450.02 (3) (b) The Board may promulgate rules establishing security standards for pharmacies.
450.02 (3) (d) The Board may promulgate rules necessary for the administration and enforcement of this chapter and ch. 961. 450.02 (3) (e) The Board may promulgate rules establishing minimum standards for the practice of pharmacy.
961.31 The pharmacy examining board may promulgate rules relating to the manufacture, distribution and dispensing of controlled substances within this state.
5. Estimate of amount of time that state employees will spend developing the rule and of other resources necessary to develop the rule:
150 hours
6. List with description of all entities that may be affected by the proposed rule:
Pharmacies, pharmacists, manufacturers and wholesale distributors.
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):
Minimal to moderate. It is not likely to have a significant economic impact on small businesses.
Contact Person: Sharon Henes, Administrative Rules Coordinator, (608) 261-2377
Authorized Signature
April 16, 2019
Date Submitted
