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 CFR Part 211 · Current Good Manufacturing Practice for Finished Pharmaceuticals
§ 211.87 Retesting of approved components, drug product containers, and closures
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
What FDA inspectors cite under § 211.87
Form FDA 483 observations citing this section, fiscal years 2009–2024 (Drugs).
- Retest of approved components/containers/closures 60
Warning letters citing § 211.87
2 FDA warning letters since 2017 cite this section :
- Cosco International, Inc. 14 Apr 2025
- Advanced Nutriceuticals, LLC dba The Guyer Institute of Molecular Medicine 10 Nov 2021
FDA guidance that cites § 211.87
- Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry: Draft Guidance for Industry draft 22 Jan 2020
- BLA for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System: Guidance for Industry 1 Mar 2014
- Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations 2 Oct 2006
Amendment history
Federal Register documents that created or amended this section.
- 43 FR 45077 29 Sept 1978