1. Regulations
  2. title 21
  3. chapter I-i3
  4. part 201
  5. subpart A
  6. § 201.18

View all text of Subpart A [§ 201.1 - § 201.26]

§ 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.

AUTHORITY: 21 U.S.C. 321, 331, 343, 351, 352, 353, 355, 358, 360, 360b, 360ccc, 360ccc-1, 360ee, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.

SOURCE: 40 FR 13998, Mar. 27, 1975, unless otherwise noted.

CITE AS: 21 CFR 201.18