21 USC 353c - Prereview of television advertisements

U.S Code last checked for updates: May 02, 2024

§ 353c.

Prereview of television advertisements

(a)

In general

(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

(d)

Elderly populations, children, racially and ethnically diverse communities

(e)

Specific disclosures

(1)

Serious risk; safety protocol

(2)

Date of approval

(f)

Rule of construction

(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.)

cite as: 21 USC 353c