Statement of Scope
PHARMACY EXAMINING BOARD
Rule No.: | Phar 1, 5, 6, 7, and 8 |
Relating to: | Remote Dispensing |
Rule Type: | Permanent and Emergency |
1. Finding/nature of emergency (Emergency Rule only):
“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. Notwithstanding s. 227.24 (1) (a) and (3), the examining board is not required to provide evidence that promulgating a rule under this subsection as an emergency rule is necessary for the preservation of the public peace, health, safety, or welfare and is not required to provide a finding of emergency for a rule promulgated under this subsection.” 2. Detailed description of the objective of the proposed rule:
3. Description of the existing policies relevant to the rule, new policies proposed to be included in the rule, and an analysis of policy alternatives:
The Board intends to update the Pharmacy code to bring it into alignment with 2021 Wisconsin Act 101. An alternative would be to not revise the code to reflect these new requirements, which would create confusion and a lack of clarity for stakeholders as to what is required of pharmacists and the board as it relates to the new statutory requirements. 4. Detailed explanation of statutory authority for the rule (including the statutory citation and language):
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.” 5. Estimate of amount of time that state employees will spend developing the rule and of other resources necessary to develop the rule:
Approximately 100 hours
6. List with description of all entities that may be affected by the proposed rule:
Pharmacies and pharmacists
7. Summary and preliminary comparison with any existing or proposed federal regulation that is intended to address the activities to be regulated by the proposed rule:
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.
8. Anticipated economic impact of implementing the rule (note if the rule is likely to have a significant economic impact on small businesses):
None to minimal. It is not likely to have a significant economic impact on small businesses.
