§ 355b. Adverse-event reporting
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/usc/title-21/section-355bA research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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.
(Pub. L. 107–109, § 17, Jan. 4, 2002, 115 Stat. 1422; Pub. L. 108–155, § 3(b)(5), Dec. 3, 2003, 117 Stat. 1942.)
Connections8 cite this · traces to 5
Cited by 8 sections
statutes-at-large
- Public Law 107–109To amend the Federal Food, Drug, and Cosmetic Act to improve the safety and efficacy of pharmaceuticals for children
- Public Law 110–85To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes
- Public Law 108–155To amend the Federal Food, Drug, and Cosmetic Act to authorize the Food and Drug Administration to require certain research into drugs used in pediatric patients
- Public Law 111–148Entitled The Patient Protection and Affordable Care Act
statute-compilations
10 references not yet in our index
- 1
- 2
- Pub. L. 107–109, § 17
- 115 Stat. 1422
- Pub. L. 108–155, § 3(b)(5)
- 117 Stat. 1942
- act June 25, 1938, ch. 675
- 52 Stat. 1040
- Pub. L. 108–155
- section 4 of Pub. L. 108–155
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cites case law
§ 355b
Adverse-event reporting
Stat.×4
Fed. Reg.×3
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Cite1
Cite2
Pub. L.Pub. L. 107–109, § 17
Stat.115 Stat. 1422
Pub. L.Pub. L. 108–155, § 3(b)(5)
Cites 15 · showing 10Cited by 8 across 3 sources