STATE OF WISCONSIN PHARMACY EXAMINING BOARD
IN THE MATTER OF RULEMAKING : ORDER OF THE PROCEEDINGS BEFORE THE : PHARMACY EXAMINING BOARD PHARMACY EXAMINING BOARD : ADOPTING EMERGENCY RULES
The statement of scope for this rule, SS 052-22, was approved by the Governor on June 13, 2022, published in Register 798B on June 27, 2022, and approved by the Pharmacy Examining Board on July 8, 2022. This emergency rule was approved by the Governor on January 26, 2023. ORDER
An order of the Pharmacy Examining Board to amend Phar 1.01, 1.02 (intro), 1.02 (Note), 7.07 (2), 7.14 (2), (2) (b), (2) (c) 3. and 6., (2) (d) 1. and 2., (2) (e), (3) (a) and (b), (4) (a), (b), (c), and (d), (5), (6) (a) 1. and 2, 7.43 (7), ch. Phar 7 subch. V (title), 7.62 (title), (1), (2), (3) (intro.), (5), (6), and (7), 10.03 (2), (17), and (19); create Phar 1.01 (11m), 5.07, 7.60 (intro.) and (3), and ch. Phar 19; and repeal Phar 7.14 (2) and 7.62 (3) (a) to (d), relating to registration of pharmacy technicians. Analysis prepared by the Department of Safety and Professional Services.
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EXEMPTION FROM FINDING OF EMERGENCY
The Legislature by section 40 (1) of 2021 Wisconsin Act 100 provides an exemption from a finding of emergency for the adoption of the rule. (See PDF for image)
ANALYSIS
Statutes interpreted: s. 450.68, Stats. Wisconsin Action 100 s. 40 (1)
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.” 2021 Wisconsin Act 100, Section 40 (1) provides: “The pharmacy examining board may promulgate emergency rules under s. 227.24 necessary to implement this act. Notwithstanding s. 227.24 (1) (c) and (2), emergency rules promulgated under this subsection remain in effect until May 1, 2024, or the date on which permanent rules take effect, whichever is sooner.” Related statute or rule: s. 961.31, Stats. Plain language analysis: The objective of the proposed rule is to implement the statutory changes from 2021 Wisconsin Act 100. 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.
Comparison with rules in adjacent states:
Illinois: The Illinois Department of Financial and Professional Regulation is responsible for the licensure and regulation of Pharmacy in Illinois, with input from the Illinois Board of Pharmacy. The Illinois Pharmacy Practice Act contains requirements for licensure of registered pharmacy technicians, as well as for pharmacists and pharmacies. Registered pharmacy technicians in Illinois have to be at least 16 years old, is attending or has graduated from high school or has a high school equivalency certificate and must complete the requirements to become a licensed registered certified pharmacy technician. A licensed registered certified pharmacy technician must be at least 18 and as of January 1, 2024, have graduated from a pharmacy technician training program or obtained documentation from the pharmacist-in-charge at the pharmacy where they are employed that they have successfully completed a nationally accredited training program. [225 Illinois Complied Statutes ch. 85 s. 9 and 9.5]. The Illinois Department of Financial and Professional Regulation is also responsible for the promulgation of rules to implement certain sections of the Illinois Pharmacy Practice Act. These rules in the Illinois Administrative Code include application requirements for both registered and registered certified pharmacy technicians, as well as rules for their training and education [Illinois Administrative Code s. 1330.200-1330.220]. Iowa: The Iowa Board of Pharmacy is responsible for the licensure and regulation of Pharmacy practice in Iowa. Title IV Chapter 155A of the Iowa Code includes the statutory requirements for pharmacy technician registration, licensure of pharmacists and pharmacies, and prescription drug orders, among other requirements. In Iowa pharmacy technicians must register with the Iowa Board and the responsibility for their actions is with the licensed pharmacist who is supervising them [Iowa Code ch.155A s.6A]. The Iowa Pharmacy Practice Act rules are contained the Iowa Administrative Code and also include requirements for pharmacy technicians. Among those requirements, the chapter includes registration procedures, training, delegation and practice, national certification, as well as unethical conduct and discipline [657 Iowa Administrative Code ch. 3]. 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 pharmacy in Michigan, among several other occupations. Also included in those regulations are the statutory requirements for licensure and practice of pharmacy technicians. [Michigan Compiled Laws s. 333.17739]. The Michigan Administrative Rules also include requirements for pharmacy technicians administered by the Michigan Department of Licensing and Regulatory Affairs in conjunction with the Michigan Board. These rules include licensure, examination, training, and approved education program requirements for pharmacy technicians [Michigan Administrative Rules R 338.3561-338.3665]. Minnesota: The Minnesota Board of Pharmacy is responsible for the licensure and regulation of pharmacy practice in Minnesota. Part 6800 of the Minnesota Administrative Code includes the regulations for pharmacy in Minnesota. These rules include requirements for pharmacy technician registration, education, training, and supervision [Minnesota Administrative Rules part 6800.3850]. Chapter 151 of the Minnesota Statutes, or the Pharmacy Practice and Wholesale Distribution Act, also includes pharmacy regulations and requirements for pharmacy technicians. This statute specifically clarifies the nature of the supervisory relationship of the pharmacist to the technician, as well as how many technicians each individual pharmacist may supervise. [Minnesota Statutes 151.102]. Summary of factual data and analytical methodologies: The Board reviewed the statutory changes from 2021 Wisconsin Act 100 and updated Wisconsin Administrative Code Chapters Phar 1, 5, 7, 10 and 19 accordingly. Fiscal Estimate: The Fiscal Estimate will be attached upon completion.
Effect on small business:
These proposed 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.
