Current Good Manufacturing Practice for Dietary Supplements
The cGMP regulation for manufacturing, packaging, labeling, and holding dietary supplements. It requires identity testing of incoming dietary ingredients, established specifications, quality-control oversight, and full batch documentation — bringing pharmaceutical-style controls to the supplement industry.
Manufacturers, packagers, labelers, and holders of dietary supplements distributed in the United States.
- 01Establish specifications for identity, purity, strength, and composition
- 02Conduct identity testing on every incoming dietary ingredient
- 03Maintain a Master Manufacturing Record and a complete Batch Production Record per batch
- 04Operate an independent quality-control function that approves and rejects
- 05Investigate and document any specification failure
Issued in 2007 with a phased compliance schedule; remains the governing US cGMP for dietary supplements.
21 CFR Part 111: frequently asked questions
Quick answers to common questions about 21 CFR Part 111.
What is 21 CFR Part 111?
21 CFR Part 111 — Current Good Manufacturing Practice for Dietary Supplements — is a regulation issued by the Food and Drug Administration (United States). The cGMP regulation for manufacturing, packaging, labeling, and holding dietary supplements. It requires identity testing of incoming dietary ingredients, established specifications, quality-control oversight, and full batch documentation — bringing pharmaceutical-style controls to the supplement industry.
Who does 21 CFR Part 111 apply to?
Manufacturers, packagers, labelers, and holders of dietary supplements distributed in the United States.
What are the key requirements of 21 CFR Part 111?
FDA 21 CFR Part 111 requires, among other things: Establish specifications for identity, purity, strength, and composition; Conduct identity testing on every incoming dietary ingredient; Maintain a Master Manufacturing Record and a complete Batch Production Record per batch; Operate an independent quality-control function that approves and rejects.
When was 21 CFR Part 111 last updated?
The current version of 21 CFR Part 111 dates from June 2007. Issued in 2007 with a phased compliance schedule; remains the governing US cGMP for dietary supplements.
Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
Track the standards that move
When 21 CFR Part 111 — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.