STATE OF WISCONSIN
PHARMACY EXAMINING BOARD
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IN THE MATTER OF RULEMAKING : ORDER OF THE
PROCEEDINGS BEFORE THE : PHARMACY EXAMINING BOARD
PHARMACY EXAMINING BOARD : ADOPTING RULES
: (CLEARINGHOUSE RULE 23-031)
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ORDER
An order of the Pharmacy Examining Board to create Phar 18, relating to licensure of third-party logistics providers.
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. Authorizes 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. provides that the board “may promulgate rules necessary for the administration and enforcement of this chapter and Ch. 961.” Section 450.075 (4), Stats. says: “The board shall promulgate rules implementing this section. The rules shall ensure compliance with the federal drug supply chain security act, 21 USC 360eee, et seq. The board may not promulgate rules that impose requirements more strict than the federal drug supply chain security act or any regulations passed under the federal drug supply chain security act. The board may not promulgate rules that require a license under this section.” Related statute or rule: Wisconsin Administrative Code Chapter Phar 18
Plain language analysis: The object of the proposed rule is to implement the statutory changes from 2021 Wisconsin Act 25. This was accomplished by creating chapter Phar 18, entitled Third-Party Logistics providers, a new chapter in the Wisconsin Administrative Code that outlines requirements for a new optional state license. Summary of, and comparison with, existing or proposed federal regulation: 21 U.S. Code s. 360eee includes national standards for third-party logistics providers. These standards include guidelines for a federal licensure program issued by the Secretary of the U.S. Department of Health and Human Services. This section also includes clarifications for those states that have a licensure program. Third-party logistics providers must either be licensed at the state level, if such a licensure program exists, or federally. On February 4, 2022, the U.S. Food and Drug Administration announced a proposed rule in National Standards for Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers. This rule has not been finalized yet.
Comparison with rules in adjacent states:
Illinois: The Illinois Department of Financial and Professional Regulation is responsible for the licensure and regulation of wholesale distribution in Illinois, with input from the Illinois Board of Pharmacy. The Illinois Wholesale Distribution Act contains requirements for licensure of resident and non-resident third-party logistics providers. In addition to obtaining licensure, each third-party logistics provider must also submit the information of a designated representative responsible for operations at each site [225 Illinois Complied Statutes ch. 120 s. 25.5]. Iowa: The Iowa Board of Pharmacy is responsible for the licensure and regulation of Pharmacy practice in Iowa. The Iowa Pharmacy Practice Act rules are contained in the Iowa Administrative Code and include requirements for licensure of third-party logistics providers. In addition to obtaining licensure, each third-party logistics provider must also submit the information of a facility manager responsible for operations at each site [657 Iowa Administrative Code ch. 43]. Michigan: The Michigan Board of Pharmacy is responsible for the licensure and regulation of pharmacy practice in Michigan. Act 368 Article 15 Part 177 of the Michigan Compiled Laws includes the regulations for wholesale distribution in Michigan, among several other occupations. Wholesale distributor-brokers serve the same function as third-party logistics providers. In Michigan, wholesale distributor-brokers are required to be licensed and must designate a facility manager or pharmacist-in-charge to be responsible for each site [Michigan Compiled Laws s. 333.17748].
Minnesota: The Minnesota Board of Pharmacy is responsible for the licensure and regulation of pharmacy practice and wholesale distribution in Minnesota. Chapter 151 of the Minnesota Statutes, or the Pharmacy Practice and Wholesale Distribution Act, also includes licensure requirements for third-party logistics providers. In Minnesota, the facility manager or designated representative responsible for each third-party logistic provider license cannot have any felony convictions relating to wholesale distribution and must be fingerprinted as authorized by the Minnesota Board. [Minnesota Statutes s. 151.471]. Summary of factual data and analytical methodologies:
The Board reviewed the statutory changes from 2021 Wisconsin Act 25 and added to the Wisconsin Administrative Code accordingly. 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. ------------------------------------------------------------------------------------------------------------
