Posted on February 11, 2021
The Bureau of Professional Licensing (BPL) within the Department of Licensing and Regulatory Affairs (LARA) would like to inform you that new Pharmacy – Continuing Education and Pharmacy – General Rules were effective as of December 22, 2020.
Summaries of the notable changes are below. The summaries are not intended to provide a comprehensive listing of all changes or current requirements. Licensees should review the rules and statute for a complete understanding of all applicable requirements.
The Board of Pharmacy – Pharmacist Continuing Education rule modifications will:
The Board of Pharmacy – General Rules were substantially rewritten and reorganized to provide for rules that encompass all the necessary requirements for licensing and regulating the practice for pharmacists, interns, preceptors, pharmacies, manufacturers, and wholesale distributors. The revisions modify the parts pertaining to general provisions, pharmacist licenses, pharmacy licenses, manufacturer licenses, wholesale distributor licenses, and the practice of pharmacy.
Part 1 of the proposed pharmacy rules pertains to pharmacy services in medical institutions, definitions, resale of drugs and devices, and inspections of applicants and licensees.
Part 2 of the proposed pharmacy rules pertains to licensure of pharmacists. This part includes the rules pertaining to training for identifying victims of human trafficking, educational limited licenses, internship requirements, preceptor licenses, examinations, pharmacist licensure by examination and endorsement, and relicensure. Key changes in this part include:
Part 3 of the proposed pharmacy rules pertains to pharmacy licenses. This part includes the application requirements for pharmacies, compounding services and the adoption by reference of standards that apply to these services, inspections, discontinuance and resumption of sterile compounding services, housing of a pharmacy, professional and technical equipment and supplies, closure of a pharmacy, and relicensure. Key changes in this part include:
Part 4 of the proposed pharmacy rules pertains to manufacturer licenses. This part includes licensure requirements for manufacturers, persons to whom drugs or devices may be sold, adoption by reference of a federal regulation on good manufacturing practices for finished pharmaceuticals, closure of a manufacturer, and relicensure. Key changes in this part include:
Part 5 of the proposed pharmacy rules pertains to wholesale distributor licenses. This part includes the determination of a pharmacy as a wholesale distributor, the licensure requirements for wholesale distributors, persons to whom drugs or devices may be sold, wholesale distributor practices, recordkeeping and policy requirements for wholesale distributors, facility requirements, examination of drugs and devices, closure of a wholesale distributor, and relicensure. Key changes in this part include:
Part 6 of the proposed pharmacy rules pertains to the practice of pharmacy. This part includes prescription drug labeling and dispensing, prescription drug receipts, noncontrolled prescriptions, a customized patient medication package, prescription records, prescription refill records, automated devices, professional responsibility of a pharmacist, and hospice emergency drug boxes.
A complete copy of the new rules can be found on our website at www.michigan.gov/bpl.