Code of Federal Regulations · Section
§ 201.18 — Drugs; Significance Of Control Numbers
21 C.F.R. § 201.18
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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.
Authorizing Statute
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Regulations42 U.S.C. § 216
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Definitions; generally21 U.S.C. § 321