Section R. 338.532 - Sterile compounding accrediting organizations; board approval; inspection entitiesRule 32.
(1) The board shall approve, under section 17748a of the code, MCL 333.17748a, accrediting organizations or inspection entities for pharmacies that compound pharmaceuticals according to standards adopted by reference in R 338.533.(2) The department shall post on its website, the list of organizations approved under subrule (1) of this rule.(3) An organization may petition the board for approval under subrule (1) of this rule. The petition must include, but is not limited to, all of the following: (a) Requirements for accreditation or compliance.(b) Requirements for inspectors.(c) Training provided to inspectors.(d) Copy of the most current inspection form.(e) The length of accreditation.(f) Agreement and plan to share results of inspections with the department.(4) If the board approves the petition, the approval is valid for 3 years after the date of approval. The organization may submit a petition that complies with subrule (3) of this rule to seek continuing approval.(5) The board may rescind approval of an organization upon just cause. The rescission will not immediately affect the compliance of a pharmacy using the accreditation. Within 12 months after the rescission date or by the next licensure renewal date, whichever is later, the accreditation is void, and a pharmacy shall obtain accreditation or an inspection from an organization that satisfies subrule (1) of this rule.Mich. Admin. Code R. 338.532
2020 AACS; 2024 MR 5, Eff. 2/29/2024