21 CFR 201.18
§ 201.18 Drugs; significance of control numbers.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 201.18, § 201.18 Drugs; significance of control numbers, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/85758
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Full text
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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.