Sec. 2. Adverse event reporting
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Subchapter H of chapter VII of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379aa et seq.) is amended by adding at the end the following: In this section: The term adverse event means any health-related event associated with the use of a cosmetic that is adverse. The term serious adverse event means an adverse event that— results in— death; a life-threatening experience; inpatient hospitalization; a persistent or significant disability, incapacity, or disfigurement; a congenital abnormality or birth defect; or permanent alteration of appearance other than as intended, under conditions of use that are customary or usual; or requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described in subparagraph (A).
The term serious adverse event report means a report that is required to be submitted to the Secretary under subsection (b). The manufacturer or distributor of a cosmetic whose name appears on the label of such cosmetic pursuant to section 602 (referred to in this section as a responsible person ) shall submit to the Secretary any report received of a serious adverse event associated with such cosmetic when used in the United States, accompanied by a copy of the label on or within the retail packaging of such cosmetic.
The responsible person shall submit to the Secretary a serious adverse event report no later than 15 business days after the report is received. The responsible person shall submit to the Secretary any new and material medical information, related to a submitted serious adverse event report that is received by the responsible person within 1 year of the initial report, no later than 15 business days after such information is received by such responsible person. The Secretary shall provide for systems to enable responsible persons to submit a single report that includes duplicate reports of, or new medical information related to, a serious adverse event.
The Secretary may establish an exemption to the requirements under paragraphs
(1)and
(2)if— the Secretary receives a report in accordance with section 760; or after providing notice and an opportunity for comment from interested parties, the Secretary determines that such exemption would have no significant adverse effect on public health. Each serious adverse event report under this section shall be submitted to the Secretary, and may be accompanied by additional information. The responsible person shall maintain records related to each report of a serious adverse event received by the responsible person for a period of 6 years. The responsible person shall permit an authorized person to have access to records required to be maintained under this section during an inspection pursuant to section 704. For purposes of this paragraph, the term authorized person means an officer or employee of the Department of Health and Human Services, who has— appropriate credentials, as determined by the Secretary; and been duly designated by the Secretary to have access to the records required under this section. A serious adverse event report submitted to the Secretary under this section, including any new medical information submitted under subsection (c)(2), or an adverse event report voluntarily submitted to the Secretary shall be considered to be— a safety report under section 756 and may be accompanied by a statement, which shall be a part of any report that is released for public disclosure, that denies that the report or the records constitute an admission that the product involved caused or contributed to the adverse event; and a record about an individual under section 552a of title 5, United States Code (commonly referred to as the Privacy Act of 1974 ), and a medical or similar file the disclosure of which would constitute a violation of section 552 of such title 5 (commonly referred to as the Freedom of Information Act ), and shall not be publicly disclosed unless all personally identifiable information is redacted. The submission of any adverse event report under this section shall not be construed as an admission that the cosmetic involved caused or contributed to the adverse event. No State or local government shall establish or continue in effect any law, regulation, order, or other requirement related to a mandatory system for adverse event reports for cosmetics. Nothing in this section shall affect the authority of the Secretary to provide adverse event reports and information to any health, food, or drug officer or employee of any State, territory, or political subdivision of a State or territory, under a memorandum of understanding between the Secretary and such State, territory, or political subdivision. Notwithstanding any other provision of law, personally-identifiable information in adverse event reports provided by the Secretary to any health, food, or drug officer or employee of any State, territory, or political subdivision of a State or territory, shall not— be made publicly available pursuant to any State or other law requiring disclosure of information or records; or otherwise be disclosed or distributed to any party without the written consent of the Secretary and the person submitting such information to the Secretary. Nothing in this section shall permit a State, territory, or political subdivision of a State or territory, to use any safety report received from the Secretary in a manner inconsistent with subsection
(g)or section 756. There are authorized to be appropriated to carry out this section such sums as may be necessary. . The Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 et seq.) is amended— in section 301(ii) ( 21 U.S.C. 331(ii) ), by striking section 760 or 761 each place it appears and inserting section 760, 761, or 762 ; and in section 801 ( 21 U.S.C. 381 ), by striking section 760 or 761 each place it appears in subsections
(a)and
(b)and inserting section 760, 761, or 762 .
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