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21 U.S.C. § 379aa — Serious adverse event reporting for nonprescription drugs
Federal law — U.S. Code and appendices · legal_authorities
**(a) Definitions** In this section:
(1) **Adverse event** — The term “adverse event” means any health-related event associated with the use of a nonprescription drug that is adverse, including—
(A) an event occurring from an overdose of the drug, whether accidental or intentional;
(B) an event occurring from abuse of the drug;
(C) an event occurring from withdrawal from the drug; and
(D) any failure of expected pharmacological action of the drug.
(2) **Nonprescription drug** — The term “nonprescription drug” means a drug that is—
(A) not subject to [section 353(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section353/b&num=0&edition=prelim); and
(B) not subject to approval in an application submitted under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim).
(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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section352/b/1&num=0&edition=preli
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Stable record: federal_law:legal_authorities:record_usc_f579d5491b0c888cca2979d4
Source file: Laws/federal/codes/united-states-code/title-21/section-379aa-serious-adverse-event-reporting-for-nonprescription-drugs--ceb27554fa.md
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Source location: Title 21, Chapter 9, § 379aa; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(a) Definitions** In this section:
(1) **Adverse event** — The term “adverse event” means any health-related event associated with the use of a nonprescription drug that is adverse, including—
(A) an event occurring from an overdose of the drug, whether accidental or intentional;
(B) an event occurring from abuse of the drug;
(C) an event occurring from withdrawal from the drug; and
(D) any failure of expected pharmacological action of the drug.
(2) **Nonprescription drug** — The term “nonprescription drug” means a drug that is—
(A) not subject to [section 353(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section353/b&num=0&edition=prelim); and
(B) not subject to approval in an application submitted under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim).
(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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section352/b/1&num=0&edition=prelim)) 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section352/x&num=0&edition=prelim).
**(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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section352/x&num=0&edition=prelim).
(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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section374&num=0&edition=prelim).
(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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section379v&num=0&edition=prelim) 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section552a&num=0&edition=prelim) (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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section379v&num=0&edition=prelim).
**(i) Authorization of appropriations** There are authorized to be appropriated to carry out this section such sums as may be necessary.
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Federal law — U.S. Code and appendices · legal_authorities
This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 301
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Necessity of effective approval of application** No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) is effective with respect to such drug.
**(b) Filing application; contents**
(1)
(A) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the application—
(i) full reports of investigations which have been made to show whether such drug is safe for use and whether such drug is effective in use;
(ii) a full list of the articles used as components of such drug;
(iii) a full statement of the composition of such drug;
(iv) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug;
(v) such samples of such drug and of the articles used as components thereof as the Secretary may require;
(vi) specimens of the labeling proposed to be used for such drug;
(vii) any assessments required under [section 355c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim); and
(viii) the patent number and expiration date of each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that—
(I) claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent; or
(II) claims a method of using such drug for which approv
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 355
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Definitions.—** For purposes of this section—
(1) the term “agency” means agency as defined in section 552(e) 11 See References in Text note below. of this title;
(2) the term “individual” means a citizen of the United States or an alien lawfully admitted for permanent residence;
(3) the term “maintain” includes maintain, collect, use, or disseminate;
(4) the term “record” means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, his education, financial transactions, medical history, and criminal or employment history and that contains his name, or the identifying number, symbol, or other identifying particular assigned to the individual, such as a finger or voice print or a photograph;
(5) the term “system of records” means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual;
(6) the term “statistical record” means a record in a system of records maintained for statistical research or reporting purposes only and not used in whole or in part in making any determination about an identifiable individual, except as provided by [section 8 of title 13](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title13-section8&num=0&edition=prelim);
