21 CFR 111FDAactive
Current Good Manufacturing Practice for Dietary Supplements
Plain English Summary
Establishes manufacturing quality standards for dietary supplement producers to ensure product safety.
CFR Title
21
CFR Part
111
Effective Date
Jun 25, 2007
Jurisdiction
US
Full Text
Manufacturers, packagers, labelers, and holders of dietary supplements must comply with current good manufacturing practices to ensure quality. Requirements include establishing specifications for identity, purity, strength, and composition of dietary supplements, and verifying that these specifications are met.
Facilities must establish quality control procedures, maintain manufacturing records, and handle consumer complaints. The cGMPs cover personnel, physical plant and grounds, equipment, production and process controls, and laboratory operations.
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