Mich. Admin. Code R. 338.534

Current through Vol. 24-18, October 15, 2024
Section R. 338.534 - Out-of-state pharmacy licensure inspection; in-state pharmacy licensure renewal inspection

Rule 34.

(1) A pharmacy located outside of this state that applies for licensure in this state as a pharmacy that will not ship compounded sterile pharmaceutical products into this state shall submit to the department a copy of its most recent resident state board of pharmacy inspection or an NABP-VPP inspection that was performed within the last 2 years before the date of application.
(2) Unless accredited by a national accrediting organization, recognized by the board, an applicant for renewal of an in-state pharmacy license, or an applicant for an initial or renewal of an out-of-state pharmacy license, that will provide sterile compounded pharmaceuticals in this state shall have an inspection and submit the inspection report to the department, completed no more than 18 months before the date of application, that demonstrates compliance with all applicable standards that are adopted by reference in R 338.533. The inspection must be conducted by 1 of the following:
(a) The department.
(b) The NABP-VPP.
(c) An accrediting organization according to R 338.532.
(d) A state licensing agency of the state in which the applicant is a resident and in accordance with the NABP's multistate pharmacy inspection blueprint program.

Mich. Admin. Code R. 338.534

2020 AACS; 2022 AACS; 2024 MR 5, Eff. 2/29/2024