§201.18. Drugs; significance of control numbers.
21 C.F.R. § 201.18
The lot number on the label of a drug should be capable of yielding the complete manufacturing history of the package. An incorrect lot number may be regarded as causing the article to be misbranded.
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 321, 331, 343, 351, 352, 353, 355, 358, 360, 360b, 360ccc, 360ccc-1, 360ddd, 360ddd-1, 360ee, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.
Source
Source: 40 FR 13998, Mar. 27, 1975, unless otherwise noted.