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), holding and distributing (M), and records (P). Subpart M is particularly relevant for 3PLs and warehouses: it requires dietary supplements to be held under appropriate conditions and returned supplements to be quarantined until QC review and disposition. FDA CP 7321.008 (August 2025) explicitly includes warehouse inspections for firms that hold and/or fulfill dietary supplements.
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. Part 111 also applies to holding-only facilities (3PLs, warehouses), not just manufacturers; a common misconception.
Evidence and References
- regulation21 CFR Part 111
- regulation21 CFR Part 111 Subpart M — Holding and Distributing
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