21 USC 355b - Adverse-event reporting

U.S Code last checked for updates: Apr 28, 2024

§ 355b.

Adverse-event reporting

(a)

Toll-free number in labeling

Not later than one year after January 4, 2002, the Secretary of Health and Human Services shall promulgate a final rule requiring that the labeling of each drug for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355] (regardless of the date on which approved) include the toll-free number maintained by the Secretary for the purpose of receiving reports of adverse events regarding drugs and a statement that such number is to be used for reporting purposes only, not to receive medical advice. With respect to the final rule:

(1)

The rule shall provide for the implementation of such labeling requirement in a manner that the Secretary considers to be most likely to reach the broadest consumer audience.

(2)

In promulgating the rule, the Secretary shall seek to minimize the cost of the rule on the pharmacy profession.

(3)

The rule shall take effect not later than 60 days after the date on which the rule is promulgated.

(b)

Drugs with pediatric market exclusivity

(1)

In general

(2)

Rule of construction

(Pub. L. 107–109, § 17, Jan. 4, 2002, 115 Stat. 1422; Pub. L. 108–155, § 3(b)(5), Dec. 3, 2003, 117 Stat. 1942.)

cite as: 21 USC 355b