Regulations last checked for updates: Feb 07, 2026

Title 21 - Food and Drugs last revised: Dec 18, 2026
§ 201.18 - Drugs; significance of control numbers.

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.

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: 40 FR 13998, Mar. 27, 1975, unless otherwise noted.
cite as: 21 CFR 201.18