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.
21 CFR Part 201 · Labeling
§ 201.18 Drugs; significance of control numbers
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Warning letters citing § 201.18
2 FDA warning letters since 2017 cite this section :
- Kalchem International, Inc. 27 Aug 2020
- Prosana Distribuciones SA de CV 17 Dec 2017
FDA guidance that cites § 201.18
- Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors 18 May 2022
- Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages: Guidance for Industry 28 Feb 2010
- Labeling OTC Human Drug Products -- Questions and Answers 5 Jan 2009
- CVM GFI #45 Guideline for Uniform Labeling of Drugs for Dairy and Beef Cattle 31 Jul 1993
Amendment history
Federal Register documents that created or amended this section.
- 40 FR 13998 27 Mar 1975