STATE OF WISCONSIN
PHARMACY EXAMINING BOARD
IN THE MATTER OF RULEMAKING : PROPOSED ORDER OF THE
PROCEEDINGS BEFORE THE : PHARMACY EXAMINING BOARD
PHARMACY EXAMINING BOARD : ADOPTING RULES
: (CLEARINGHOUSE RULE )
PROPOSED ORDER
An order of the Pharmacy Examining Board to repeal and recreate chapter Phar 15, relating to Compounding Pharmaceuticals.
Analysis prepared by the Department of Safety and Professional Services.
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) (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.” Related statute or rule: N/A
Plain language analysis:
The Pharmacy Examining Board recently completed a revision to Wisconsin Administrative Code Chapter Phar 15 which became effective on August 1, 2022. The objective of this rule is to repeal and recreate the recent version of Phar 15 to incorporate by reference United States Pharmacopeia (USP) General Chapters 795 and 797, published on November 1, 2022. The Board will also be incorporating USP General Chapter 800, published on December 1, 2019, as well as USP General Chapter 825, published on December 1, 2020.
Summary of, and comparison with, existing or proposed federal regulation:
The practice of pharmacy is not regulated by the federal government and Wisconsin has its own controlled substances schedules. However, the federal government does regulate federally controlled substances and the vast majority of Wisconsin controlled substances are also federally controlled substances. Title 21 CFR Chapter II governs federally scheduled controlled substances, including: registration of manufacturers, distributors and dispensers of controlled substances; prescriptions; orders for schedule I and II controlled substances; requirements for electronic orders and prescriptions; and disposal.The states are primarily responsible for the oversight of compounding in pharmacies. Pursuant to the Drug Quality and Security Act, the federal government is responsible for outsourcing facilities, which by definition are not pharmacies, and are subject to current good manufacturing practice requirements, labeling requirements and may distribute compounded drugs in response to an order that is not patient specific. The Food, Drug and Cosmetic Act requires drugs to be prepared, packed or held under sanitary conditions.
Summary of public comments received on statement of scope and a description of how and to what extent those comments and feedback were taken into account in drafting the proposed rule: N/A
Comparison with rules in adjacent states:
Illinois: For patient-specific prescriptions, sterile and unsterile pharmaceutical compounding is governed by the USP 42-NF 37 from the 2019 USP Compounding Compendium, except for USP Chapter 800. Additionally, all pharmacies that compound drugs must maintain a set of minimum standards and equipment. These requirements include a specific area for compounding materials, accurate scales or measuring equipment, a separate area for compounding, a record keeping system for tracking compounded drugs, drug distribution procedures, and labelling. Additional requirements for sterile compounding include current reference materials, pharmacist availability at all times to answer patient and health care professional questions, and emergency medications for adverse drug reactions to compounded sterile drugs. [Illinois Administrative Code s. 1330.640]. In Illinois, the definition of “compounding” excludes flavorings [225 Illinois Compiled Statutes 85 s. 3 (o)]. Iowa: Iowa requires compliance with the current revisions of USP Chapters 795 and 797. Additionally, Iowa includes requirements for the use of flavoring agents. These requirements include that pharmacist may add flavoring in the amount of not more than percent of the total volume of the drug. The beyond-use date of the flavored drug must be no greater than 14 days and the pharmacist must document that a flavoring agent was added to a drug. Compliance with USP Chapter 825 is not required, however Iowa does have its own rules for radiopharmaceuticals and nuclear pharmacy [Iowa Administrative Code ss.657.16 and 657.20].
Michigan: Michigan requires a pharmacy that provides compounding services to be licensed as a pharmacy and authorized to provide compounding services. The pharmacy must be accredited through a national accrediting organization and be in compliance with USP standards [Michigan Compiled Laws s. 333.17748a to c]. In Michigan, the definition of “compounding” does not include flavoring agents that are nonallergenic, inert, and not more than 5% of the drug’s total volume [Michigan Administrative Rules R 338.501 (1) (e)]. Minnesota: Minnesota requires pharmacies compounding nonsterile drug preparations to follow USP chapter 795 standards. Pharmacies compounding sterile drug preparations are required to follow USP chapter 797 standards. [Minnesota Administrative Rules s.6800.3300]
Summary of factual data and analytical methodologies: In addition to the four adjacent states listed above, the Pharmacy Examining Board also reviewed statutes and regulations regarding compounding pharmaceuticals from other states including Arizona, California, Colorado, Connecticut, Idaho, Kentucky, Louisiana, Massachusetts, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, North Carolina, Ohio, Pennsylvania, South Carolina, South Dakota, Texas, Utah, West Virginia, and Wyoming.
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) 266-6795. Agency contact person:
