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:
120 hours
6. List with description of all entities that may be affected by the proposed rule:
Licensed Pharmacies, Pharmacists, Manufacturers, and 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):
None to minimal. It is not likely to have a significant economic impact on small businesses.
Contact Person: Nilajah Hardin, Administrative Rules Coordinator, (608) 267-7139
Approved for publication: Approved for implementation:
Authorized Signature Authorized Signature
Date Submitted Date Submitted
