21 CFR 211.89 - Rejected components, drug product containers, and closures.

Regulations last checked for updates: Oct 17, 2024

Title 21 - Food and Drugs last revised: Oct 15, 2024

View all text of Subpart E [§ 211.80 - § 211.94]

§ 211.89 - Rejected components, drug product containers, and closures.

Rejected components, drug product containers, and closures shall be identified and controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable.

authority: 21 U.S.C. 321,351,352,355,360b,371,374; 42 U.S.C. 216,262,263a,264

source: 43 FR 45077, Sept. 29, 1978, unless otherwise noted.

cite as: 21 CFR 211.89