Mich. Admin. Code R. 338.534a - In-state initial pharmacy license inspections
Rule 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.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.