CR 23-072 Rule Text

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.

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: 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 must be at least 16 years old, currently attending or have graduated from high school or have a high school equivalency certificate and have completed the requirements to become a licensed registered certified pharmacy technician. A 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 in the Iowa Administrative Code and 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 338.3651-338.3665].

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 or created Wisconsin Administrative Code Chapters Phar 1, 5, 7, 10 and 19 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 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 [e-mail], or by calling [phone].

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 [phone]; email at [e-mail].

Place where comments are to be submitted and deadline for submission:

Comments may be submitted to Nilajah Hardin, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, P.O. Box 8366, Madison, Wisconsin 53708-8366, or by email to [e-mail]. Comments must be received on or before the public hearing, held on January 18, 2024, to be included in the record of rule-making proceedings.

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TEXT OF RULE

SECTION 1. Phar 1.01, 1.02 (intro.), and 1.02 (Note) are amended to read:

Phar 1.01 Authority. Rules in chs. Phar 1 to 1719 are adopted under authority of ss.

15.08 (5) (b), 227.11 (2), Stats, and ch. 450, Stats.

Phar 1.02 (intro.) As used in ch. Par 1 to 1719.

Phar 1.02 (Note) The board office is located at 1400 East Washington Avenue 4822 Madison Yards Way Madison, WI 5370253705.

SECTION 2. Phar 1.01 (11m) is created to read:

Phar 1.01 (11m) “Pharmacy technician” means a person registered by the board under s. 450.068, Stats.

SECTION 3. Phar 5.07 is created to read:

Phar 5.07 Pharmacy Technicians. (1) All requirements for renewal and reinstatement of a pharmacy technician registration are specified in chapter Phar 19.

(2) No pharmacist whose license has been denied, revoked, suspended, or restricted for disciplinary purposes is eligible to be registered as a pharmacy technician.

SECTION 4. Phar 7.07 (2); 7.14 (title); 7.14 (1) (a), (b) and (d); and 7.14 (2) are amended to read:

Phar 7.07 (2) For all prescription drug product products or device dispensing devices dispensed by a pharmacist, the prescription record shall identify the pharmacist responsible for each part of the final check. If sub. (1) (a) or (b) is completed by delegate-check-delegate a pharmacy product verification technician under s. Phar 7.14 or automated technology under s. Phar 7.55, the prescription record shall identify the delegate pharmacy product verification technician performing the check.

Phar 7.14 (title) Delegate-check-Delegate Pharmacy Product Verification Technician-check-Pharmacy Technician.

Phar 7.14 (1) (a) “Delegate Pharmacy product verification technician” means a person registered pharmacy technician to whom the pharmacist has delegated the task of product verification.

Phar 7.14 (1) (b) “Delegate-check-delegate Pharmacy product verification technician-check- pharmacy technician” means the process in which one delegate a pharmacy product verification technician conducts the task of product verification of technical dispensing functions completed by an unlicensed individual a pharmacy technician. A delegate pharmacy product verification technician may not conduct product verification as part of the final check of their own product preparation.

Phar 7.14 (1) (d) “Supervising pharmacist” means the pharmacist licensed in this state, who is responsible for the operations and outcomes of product verification done by a delegate pharmacy product verification technician and ensuring for direct supervision of the delegate pharmacy product verification technician.

Phar 7.14 (2) Delegate Pharmacy product verification technician qualifications. A pharmacist may delegate the product verification of a prescription or chart order to a delegate pharmacy technician who meets all of the following:

SECTION 5. Phar 7.14 (2) (a) is repealed.

SECTION 6. Phar 7.14 (2) (b), (2) (c) 3. and 6., (2) (d) 1. and 2., and (2) (e); 7.14 (3) (a) and (b); 7.14 (4) (a), (b), (b) 1., (c), and (d); 7.14 (5); and 7.14 (6) (a) 1. and 2. are amended to read:

Phar 7.14 (2) (b) Completed an accredited pharmacy technician training program or has a minimum of 500 hours of experience in product selection, labeling and packaging.

Phar 7.14 (2) (c) 3. Eligible medications products for delegate-check-delegate pharmacy product verification technician-check-pharmacy technician.

Phar 7.14 (2) (c) 6. A practical training designed to assess the competency of the delegate pharmacy technician prior to starting the validation process. The practical training shall include simulation of at least 2 occurrences of each of the following:

Phar 7.14 (2) (d) 1. The delegate pharmacy technician being validated shall make a product verification on the work of a pharmacist or unlicensed person another pharmacy technician for accuracy and correctness of a minimum of 500 product verifications over a minimum of 5 separate days and achieve an accuracy rate of at least 99.8%.

Phar 7.14 (2) (d) 2. A pharmacist shall audit 100% of the product verifications made by the delegate pharmacy technician during the validation process.

Phar 7.14 (2) (e) Notwithstanding pars. (a) (b) to (d), a delegate an individual who completed the board’s pilot program validation process between October 1, 2016 and September 30, 2019, meets the delegation pharmacy product verification technician qualifications unless the delegate individual fails to meet the quality assurance standards under sub. (4).

Phar 7.14 (3) (a) Institutional pharmacies. The delegate pharmacy product verification technician may do the product verification in an institutional pharmacy if all of the following requirements are met: