to repackagers, provides for reciprocity of retail durable medical equipment retailers, provide for rental items through Medicare and Medicaid services.

COMPOUNDING PHARMACIES | Ohio

State Enacted Bill Number Bill Summary Ohio 2011 OH H 86 Relates to Medicaid and workers' compensation fraud, trafficking in controlled substances, child-victim offenders,

violent offender escape, parole hearings, prisoner credits, post-release GPS monitoring, pretrail and postconviction confinement, inmate reentry plan, a offender risk assessment tool, community control sanctions, juvenile probation grants, delinquent youth task force, truancy, inmate assault, speeding violations, older inmate parole, shoplifting, identity fraud, and crime victims.

Ohio 2012 OH H 487 Makes operating and other appropriations; provides authorization and conditions for the operation of state programs; relates to the levying of a tax by school districts; relates to the taxation of independent living facilities; relates to regional transit authority taxation; relates to special district taxation; relates to the liability insurance of motor carriers; relates to gross premium taxation; relates to liability insurance for fireworks manufacturers; relates to workers' compensation insurance.

COMPOUNDING PHARMACIES | Oklahoma

State Enacted Bill Number Bill Summary

Oklahoma 2016 OK S 1150 Restricts and requires licensing of outsourcing pharmacies or warehouses. Oklahoma 2011 OK S 919 Relates to the Uniform Controlled Dangerous Substances Act; designates certain substances as Schedule I through

Schedule V substances; authorizes an electronic prescription method; clarifies the weight amounts for certain substances; modifies the agency responsible for the destruction of seized or surrendered property; requires the registration with the State Dangerous Drugs Control Registry of persons convicted in other jurisdictions; modifies the registration time limitation.

Oklahoma 2011 OK S 878 Provides for a mass revision of the Workers' Compensation Code.

Oklahoma 2012 OK H 292 Relates to public health and safety; relates to the Uniform Controlled Dangerous Substances Act; adds certain substances to certain schedules; relates to prescriptions; authorizing use of electronic prescribing methods; relates to the Anti-Drug Diversion Act; deletes exception to transmission requirement for nonresident drug outlets; amends provision relating to drug cleanup fines; makes the imposition of cleanup fines discretionary.

Oklahoma 2012 OK H 2941 Requires electronic pharmacy records of nonprescription pseudoephedrine or ephedrine sales; directs pharmacies to electronically submit information prior to completing certain sales; provides an exception; makes pharmacies exempt from civil liability under certain circumstances; provides for the confidentiality of information collected; provides exemptions; provides for purchase restrictions; provides for stop-sale alerts and the methamphetamine offender registry; allows a service charge for such products.

COMPOUNDING PHARMACIES | Rhode Island

State Enacted Bill Number Bill Summary Rhode Island 2015 RI H 5497 Would authorize pharmacists to perform limited function clinical laboratory tests, providing that ""Compounding shall

only occur in the pharmacy where the drug or device is dispensed to the patient or caregiver and includes the preparation of drugs or devices in anticipation of prescription orders based upon routine, regularly observed prescribing patterns.""

Rhode Island 2011 RI H 5211 Allows the administration of immunizations by a pharmacy to adults and children nine years of age and older; require a pharmacist who is authorized to administer immunizations to electronically report to the Department of Health all immunizations administered within fourteen days of administration in the format and for the populations required by the department; takes effect upon passage.

Rhode Island 2011 RI S 480 Allows the administration of influenza immunizations by a pharmacy to adults and children 9-18 years of age pursuant to a valid prescription and necessary training requirements; requires parental consent for immunizations for children under 18; requires a pharmacist who is authorized to administer immunizations to electronically report to the department of health all immunizations administered within 7 days of administration in the format and for the populations required by the department.

COMPOUNDING PHARMACIES | Tennessee

State Enacted Bill Number Bill Summary Tennessee 2013 TN S 582 Relates to Pharmacy, revises the definition of compounding to include the preparation, mixing, assembling, packaging

or labeling of a drug or device for use in a practitioner's office, medical facility, by emergency medical services or a licensed veterinarian for administration to the prescribing practitioner's patients when the product is not commercially available, provides for licensure and inspection of out of state pharmacies, exempts hospital compounding pharmacies from specified reporting.

COMPOUNDING PHARMACIES | Texas

State Enacted Bill Number Bill Summary Texas 2013 TX S 1100 Relates to the licensing and inspection of out-of-state pharmacies by the Texas State Board of Pharmacy, authorizes

fees.

COMPOUNDING PHARMACIES | Utah

State Enacted Bill Number Bill Summary Utah 2013 UT H 200 (d) follows USP-NF 797 standards for sterile compounding if the drug dispensed to patients is reconstituted or

compounded. Modifies parts of the Utah Code to make technical corrections, including eliminating references to repealed provisions, making minor wording changes, updating cross references, and correcting numbering, modifies parts of the Utah Code to make technical corrections, including eliminating references to repealed provisions, making minor wording changes, updating cross references, correcting numbering, and fixing errors that were created from the previous year's session.

