21 U.S.C. § 355b : US Code - Section 355B: Adverse-event reporting

Search 21 U.S.C. § 355b : US Code - Section 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
During the one year beginning on the date on which a drug
receives a period of market exclusivity under 505A (!1) of the
Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355a], any report
of an adverse event regarding the drug that the Secretary of
Health and Human Services receives shall be referred to the
Office of Pediatric Therapeutics established under section 393a
of this title. In considering the report, the Director of such
Office shall provide for the review of the report by the
Pediatric Advisory Committee, including obtaining any
recommendations of such subcommittee (!2) regarding whether the
Secretary should take action under the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 301 et seq.] in response to the report.
(2) Rule of construction
Paragraph (1) may not be construed as restricting the authority
of the Secretary of Health and Human Services to continue
carrying out the activities described in such paragraph regarding
a drug after the one-year period described in such paragraph
regarding the drug has expired.