Code of Federal Regulations · Section

§ 211.142 — Warehousing Procedures

21 C.F.R. § 211.142

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Written procedures describing the warehousing of drug products shall be established and followed. They shall include:

(a) Quarantine of drug products before release by the quality control unit.

(b) Storage of drug products under appropriate conditions of temperature, humidity, and light so that the identity, strength, quality, and purity of the drug products are not affected.

21 C.F.R. § 211.150

Authorizing Statute

Definitions; generally
21 U.S.C. § 321
Regulations
42 U.S.C. § 216