§ 355b. Adverse-event reporting

Footnotes

1. 1 So in original. Probably should be preceded by “section”.
2. 2 So in original. Probably should be “Committee”.

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1. 2002

   Best Pharmaceuticals for Children Act

   Pub. L. 107–109 § 17 · 115 Stat. 1408

   Enacted · 21 U.S.C. § 355b

   Pub. L. 107–109, § 17, Jan. 4, 2002, 115 Stat. 1422

   Source evidence

   Code source credit
   Pub. L. 107–109, § 17, Jan. 4, 2002, 115 Stat. 1422

   Enacted provision · exact public law section
   SEC. 17. ADVERSE-EVENT REPORTING. (a) Toll-Free Number in Labeling.— Not later than one year after the date of the enactment of this Act, 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 (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 of the Federal Food, Drug, and Cosmetic Act, 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 6 of this Act. In considering the report, the Director of such Office shall provide for the review of the report by the Pediatric Advisory Subcommittee of the Anti-Infective Drugs Advisory Committee, including obtaining any recommendations of such subcommittee regarding whether the Secretary should take action under the Federal Food, Drug, and Cosmetic Act 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.

2. 2003

   Pediatric Research Equity Act of 2003

   Pub. L. 108–155 § 3(b)(5) · 117 Stat. 1936

   Struck · 21 U.S.C. § 355b(b)(1)

   Pub. L. 108–155 struck out “Advisory Subcommittee of the Anti-Infective Drugs” before “Advisory Committee”

   Source evidence

   Code amendment note
   Subsec. (b)(1). Pub. L. 108–155 struck out “Advisory Subcommittee of the Anti-Infective Drugs” before “Advisory Committee”.

   Enacted provision · exact public law section
   (5) Section 17(b)(1) of the Best Pharmaceuticals for Children Act (21 U.S.C. 355b(b)(1)) is amended in the second sentence by striking “Advisory Subcommittee of the Anti-Infective Drugs”.

   Effective date note
   Amendment by Pub. L. 108–155 effective Dec. 3, 2003, except as otherwise provided, see section 4 of Pub. L. 108–155, set out as an Effective Date note under section 355c of this title.

2 of 2 references resolved to an enrolled provision