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21 CFR 211.142 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (§ 200.5 To § 299.5) — Food And Drug Administration, Department Of Health And Human Services (Continued) (§ 200.5 To § 299.5) — Drugs: General (§ 200.5 To § 299.5) — Current Good Manufacturing Practice For Finished Pharmaceuticals (§ 211.1 To § 211.208) — Holding And Distribution (§ 211.142 And § 211.150) — Warehousing procedures.

4 Aug 2016

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 CFR 211.142