Code of Federal Regulations · Section

§ 211.150 — Distribution Procedures

21 C.F.R. § 211.150

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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.

21 C.F.R. § 211.142

Authorizing Statute