Pub. L. 115-234, tit. III, sec. 303 (as amended)
MISBRANDED DRUGS AND DEVICES.
SEC. 303. MISBRANDED DRUGS AND DEVICES.
(a) In General.—Section 502(w) (21 U.S.C. 352(w)) is amended—
(1) in subparagraph (1), by striking “; or” and inserting “;”;
(2) in subparagraph (2), by striking the period and inserting “; or”; and
(3) by adding at the end the following:
“(3) for which an application has been approved under section 512 and the labeling of such drug does not include the application number in the format: ‘Approved by FDA under (A)NADA # xxx-xxx’, except that this subparagraph shall not apply to representative labeling required under section 514.1(b)(3)(v)(b) of title 21, Code of Federal Regulations (or any successor regulation) for animal feed bearing or containing a new animal drug.”
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(b) [21 U.S.C. 352 note] Applicability.—Section 502(w)(3) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), shall apply beginning on September 30, 2023.
- Cross-references to the US Code
- 21 U.S.C. 352 note