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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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.