Statutes, codes, and regulations
Michigan Administrative Code
Department - Licensing and Regulatory AffairsBureau of Professional LicensingBoard of PharmacyBoard of Pharmacy - General RulesPHARMACY SERVICES IN MEDICAL INSTITUTIONS
Part 4 - MANUFACTURER LICENSE
Section R. 338.555 - Federal regulation on good manufacturing practice for finished pharmaceuticals; adoption by reference; compliance

Mich. Admin. Code R. 338.555

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Current through Vol. 24-22, December 15, 2024
Section R. 338.555 - Federal regulation on good manufacturing practice for finished pharmaceuticals; adoption by reference; compliance

Rule 55.

(1) The board approves and adopts by reference the current and as amended good manufacturing practice for finished pharmaceuticals regulations set forth in 21 CFR 211.1 to 211.208 (2022).
(2) A manufacturer shall comply with the standards adopted in subrule (1) of this rule.
(3) The standards adopted by reference in subrule (1) of this rule are available at no cost at

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=211, or at 10 cents per page from the Board of Pharmacy, Bureau of Professional Licensing, Michigan Department of Licensing and Regulatory Affairs, Ottawa Building, 611 West Ottawa, P.O. Box 30670, Lansing, Michigan 48909.

Mich. Admin. Code R. 338.555

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