21 USC § 353c - Prereview of television advertisements

---
identifier: "/us/usc/t21/s353c"
source: "usc"
legal_status: "official_prima_facie"
title: "21 USC § 353c - Prereview of television advertisements"
title_number: 21
title_name: "FOOD AND DRUGS"
section_number: "353c"
section_name: "Prereview of television advertisements"
chapter_number: 9
chapter_name: "FEDERAL FOOD, DRUG, AND COSMETIC ACT"
subchapter_number: "V"
subchapter_name: "DRUGS AND DEVICES"
part_number: "A"
part_name: "Drugs and Devices"
positive_law: false
currency: "119-84"
last_updated: "2026-04-17"
format_version: "1.1.0"
generator: "[email protected]"
source_credit: "(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.)"
---


# § 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** section 355 of this titlesection 262 of title 42

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  or , 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** section 352(n) of this title

Nothing in this section may be construed as having any effect on requirements under  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).

---

**Source Credit**: (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  prior to renumbering by .

## Statutory Notes and Related Subsidiaries

### Effective Date

Section effective 180 days after , see , set out as an Effective Date of 2007 Amendment note under .