§211.150. Distribution procedures.
21 C.F.R. § 211.150
Written procedures shall be established, and followed, describing the distribution of drug products. They shall include:
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.
A system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary.
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 321, 351, 352, 355, 360b, 360ddd, 360ddd-1, 371, 374; 42 U.S.C. 216, 262, 263a, 264.
Source
Source: 43 FR 45077, Sept. 29, 1978, unless otherwise noted.