usc:us:21:353c

text: U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2024 Edition Title 21 - FOOD AND DRUGS CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT SUBCHAPTER V - DRUGS AND DEVICES Part A - Drugs and Devices Sec. 353c - Prereview of television advertisements From the U.S. Government Publishing Office, www.gpo.gov §353c. Prereview of television advertisements (a) In general The Secretary may require the submission of any television advertisement for a drug (including any script, story board, rough, or a completed video production of the television advertisement) to the Secretary for review under this section not later than 45 days before dissemination of the television advertisement. (b) Review In conducting a review of a television advertisement under this section, the Secretary may make recommendations with respect to information included in the label of the drug— (1) on changes that are— (A) necessary to protect the consumer good and well-being; or (B) consistent with prescribing information for the product under review; and (2) if appropriate and if information exists, on statements for inclusion in the advertisement to address the specific efficacy of the drug as it relates to specific population groups, including elderly populations, children, and racial and ethnic minorities. (c) No authority to require changes Except as provided by subsection (e), this section does not authorize the Secretary to make or direct changes in any material submitted pursuant to subsection (a). (d) Elderly populations, children, racially and ethnically diverse communities In formulating recommendations under subsection (b), the Secretary shall take into consideration the impact of the advertised drug on elderly populations, children, and racially and ethnically diverse communities. (e) Specific disclosures (1) Serious risk; safety protocol In conducting a review of a television advertisement under this section, if the Secretary determines that the advertisement would be false or misleading without a specific disclosure about a serious risk listed in the labeling of the drug involved, the Secretary may require inclusion of such disclosure in the advertisement. (2) Date of approval In conducting a review of a television advertisement under this section, the Secretary may require the advertisement to include, for a period not to exceed 2 years from the date of the approval of the drug under section 355 of this title or section 262 of title 42, a specific disclosure of such date of approval if the Secretary determines that the advertisement would otherwise be false or misleading. (f) Rule of construction Nothing in this section may be construed as having any effect on requirements under section 352(n) of this title or on the authority of the Secretary under section 314.550, 314.640, 601.45, or 601.94 of title 21, Code of Federal Regulations (or successor regulations). (June 25, 1938, ch. 675, §503C, formerly §503B, as added Pub. L. 110–85, title IX, §901(d)(2), Sept. 27, 2007, 121 Stat. 939, renumbered §503C, Pub. L. 113–54, title I, §102(a)(1), Nov. 27, 2013, 127 Stat. 587.) Editorial Notes Codification Section was formerly classified to section 353b of this title prior to renumbering by Pub. L. 113–54. Statutory Notes and Related Subsidiaries Effective Date Section effective 180 days after Sept. 27, 2007, see section 909 of Pub. L. 110–85, set out as an Effective Date of 2007 Amendment note under section 331 of this title.