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 22-007)
------------------------------------------------------------------------------------------------------------
ORDER
An order of the Pharmacy Examining Board to amend Phar 15.30 (11), (13), and (17), 15.33 (10), and 15.37 (1) (intro.), (c), and (d); create Phar 15.30 (10m), (14g) and (14r), and 15.37 (5), (6), and (7); and repeal and recreate Phar 15.34, relating to compounding pharmaceuticals.
Analysis prepared by the Department of Safety and Professional Services.
------------------------------------------------------------------------------------------------------------
ANALYSIS
Explanation of agency authority:
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. [s. 15.08 (5) (b), Stats.] The board may promulgate rules necessary for the administration and enforcement of this chapter and ch. 961 and establish minimum standards for the practice of pharmacy. [s. 450.02 (3) (d) and (e), Stats.] Related statute or rule: N/A
Plain language analysis:
The objective of the rule is to review the updated United States Pharmacopeia (USP) 795 and 797 standards, which originally had a publication date of June 1, 2019 with an anticipated official date of December 1, 2019. However, due to appeals filed, the 2019 revisions of the USP are currently on hold. The 2008 USP 795 and 797 are the current standard for pharmacy compounding until those 2019 standards are published and effective.
Even though the Board will not be moving forward with the 2019 revisions at this time, there are still updates that need to be made to Phar 15 to align it with the 2008 USP 795 and 797 chapters that are currently in effect. It is the Board’s intent to amend Phar 15 without creating an unnecessary burden on Wisconsin pharmacies, while still aligning it with the current USP chapters. When new updated standards are available, the Board will consider opening a new scope statement to address any further changes if applicable.
Summary of, and comparison with, existing or proposed federal regulation:
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. For non-patient specific or “office use” of non-sterile compounded drugs, additional requirements apply. Among them, retrievable records must be maintained for at least 5 years and specific labelling requirements for office use. 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] Iowa: Iowa requires compliance with the current revisions of USP Chapters 795 and 797. In addition, an FDA registered outsourcing facility must be licensed as a pharmacy in Iowa. [Iowa Administrative Code ss. 657.20.3, 657.20.4, and 657.20.6] 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. 333.17748] 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:
The Pharmacy Examining Board primarily utilized United States Pharmacopeia chapters 795 and 797 which are the recognized pharmacopeia standards.
Analysis and supporting documents used to determine effect on small business or in preparation of economic impact report:
The proposed rules were posted for a period of 30 days to solicit public comment on economic impact, including how the proposed rules may affect businesses, local government units, and individuals. No economic impact comments were received.
Fiscal Estimate and Economic Impact Analysis:
