21 CFR 213.89 - Rejected components, incoming designated medical gases, and medical gas containers and closures.

Regulations last checked for updates: Jan 11, 2026

Title 21 - Food and Drugs last revised: Dec 18, 2026

View all text of Subpart E [§ 213.80 - § 213.94]

§ 213.89 - Rejected components, incoming designated medical gases, and medical gas containers and closures.

Rejected components, incoming designated medical gases, and medical gas 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 and shall be documented and assessed.

authority: 21 U.S.C. 321,351,352,353,355,360b,360ddd,360ddd-1,371,374

source: 89 FR 51770, June 18, 2024, unless otherwise noted.

cite as: 21 CFR 213.89