21 C.F.R. § 211.87
Retesting of approved components, drug product containers, and closures.
Cite as 21 C.F.R. § 211.87 (2026)
Components, drug product containers, and closures shall be retested or reexamined, as appropriate, for identity, strength, quality, and purity and approved or rejected by the quality control unit in accordance with § 211.84 as necessary, e.g., after storage for long periods or after exposure to air, heat or other conditions that might adversely affect the component, drug product container, or closure.
- Cross-references to the CFR
- 211.84