21 CFR Part 111 Subpart G (Packaging/Labeling Operations)
RegulatoryAlso known as: Part 111 Subpart G, Supplement packaging CGMP, Packaging and labeling operations rule
The specific Part 111 regulations governing packaging and labeling operations for dietary supplements.
What It Means
Subpart G of 21 CFR Part 111 establishes requirements for packaging and labeling operations specifically. Key requirements include: written procedures for packaging and labeling operations (111.153), examination and documentation of packaging and labels received (111.155-111.160), QC release of packaging and labels from quarantine (111.165), pre-run examination against the master manufacturing record, issuance control, representative sample inspection, destruction of obsolete labels, and label reconciliation. FDA's Compliance Program 7321.008 (updated August 18, 2025) includes a packaging/labeling-only inspection track for facilities that only package/label supplements (not manufacture). The Txsyn Int LLC warning letter (July 2024) is a canonical example of Subpart G failures: no written procedures, no QC release from quarantine for received product.
What It Is Not
Subpart G is specifically about packaging and labeling OPERATIONS. It is distinct from Part 111's other subparts covering manufacturing (Subpart E), laboratory operations (Subpart J), and records (Subpart P). A facility can be FDA-registered for packaging/labeling only, without manufacturing capabilities.
Evidence and References
- regulation21 CFR Part 111 Subpart G full text
- enforcementTxsyn Int LLC warning letter (Jul 2024)
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