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Title 21, Food and DrugsRelease 119-110

§379aa Serious Adverse Event Reporting for Nonprescription Drugs

Title 21 › CHAPTER 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT › SUBCHAPTER VII — GENERAL AUTHORITY › Part H — Serious Adverse Event Reports › § 379aa

Last updated Sep 22, 2026|Official source

Summary

Manufacturers, packers, or distributors whose name is on a nonprescription drug’s label must send the Secretary of Health and Human Services any report they get about a serious adverse event that happened in the United States. They must include a copy of the drug’s label. A retailer listed as a distributor can let the manufacturer or packer file the reports if the retailer forwards to them every adverse event reported to the retailer by the phone number or address on the package. Key terms: an adverse event is any bad health problem tied to using the drug (including overdose, abuse, withdrawal, or the drug not working); a nonprescription drug is a drug not covered by certain prescription or new-drug approval rules; a serious adverse event is one that causes death, is life‑threatening, needs hospital care, causes major disability, or causes a birth defect—or needs medical or surgical action to prevent those outcomes; a serious adverse event report is the report that must be sent. The responsible company must send the first report within 15 business days after it receives the report. If the company gets new medical information about that event within 1 year, it must send the new information within 15 business days. Reports must use the MedWatch form (which can be changed for nonprescription drugs). The Secretary will combine duplicate reports and may create exemptions after notice if there is no harm to public health. Companies must keep event records for 6 years and let authorized HHS staff inspect them. Reports are treated as safety reports and are protected by privacy rules; personal information must be removed before public release, and filing a report is not an admission that the drug caused the problem. States may not require different mandatory reporting systems, though the Secretary can share reports with state officials under agreement; shared personal data cannot be made public or re‑shared without consent. Funds may be provided as needed to run the program.

Full Legal Text

Title 21, §379aa

Food and Drugs, Source: USLM XML via OLRC

(a)Definitions
In this section: (1) Adverse event
(2)Nonprescription drug
The term “nonprescription drug” means a drug that is—
(A)not subject to section 353(b) of this title; and
(B)not subject to approval in an application submitted under section 355 of this title.
(3)Serious adverse event
The term “serious adverse event” is an adverse event that—
(A)results in—
(i)death;
(ii)a life-threatening experience;
(iii)inpatient hospitalization;
(iv)a persistent or significant disability or incapacity; or
(v)a congenital anomaly or birth defect; or
(B)requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described under subparagraph (A).
(4)Serious adverse event report
The term “serious adverse event report” means a report that is required to be submitted to the Secretary under subsection (b).
(b)Reporting requirement
(1)In general
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.
(2)Retailer
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.
(c)Submission of reports
(1)Timing of reports
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.
(2)New medical information
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.
(3)Consolidation of reports
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.
(4)Exemption
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.
(d)Contents of reports
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.
(e)Maintenance and inspection of records
(1)Maintenance
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.
(2)Records inspection
(A)In general
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.
(B)Authorized person
For purposes of this paragraph, the term “authorized person” means an officer or employee of the Department of Health and Human Services who has—
(i)appropriate credentials, as determined by the Secretary; and
(ii)been duly designated by the Secretary to have access to the records required under this section.
(f)Protected information
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—
(1)a safety report under section 379v of this title 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
(2)a record about an individual under section 552a of title 5 (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.
(g)Rule of construction
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.
(h)Preemption
(1)In general
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.
(2)Effect of section
(A)In general
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.
(B)Personally-identifiable information
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—
(i)be made publicly available pursuant to any State or other law requiring disclosure of information or records; or
(ii)otherwise be disclosed or distributed to any party without the written consent of the Secretary and the person submitting such information to the Secretary.
(C)Use of safety reports
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.
(i)Authorization of appropriations
There are authorized to be appropriated to carry out this section such sums as may be necessary.

Legislative History

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Effective Date

Section 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 section 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.

Reference

Citations & Metadata

Citation

21 U.S.C. § 379aa

Title 21, Food and Drugs

Last Updated

Sep 22, 2026

Release point: 119-110