21 CFR 211.82 - Receipt and storage of untested 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]

§ 211.82 - Receipt and storage of untested components, drug product containers, and closures.

(a) Upon receipt and before acceptance, each container or grouping of containers of components, drug product containers, and closures shall be examined visually for appropriate labeling as to contents, container damage or broken seals, and contamination.

(b) Components, drug product containers, and closures shall be stored under quarantine until they have been tested or examined, whichever is appropriate, and released. Storage within the area shall conform to the requirements of § 211.80.

[43 FR 45077, Sept. 29, 1978, as amended at 73 FR 51932, Sept. 8, 2008]

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 211.82