---
kind: "section"
citation: "21 C.F.R. § 201.18"
title: "21"
number: "201.18"
heading: "Drugs; significance of control numbers."
url: "https://uscodex.org/cfr/21/201.18"
---

# §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.


## Notes

### 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.