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[Code of Federal Regulations]
[Title 21, Volume 4]
[CITE: 21CFR211.87]
TITLE 21–FOOD AND DRUGS
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
Sec. 211.87 Retesting of approved components, drug product containers, and closures.
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.
As per US Health & Human Services, the information on this page is current as of Mar. 22, 2024.
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