Section R. 338.534a - In-state initial pharmacy license inspectionsRule 34a.
(1) An in-state pharmacy that will not compound sterile pharmaceutical products that is applying for initial licensure shall be inspected by the department or its designee before licensure.(2) An applicant for an in-state pharmacy license that intends to compound sterile pharmaceutical products shall complete both of the following: (a) Obtain an inspection from the department or its designee for the purpose of meeting R 338.536 and R 338.537 for initial licensure.(b) Within 6 months after initial licensure under this subrule, a pharmacy shall obtain, and provide to the department, a subsequent inspection to assess USP compliance or achieve accreditation from 1 of the entities listed in R 338.534(2)(a) to (c).(3) Approval to engage in sterile compounding will end 6 months after initial licensure if a subsequent inspection to assess USP compliance or accreditation is not successful.Mich. Admin. Code R. 338.534a
2024 MR 5, Eff. 2/29/2024