---
kind: "section"
citation: "21 U.S.C. § 379aa"
title: "21"
title_heading: "Food and Drugs"
number: "379aa"
heading: "Serious adverse event reporting for nonprescription drugs"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/379aa"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter VII — General Authority"
  - "Part H — Serious Adverse Event Reports"
---

# §379aa. Serious adverse event reporting for nonprescription drugs

- (a) **Definitions—** In this section:
  - (1) **Adverse event—** The term “[adverse event](/usc/21/364.md?p=1)” means any health-related event associated with the use of a [nonprescription](/usc/21/360fff.md?p=5) [drug](/usc/21/321.md?p=g-1) that is adverse, including—
    - (A) an event occurring from an overdose of the [drug](/usc/21/321.md?p=g-1), whether accidental or intentional;
    - (B) an event occurring from abuse of the [drug](/usc/21/321.md?p=g-1);
    - (C) an event occurring from withdrawal from the [drug](/usc/21/321.md?p=g-1); and
    - (D) any failure of expected pharmacological action of the [drug](/usc/21/321.md?p=g-1).
  - (2) **Nonprescription drug—** The term “[nonprescription](/usc/21/360fff.md?p=5) [drug](/usc/21/321.md?p=g-1)” means a [drug](/usc/21/321.md?p=g-1) that is—
    - (A) not subject to [section 353(b) of this title](/usc/21/353.md?p=b); and
    - (B) not subject to approval in an application submitted under [section 355 of this title](/usc/21/355.md).
  - (3) **Serious adverse event—** The term “[serious adverse event](/usc/21/364.md?p=5)” is an [adverse event](/usc/21/364.md?p=1) 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)](#a-3-A).
  - (4) **Serious adverse event report—** The term “[serious adverse event](/usc/21/364.md?p=5) report” means a report that is required to be submitted to the [Secretary](/usc/21/321.md?p=d) under [subsection (b)](#b).
- (b) **Reporting requirement—**
  - (1) **In general—** The [manufacturer](/usc/21/360hh.md?p=3), packer, or distributor whose name (pursuant to [section 352(b)(1) of this title](/usc/21/352.md)) appears on the [label](/usc/21/321.md?p=k) of a [nonprescription](/usc/21/360fff.md?p=5) [drug](/usc/21/321.md?p=g-1) marketed in the United States (referred to in this section as the “[responsible person](/usc/21/364.md?p=4)”) shall submit to the [Secretary](/usc/21/321.md?p=d) any report received of a [serious adverse event](/usc/21/364.md?p=5) associated with such [drug](/usc/21/321.md?p=g-1) when used in the United States, accompanied by a copy of the [label](/usc/21/321.md?p=k) on or within the retail [package](/usc/21/360eee.md?p=11-A) of such [drug](/usc/21/321.md?p=g-1).
  - (2) **Retailer—** A retailer whose name appears on the [label](/usc/21/321.md?p=k) described in [paragraph (1)](#b-1) as a distributor may, by agreement, authorize the [manufacturer](/usc/21/360hh.md?p=3) or packer of the [nonprescription](/usc/21/360fff.md?p=5) [drug](/usc/21/321.md?p=g-1) to submit the required reports for such [drugs](/usc/21/321.md?p=g-1) to the [Secretary](/usc/21/321.md?p=d) so long as the retailer directs to the [manufacturer](/usc/21/360hh.md?p=3) or packer all [adverse events](/usc/21/364.md?p=1) associated with such [drug](/usc/21/321.md?p=g-1) that are reported to the retailer through the address or telephone number described in [section 352(x) of this title](/usc/21/352.md?p=x).
- (c) **Submission of reports—**
  - (1) **Timing of reports—** The [responsible person](/usc/21/364.md?p=4) shall submit to the [Secretary](/usc/21/321.md?p=d) a [serious adverse event](/usc/21/364.md?p=5) 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](/usc/21/352.md?p=x).
  - (2) **New medical information—** The [responsible person](/usc/21/364.md?p=4) shall submit to the [Secretary](/usc/21/321.md?p=d) any new medical information, related to a submitted [serious adverse event](/usc/21/364.md?p=5) report that is received by the [responsible person](/usc/21/364.md?p=4) within 1 year of the initial report, no later than 15 business days after the new information is received by the [responsible person](/usc/21/364.md?p=4).
  - (3) **Consolidation of reports—** The [Secretary](/usc/21/321.md?p=d) shall develop systems to ensure that duplicate reports of, and new medical information related to, a [serious adverse event](/usc/21/364.md?p=5) shall be consolidated into a single report.
  - (4) **Exemption—** The [Secretary](/usc/21/321.md?p=d), after providing notice and an opportunity for comment from interested parties, may establish an exemption to the requirements under paragraphs [(1)](#c-1) and [(2)](#c-2) if the [Secretary](/usc/21/321.md?p=d) determines that such exemption would have no adverse effect on public health.
- (d) **Contents of reports—** Each [serious adverse event](/usc/21/364.md?p=5) report under this section shall be submitted to the [Secretary](/usc/21/321.md?p=d) using the MedWatch form, which may be modified by the [Secretary](/usc/21/321.md?p=d) for [nonprescription](/usc/21/360fff.md?p=5) [drugs](/usc/21/321.md?p=g-1), and may be accompanied by additional information.
