CFR — Code of Federal Regulations Title 21 Part 211 Subpart E — Control of Components and Drug Product Containers and Closures § 211.82 — Receipt and storage of untested components, drug product containers, and closures.

[Code of Federal Regulations]
[Title 21, Volume 4]
[CITE: 21CFR211.82]

TITLE 21–FOOD AND DRUGS
CHAPTER I–FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C – DRUGS: GENERAL
PART 211 — CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

Subpart E – Control of Components and Drug Product Containers and Closures

Sec. 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]

As per US Health & Human Services, the information on this page is current as of Mar. 22, 2024.