Plain language analysis: The objective of the proposed rule is to revise Wisconsin Administrative Code chs. Phar 7 and 10, to bring the code into compliance with current statutory provisions as modified by 2021 Wisconsin Act 9. Section Phar 7.15 was created to outline the new consumer disclosure requirements created in 2021 Wisconsin Act 9. Additional requirements were also added to Phar 10.03 regarding unprofessional conduct of a licensee. Summary of, and comparison with, existing or proposed federal regulation: Federal Regulations part: 21 CFR Subchapter D covers regulations for the FDA on Drugs for Human Use.
Comparison with rules in adjacent states:
Illinois: The Illinois Department of Financial and Professional Regulation (IDFPR) under the State Board of Pharmacy, regulates pharmacists. All consumer disclosures relating to prescription medication and pharmacy benefits management are regulated by the State Department of Insurance. Currently, the Illinois Board of Pharmacy is not responsible, nor regularly provides consumer disclosures regarding generic or prescription medication.
Iowa: Iowa pharmacists are regulated by the Board of Pharmacists. All consumer disclosures relating to prescription medication and pharmacy benefits management are regulated by the State Department of Insurance. Currently, the Iowa Board of Pharmacists is not responsible, nor regularly provides consumer disclosures regarding generic or prescription medication.
Michigan: The Michigan Department of Licensing and Regulatory Affairs (MDLRA) regulates pharmacists under the authority of the Michigan Board of Pharmacy. All consumer disclosures relating to prescription medication and pharmacy benefits management are regulated by the State Department of Insurance. Currently, the Michigan Board of Pharmacy is not responsible, nor regularly provides consumer disclosures regarding generic or prescription medication.
Minnesota: In Minnesota, pharmacists are regulated by the Minnesota Department of Health, with input from the Minnesota Board of Pharmacy. All consumer disclosures relating to prescription medication and pharmacy benefits management are regulated by the State Department of Insurance. Currently, the Minnesota Board of Pharmacy is not responsible, nor regularly provides consumer disclosures regarding generic or prescription medication.
Summary of factual data and analytical methodologies:
The proposed rules were developed by reviewing the current federal food and drug-approved interchangeable biological products; technical information provided by the American Pharmacists Association (APhA), and 2021 Wisconsin Act 9, relating to pharmacy benefit managers, prescription drug benefits, and granting rule-making authority. Analysis and supporting documents used to determine effect on small business or in preparation of economic impact analysis:
The rule was posted for 14 days on the Department of Safety and Professional Services website to solicit economic impact comments, including how the proposed rules may affect businesses, local municipalities, and private citizens. No comments were received.
Fiscal Estimate and Economic Impact Analysis:
The Fiscal Estimate and Economic Impact Analysis is attached.
Effect on small business:
These rules do not have an economic impact on small businesses, as defined in s. 227.114 (1), Stats. The Department’s Regulatory Review Coordinator may be contacted by email at Jennifer.Garrett@wisconsin.gov, or by calling (608) 266-2112. Agency contact person:
Nilajah Hardin, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, P.O. Box 8366, Madison, Wisconsin 53708-8366; telephone 608-267-7139; email at DSPSAdminRules@wisconsin.gov. ------------------------------------------------------------------------------------------------------------
TEXT OF RULE
Section 1. Phar 7.15 is created to read:
Phar 7.15 Consumer Disclosures.
(1) Each pharmacy shall post in a prominent place and maintain the consumer disclosures required in ss. 450.13 (5m) and 450.135 (8m), Stats. (2) A link to the 100 most commonly prescribed generic drug product equivalents as determined by the Board, shall be maintained on the Department website as required in s. 450.13 (5m) (b), Stats. Note: Copies of the required consumer disclosures are located on the Department of Safety and Professional Service’s website: https://dsps.wi.gov (3) Pursuant to s. 450.13 (5m) (c), Stats., each pharmacy shall maintain and make available to the public a list of the drugs from the list in sub. (2) that are available for purchase at that pharmacy. The list shall be updated monthly, with all of the following information included: (a) brand name.
(b) generic equivalent drugs and biological products.
(c) interchangeable biological products.
(d) retail price.
(4) The list required under sub. (3) may differ depending on whether the drugs on the list from sub. (2) are available for purchase at a specific pharmacy.
Section 2. Phar 10.03 (20) and (21) are created to read:
Phar 10.03 (20) Violating or attempting to violate any provision or term of ch. 450, Stats., or of any rule of the board. Phar 10.03 (21) Failure to comply with ss 450.13 (5m) or 450.135 (8m), Stats.
Section 3. EFFECTIVE DATE. the rules adopted in this order shall take effect on the first day of the month following publication in the Wisconsin Administrative Register, pursuant to s. 227.22 (2) (intro.), Stats. ------------------------------------------------------------------------------------------------------------
(END OF TEXT OF RULE)
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Dated _________________ Agency __________________________________
Chairperson
Pharmacy Examining Board
