450.02 (3) (e) 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:
200 hours
6. List with description of all entities that may be affected by the proposed rule:
Pharmacies, including pharmacies located within hospitals, 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 states are primarily responsible for the oversight of compounding in pharmacies. Pursuant to the Drug Quality and Security Act, the federal government is responsible for outsourcing facilities, which by definition are not pharmacies, and are subject to current good manufacturing practice requirements, labeling requirements and may distribute compunded drugs in response to an order that is not patient specific.
The Food, Drug and Cosmetic Act requires drugs to be prepared, packed or held under sanitary conditions.
8. Anticipated economic impact of implementing the rule (note if the rule is likely to have a significant economic impact on small businesses):
Moderate economic impact. It may have an economic impact on small businesses.
Contact Person: Sharon Henes, Administrative Rules Coordinator, (608) 261-2377
Authorized Signature
February 27, 2019
Date Submitted
