C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER C—DRUGS: GENERAL › PART 211—CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS › Subpart E—Control of Components and Drug Product Containers and Closures

21 C.F.R. § 211.87

Retesting of approved components, drug product containers, and closures

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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.

Notes of Decisions
Cited in 1 case (1 in the last 5 years), 2025–2025 · leading case: Daugherty v. Padagis Israel Pharm. Ltd. (N.D. Cal. 2025).
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Daugherty v. Padagis Israel Pharm. Ltd. (N.D. Cal. 2025). · cites it 2× “FAC ¶ 68(o); see 21 C.F.R. § 211.87 . This 16 regulation provides: 17 Components, drug product containers, and closures shall be retested 18 or reexamined, as appropriate, for identity, strength, quality, and 19 purity and approved or rejected by the quality control unit in…”
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