Utah 2013 UT S 14 Pharmacy Practice Act. Amends the Pharmacy Practice Act, defines research using pharmaceuticals, exempts research using pharmaceuticals from licensure to engage in the practice of pharmacy, telepharmacy, or the practice of a pharmacy technician, exempts research using pharmaceuticals from licensure to act as a pharmacy, makes technical corrections.

Utah 2012 UT H 254 Modifies the Controlled Substances Act; amends the definition of a controlled substance to allow proof that the substance is chemically substantially similar to a controlled substance, without requiring proof of the effect of the substance by the expert testimony of a pharmacologist; adds benzylpiperazine to Schedule I of the controlled substances list; adds AM-2201, RCS-4, JWH-210, and JWH-203 to the list of listed controlled substances.

Utah 2012 UT H 434 Amends the Pharmacy Practice Act; amends the definition of a pharmacy preceptor; amends provisions relating to a prescribing practitioner providing sample drugs to a patient.

Utah 2012 UT H 76 Requires health benefit plans, the Public Employees' Benefits and Insurance Program, and pharmacy benefit managers to implement certain pharmacy audit procedures when auditing pharmacy claims; requires a health insurer and a pharmacy benefits manager for a health insurer to comply with pharmacy audit rights established in the Pharmacy Practice Act; requires the Public Employees' Benefit and Insurance Program to comply with pharmacy audit rights established in the Pharmacy Practice Act.

COMPOUNDING PHARMACIES | Virginia

State Enacted Bill Number Bill Summary Virginia 2015 VA H 1737 Relates to outsourcing facilities and nonresident outsourcing facilities and compounding for office-based

administration, creates a new regulatory framework for permitting of outsourcing facilities that compound drugs and are located within Virginia and registering nonresident outsourcing facilities in Virginia.

Virginia 2014 VA H 5002 Funds the University School of Pharmacy to support the Center for Compounding Practice and Research. The allocation will serve to support any costs associated with creating the Center including facility-related expenses as well as the purchase of the compounding equipment necessary for this state of the art teaching. The Center will train Pharm. D. students to meet technical compounding demands, provide continuing education to registered pharmacists and conduct ongoing research on compounded medications.

Virginia 2012 VA H 2312 Relates to compounding pharmacies, clarifies the definition of compounding and adds a requirement for a current inspection report for registration or renewal of a registration for a nonresident pharmacy, provides that the compounding of an inordinate amount of a preparation where there is not historical pattern of prescriptions to support an expectation of receiving a valid prescription for the preparation shall constitute manufacturing of drugs.

Virginia 2012 VA H 733 Relates to pharmacists; relates to compounding authority; increases pharmacists' authority to compound to allow the compounding of a commercially manufactured drug whose manufacturer has notified the FDA that the drug is unavailable due to a current drug shortage, or a commercially manufactured drug when the prescriber has indicated in the prescription for an individual patient that there is an emergent need for a drug that is not readily available within the medically necessary time.

Virginia 2012 VA S 294 Relates to methamphetamine precursors; relates to pharmacies, sale and tracking; relates to penalties; requires the Department of State Police to enter into a memorandum of understanding to establish the Commonwealth's participation in a real-time electronic recordkeeping and monitoring system for the nonprescription sale of ephedrine or related compounds; provides a penalty for failure to report sales.

Virginia 2012 VA H 346 Amends provisions governing the practice of nurse practitioners; provides that nurse practitioners shall only practice as part of a patient care team, which shall include at least one licensed patient care team physician; relates to persons licensed to practice osteopathy when taking blood or giving injections; relates to fitting artificial limbs; requires professional liability insurance; relates to prescribing controlled substances.

Virginia 2012 VA H 1301 Relates to budget Bill; provides that appropriations of the Budget providing a portion of revenues for the two years ending respectively on the thirtieth day of June, 2013, and the thirtieth day of June, 2014; relates to a study of restructuring the local Business, Professional, and Occupational License Tax; authorizes an annual food-related inspection fee; relates to third party coverage under a medical support order; requires the modernization of the unemployment insurance benefits and tax system.

COMPOUNDING PHARMACIES | Washington

State Enacted Bill Number Bill Summary Washington 2012 WA H 1486 Authorizes Washington pharmacies to fill prescriptions written by advanced registered nurse practitioners in other

states.

Washington 2012 WA H 2056 Changes the term boarding home to assisted living facility throughout the boarding home licensing statute and elsewhere in the state Revised Code; provides that the Department of Social and Health Services is authorized to apply rules regarding boarding homes to assisted living facilities.

COMPOUNDING PHARMACIES | West Virginia

State Enacted Bill Number Bill Summary West Virginia 2012 WV S 437 Relates generally to substance abuse; relates to opioid treatment programs and facilities, education and training

requirements for treatment facility staff, licensing and oversight of chronic pain management clinics, end-of-life care education, health professional drug diversion training, the compounding and dispensing of prescriptions, a controlled substances monitoring program, methamphetamine laboratories and restrictions on the sale of ephedrine, pseudoephedrine and precursors, and related matters.