Section R. 338.533 - Compounding standards and requirements; outsourcing facilities; requirementsRule 33.
(1) The board approves and adopts by reference the compounding standards of USP, published by the United States Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, Maryland 20852-1790. This includes USP Chapters 795 (revised 2023) and 797 (revised 2023), with the exception of flavoring.(2) The standards adopted by reference in subrule (1) of this rule are available at a cost of $250.00 at http://www.usp.org/compounding, or can be viewed at the Bureau of Professional Licensing, Michigan Department of Licensing and Regulatory Affairs, Ottawa Building, 611 West Ottawa, P.O. Box 30670, Lansing, Michigan 48909.(3) A pharmacy that provides compounding services shall comply with the standards adopted in subrule (1) of this rule.(4) An outsourcing facility located outside of this state that dispenses, provides, distributes, or otherwise furnishes compounded pharmaceuticals in this state shall be inspected and registered as an outsourcing facility by the FDA before applying for a pharmacy license in this state.(5) An outsourcing facility located within this state that is applying for licensure as a pharmacy 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 adherence to the current and as amended good manufacturing practices for finished pharmaceuticals set forth in 21 CFR 211.1 to 211.208.(6) An outsourcing facility shall do all of the following: (a) Compound drugs by or under the supervision of a licensed pharmacist.(b) Compound drugs under current good manufacturing practices for finished pharmaceuticals set forth in 21 CFR 211.1 to 211.208.(c) Ensure that a pharmacist who conducts or oversees compounding at an outsourcing facility is proficient in the practice of compounding and has acquired the education, training, and experience to maintain that proficiency by doing any of the following: (i) Participating in seminars.(ii) Studying appropriate literature.(iii) Consulting with colleagues.(iv) Being certified by a compounding certification program approved by the board.(d) Label compounded drugs and compounded drugs that are patient specific in compliance with the requirements in R 338.582 and include all of the following:(i) Required drug and ingredient information.(ii) Facility identification.(iii) The following or similar statement: "This is a compounded drug. For office use only" or "Not for resale."(e) Ensure that bulk drug substances used for compounding meet specified FDA criteria.(7) An outsourcing facility may compound drugs that appear on an FDA shortage list, if the bulk drug substances used to compound the drugs comply with the criteria specified in this rule.Mich. Admin. Code R. 338.533
2020 AACS; 2022 AACS; 2024 MR 5, Eff. 2/29/2024