21 Code of Federal Regulations Parts 211 Subpart H-Holding and Distribution

21 Code of Federal Regulations

Parts 211

Subpart H-Holding and Distribution

§ 211.142 Warehousing procedures.

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.

§ 211.150 Distribution procedures.

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

(a) A procedure whereby the oldest approved stock of a drug product is distributed first. Deviation from this requirement is permitted if such deviation is temporary and appropriate.

(b) A system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary.

Comments

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