21 CFR Part 111
RegulatoryAlso known as: Part 111, Dietary Supplement CGMP Rule
The specific FDA regulation governing dietary supplement manufacturing practices.
What It Means
Title 21, Code of Federal Regulations, Part 111 establishes the current good manufacturing practice requirements for dietary supplement manufacturing. It applies to all domestic and foreign facilities that manufacture, package, label, or hold dietary supplements for sale in the US. Subparts cover: personnel (B), physical plant (C), equipment (D), production/process controls (E-G), laboratory operations (J), and records (P).
What It Is Not
Part 111 covers supplements only. Drug manufacturing follows Parts 210/211 (stricter). Food manufacturing follows Part 117. These are different regulatory frameworks with different requirements — holding one does not satisfy the other.
Evidence and References
- regulation21 CFR Part 111
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