- (e) **Maintenance and inspection of records—**
  - (1) **Maintenance—** The [responsible person](/usc/21/364.md?p=4) shall maintain records related to each report of an [adverse event](/usc/21/364.md?p=1) received by the [responsible person](/usc/21/364.md?p=4) for a period of 6 years.
  - (2) **Records inspection—**
    - (A) **In general—** The [responsible person](/usc/21/364.md?p=4) shall permit an [authorized](/usc/21/360eee.md?p=2) [person](/usc/21/321.md?p=e) to have access to records required to be maintained under this section, during an inspection pursuant to [section 374 of this title](/usc/21/374.md).
    - (B) **Authorized person—** For purposes of this paragraph, the term “[authorized](/usc/21/360eee.md?p=2) [person](/usc/21/321.md?p=e)” means an officer or employee of the [Department](/usc/21/321.md?p=c) of Health and Human Services who has—
      - (i) appropriate credentials, as determined by the [Secretary](/usc/21/321.md?p=d); and
      - (ii) been duly designated by the [Secretary](/usc/21/321.md?p=d) to have access to the records required under this section.
- (f) **Protected information—** A [serious adverse event](/usc/21/364.md?p=5) report submitted to the [Secretary](/usc/21/321.md?p=d) under this section, including any new medical information submitted under [subsection (c)(2)](#c-2), or an [adverse event](/usc/21/364.md?p=1) report voluntarily submitted to the [Secretary](/usc/21/321.md?p=d) shall be considered to be—
  - (1) a safety report under [section 379v of this title](/usc/21/379v.md) 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](/usc/21/360eee.md?p=13) involved caused or contributed to the [adverse event](/usc/21/364.md?p=1); and
  - (2) a record about an individual under [section 552a of title 5](/usc/5/552a.md) (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](/usc/5/552.md) of such [title 5](/usc/5.md) (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](/usc/21/364.md?p=1) report in compliance with this section shall not be construed as an admission that the [nonprescription](/usc/21/360fff.md?p=5) [drug](/usc/21/321.md?p=g-1) involved caused or contributed to the [adverse event](/usc/21/364.md?p=1).
- (h) **Preemption—**
  - (1) **In general—** No [State](/usc/21/321.md?p=a-1) or local government shall establish or continue in effect any law, regulation, order, or other requirement, related to a mandatory system for [adverse event](/usc/21/364.md?p=1) reports for [nonprescription](/usc/21/360fff.md?p=5) [drugs](/usc/21/321.md?p=g-1), 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](/usc/21/321.md?p=d) to provide [adverse event](/usc/21/364.md?p=1) reports and information to any health, [food](/usc/21/321.md?p=f), or [drug](/usc/21/321.md?p=g-1) officer or employee of any [State](/usc/21/321.md?p=a-1), [territory](/usc/21/321.md?p=a-2), or political subdivision of a [State](/usc/21/321.md?p=a-1) or [territory](/usc/21/321.md?p=a-2), under a memorandum of understanding between the [Secretary](/usc/21/321.md?p=d) and such [State](/usc/21/321.md?p=a-1), [territory](/usc/21/321.md?p=a-2), or political subdivision.
    - (B) **Personally-identifiable information—** Notwithstanding any other provision of law, personally-identifiable information in [adverse event](/usc/21/364.md?p=1) reports provided by the [Secretary](/usc/21/321.md?p=d) to any health, [food](/usc/21/321.md?p=f), or [drug](/usc/21/321.md?p=g-1) officer or employee of any [State](/usc/21/321.md?p=a-1), [territory](/usc/21/321.md?p=a-2), or political subdivision of a [State](/usc/21/321.md?p=a-1) or [territory](/usc/21/321.md?p=a-2), shall not—
      - (i) be made publicly available pursuant to any [State](/usc/21/321.md?p=a-1) 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](/usc/21/321.md?p=d) and the [person](/usc/21/321.md?p=e) submitting such information to the [Secretary](/usc/21/321.md?p=d).
    - (C) **Use of safety reports—** Nothing in this section shall permit a [State](/usc/21/321.md?p=a-1), [territory](/usc/21/321.md?p=a-2), or political subdivision of a [State](/usc/21/321.md?p=a-1) or [territory](/usc/21/321.md?p=a-2), to use any safety report received from the [Secretary](/usc/21/321.md?p=d) in a manner inconsistent with [subsection (g)](#g) or [section 379v of this title](/usc/21/379v.md).
- (i) **Authorization of appropriations—** There are [authorized](/usc/21/360eee.md?p=2) to be appropriated to carry out this section such sums as may be necessary.

## Source credit

(June 25, 1938, ch. 675, § 760, as added Pub. L. 109–462, § 2(a), Dec. 22, 2006, 120 Stat. 3469.)

## Notes

### 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 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.