21 CFR Part 111 Subpart G (Components, Packaging, and Labels)

Subpart G of 21 CFR Part 111 (Sections 111.153-111.180) establishes requirements for the components, packaging, and labels you receive, and for product you receive for packaging or labeling as a dietary supplement. Key requirements include: written procedures for handling these materials (111.153), examination and documentation of components, packaging, and labels received (111.155-111.160), and quality-control release from quarantine before use (111.165). The packaging and labeling OPERATIONS themselves (filling, labeling, line controls, and label reconciliation) are governed separately by Subpart L (Sections 111.403-111.430). 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.