21 C.F.R. Subpart H—Holding and Distribution
Title 21 - Food and Drugs
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. 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.
Title 21: Food and Drugs
PART 211—CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
Subpart H—Holding and Distribution
§ 211.142 Warehousing procedures.
§ 211.150 Distribution procedures.
