21 U.S.C. § 379aa
In this section:
The term "adverse event" means any health-related event associated with the use of a nonprescription drug that is adverse, including-
The term "nonprescription drug" means a drug that is-
The term "serious adverse event" is an adverse event that-
The term "serious adverse event report" means a report that is required to be submitted to the Secretary under subsection (b).
The manufacturer, packer, or distributor whose name (pursuant to section 352(b)(1) of this title) appears on the label of a nonprescription drug marketed in the United States (referred to in this section as the "responsible person") shall submit to the Secretary any report received of a serious adverse event associated with such drug when used in the United States, accompanied by a copy of the label on or within the retail package of such drug.
A retailer whose name appears on the label described in paragraph (1) as a distributor may, by agreement, authorize the manufacturer or packer of the nonprescription drug to submit the required reports for such drugs to the Secretary so long as the retailer directs to the manufacturer or packer all adverse events associated with such drug that are reported to the retailer through the address or telephone number described in section 352(x) of this title.
The responsible person shall submit to the Secretary a serious adverse event report no later than 15 business days after the report is received through the address or phone number described in section 352(x) of this title.
The responsible person shall submit to the Secretary any new 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 the new information is received by the responsible person.
The Secretary shall develop systems to ensure that duplicate reports of, and new medical information related to, a serious adverse event shall be consolidated into a single report.
The Secretary, after providing notice and an opportunity for comment from interested parties, may establish an exemption to the requirements under paragraphs (1) and (2) if the Secretary determines that such exemption would have no adverse effect on public health.
Each serious adverse event report under this section shall be submitted to the Secretary using the MedWatch form, which may be modified by the Secretary for nonprescription drugs, and may be accompanied by additional information.
The responsible person shall maintain records related to each report of an 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 374 of this title.
For purposes of this paragraph, the term "authorized person" means an officer or employee of the Department of Health and Human Services who has-
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-
The submission of any adverse event report in compliance with this section shall not be construed as an admission that the nonprescription drug 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 nonprescription drugs, that is different from, in addition to, or otherwise not identical to, this section.
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-
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 379v of this title.
There are authorized to be appropriated to carry out this section such sums as may be necessary.
21 U.S.C. § 379aa
STATUTORY NOTES AND RELATED SUBSIDIARIES
EFFECTIVE DATESection effective 1 year after Dec. 22, 2006, see section 2(e)(1) of Pub. L. 109-462 set out as an Effective Date of 2006 Amendment note under section 352 of this title.
MODIFICATIONS Pub. L. 109-462, §2(b), Dec. 22, 2006, 120 Stat. 3472, provided that: "The Secretary of Health and Human Services may modify requirements under the amendments made by this section [enacting this section and amending sections 331 and 352 of this title] in accordance with section 553 of title 5, United States Code, to maintain consistency with international harmonization efforts over time."
GUIDANCE Pub. L. 109-462, §2(e)(3), Dec. 22, 2006, 120 Stat. 3472, provided that: "Not later than 270 days after the date of enactment of this Act [Dec. 22, 2006], the Secretary of Health and Human Services shall issue guidance on the minimum data elements that should be included in a serious adverse event report described under the amendments made by this Act [see Short Title of 2006 Amendment note set out under section 301 of this title]." Pub. L. 109-462, §3(d)(3), Dec. 22, 2006, 120 Stat. 3475, enacted provisions substantially identical to those enacted by Pub. L. 109-462, §2(e)(3), set out above.