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21CFR201.18

§ 201.18 Drugs; significance of control numbers.

Regulation 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.

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.

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21CFR201.18 — § 201.18 Drugs; significance of control numbers. | CFR Explorer | BioRegHub