Code of Federal Regulations · Section

§ 211.87 — Retesting Of Approved Components, Drug Product Containers, And Closures

21 C.F.R. § 211.87

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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.

21 C.F.R. § 211.86 21 C.F.R. § 211.89

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