STATE OF WISCONSIN
PHARMACY EXAMINING BOARD
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IN THE MATTER OF RULEMAKING : PROPOSED ORDER OF THE
PROCEEDINGS BEFORE THE : PHARMACY EXAMINING BOARD
PHARMACY EXAMINING BOARD : ADOPTING RULES
: (CLEARINGHOUSE RULE )
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PROPOSED ORDER
An order of the Pharmacy Examining Board to create Phar 7.15, 10.03 (20), and 10.03 (21), relating to consumer disclosures.
Analysis prepared by the Department of Safety and Professional Services.
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ANALYSIS
Explanation of agency authority:
Section 15.08 (5) (b), Stats. states that “The Board shall promulgate rules for its own guidance and for the guidance of the trade or profession to which it pertains, and define and enforce professional conduct and unethical practices not inconsistent with the law relating to the particular trade or profession.” Section 450.02 (3) (a), Stats. allows the board to “promulgate rules relating to the manufacture of drugs and the distribution and dispensing of prescription drugs.” Section 450.02 (3) (d), Stats. says that the board “may promulgate rules necessary for the administration and enforcement of this chapter and ch. 961.” Section 450.02 (3) (e), Stats. provides that the board “may promulgate rules establishing minimum standards for the practice of pharmacy.” Plain language analysis: The objective of the proposed rule is to revise the Pharmacy administrative code, including but not necessarily limited to chs. Phar 7 and 10, to bring the code into compliance with current statutory provisions as modified by 2021 Wisconsin Act 9. The Pharmacy Examining Board is required under Act 9 to create and maintain a list of the 100 most commonly prescribed generic drug product equivalents, including the generic and brand name of the drug, which shall be made available to each pharmacy on an annual basis either directly or on the board’s website.
Act 9 created several new requirements for pharmacies as well. A pharmacy must make available to the public information on how to access the list of 100 most commonly prescribed generic drug product equivalents maintained by the Pharmacy Examining Board. Pharmacies also must make available to the public information on how to access the FDA’s list of all currently approved interchangeable biological products. Finally, a pharmacy must maintain disclosures to the public in a conspicuous place near where drugs are dispensed regarding the ability of a pharmacist to substitute a less expensive drug or interchangeable biological product.
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 2021Wisconsin 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, Dan Hereth, may be contacted by email at Jennifer.Garrett@wisconsin.gov, or by calling (608) 266-6795.
