21 CFR 211.87: Retesting of approved components, drug product containers, and closures
Requires manufacturers to retest or reexamine approved components, containers, and closures as appropriate, such as after long storage or adverse exposure, with the quality control unit approving or rejecting them again.
Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals · Subpart E, Control of Components and Drug Product Containers and Closures
How FDA words it
The opening lines investigators use most when they cite 211.87, from the 483s we hold.
Approved components are not retested or reexamined as appropriate for identity, strength, quality and purity after storage for long periods with subsequent approval or rejection by the quality control unit.Most used
Approved com ponents, drug product containers and closures are not retested or reexam ined as appropriate for identity, strength, quality and purity after sto rage for long periods with subsequent approval or rejection by the…
Cited over time
483s citing 211.87, by yearMost citations in 2018. Bars are relative to the busiest year. *2026 to date.
Years shown: 2017 to 2026. The busiest year was 2018.
Recent 483s citing 211.87
- Delta Pharma, Inc · Ripley, MississippiApproved components are not retested or reexamined as appropriate for identity,… Nov 21, 2025
- Brands International Corporation · Newmarket, CanadaProcedures designed to assure conformance to written specifications do not require… Jun 21, 2024
- ARG Laboratories, Inc · Dallas, TexasApproved components and drug product containers are not retested or reexamined as… Sep 20, 2023
- Chunghwa Chemical Synthesis & Biotech Co., Ltd · New Taipei City, TaiwanThe retest date for T<"> the key starting material for the active pharmaceutical… Nov 18, 2022
- Olympia Compounding Pharmacy · Orlando, FloridaApproved components, diug product containers and closures are not retested or… Mar 2, 2022
The regulation text
§ 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.
Questions
What does 21 CFR 211.87 require?
Requires manufacturers to retest or reexamine approved components, containers, and closures as appropriate, such as after long storage or adverse exposure, with the quality control unit approving or rejecting them again.
How do FDA investigators word a 211.87 observation?
The most common opening is: “Approved components are not retested or reexamined as appropriate for identity, strength, quality and purity after storage for long periods with subsequent approval or rejection by the quality control unit.”
Which sections are cited alongside 211.87?
In the same 483s, investigators most often also cite 211.165 (Testing and release for distribution), 211.166 (Stability testing), 211.160 (General requirements), 211.22 (Responsibilities of quality control unit).