(7) the term “routine use” means, with respect to the disclosure of a record, the use of such record for a purpose which is compatible with the purpose for which it was collected;
(8) the term “matching program”—
(A) means any computerized comparison of—
(i) two or more automated systems of records or a system of records with non-Federal records for the purpose
Source: Supplied U.S. Code snapshot — release unconfirmed · 5 U.S.C. § 552a
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Federal law — U.S. Code and appendices · legal_authorities
A drug or device shall be deemed to be misbranded—
**(a) False or misleading label**
(1) If its labeling is false or misleading in any particular. Health care economic information provided to a payor, formulary committee, or other similar entity with knowledge and expertise in the area of health care economic analysis, carrying out its responsibilities for the selection of drugs or devices for coverage or reimbursement, shall not be considered to be false or misleading under this paragraph if the health care economic information relates to an indication approved under section 355, 360(k), 360c(f)(2), or 360e of this title or [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim) for such drug or device, is based on competent and reliable scientific evidence, and includes, where applicable, a conspicuous and prominent statement describing any material differences between the health care economic information and the labeling approved for the drug or device under section 355, 360(k), 360c(f)(2), or 360e of this title or [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim). The requirements set forth in section 355, 360(k), 360c(f)(2), or 360e of this title or [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim) shall not apply to health care economic information provided to such a payor, committee, or entity in accordance with this paragraph. Information that is relevant to the substantiation of the health care economic information presented pursuant to this paragraph shall be made available to the Secretary upon request.
(2)
(A) For purposes of th
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 352
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Federal law — U.S. Code and appendices · legal_authorities
**(a)** This section applies, according to the provisions thereof, except to the extent that there is involved—
(1) a military or foreign affairs function of the United States; or
(2) a matter relating to agency management or personnel or to public property, loans, grants, benefits, or contracts.
**(b)** General notice of proposed rule making shall be published in the Federal Register, unless persons subject thereto are named and either personally served or otherwise have actual notice thereof in accordance with law. The notice shall include—
(1) a statement of the time, place, and nature of public rule making proceedings;
(2) reference to the legal authority under which the rule is proposed;
(3) either the terms or substance of the proposed rule or a description of the subjects and issues involved; and
(4) the Internet address of a summary of not more than 100 words in length of the proposed rule, in plain language, that shall be posted on the Internet website under section 206(d) of the E-Government Act of 2002 ([44 U.S.C. 3501](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title44-section3501&num=0&edition=prelim) note) (commonly known as regulations.gov).
Except when notice or hearing is required by statute, this subsection does not apply—
(A) to interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice; or
(B) when the agency for good cause finds (and incorporates the finding and a brief statement of reasons therefor in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.
**(c)** After notice required by this section, the agency shall give interested persons an opportunity to participate in the rule making through subm
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Right of agents to enter; scope of inspection; notice; promptness; exclusions**
(1) For purposes of enforcement of this chapter, officers or employees duly designated by the Secretary, upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge, are authorized (A) to enter, at reasonable times, any factory, warehouse, or establishment in which food, drugs, devices, tobacco products, or cosmetics are manufactured, processed, packed, or held, for introduction into interstate commerce or after such introduction, or to enter any vehicle being used to transport or hold such food, drugs, devices, tobacco products, or cosmetics in interstate commerce; and (B) to inspect, at reasonable times and within reasonable limits and in a reasonable manner, such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials, containers, and labeling therein. In the case of any person (excluding farms and restaurants) who manufactures, processes, packs, transports, distributes, holds, or imports foods, the inspection shall extend to all records and other information described in [section 350c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350c&num=0&edition=prelim), when the standard for records inspection under paragraph (1) or (2) of [section 350c(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350c/a&num=0&edition=prelim) applies, subject to the limitations established in [section 350c(d) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350c/d&num=0&edition=prelim). In the case of a facility (as defined in [section 364 of this title](https://uscode.house.gov/vi
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 374
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Federal law — U.S. Code and appendices · legal_authorities
With respect to any entity that submits or is required to submit a safety report or other information in connection with the safety of a product (including a product that is a food, drug, device, dietary supplement, or cosmetic) under this chapter (and any release by the Secretary of that report or information), such report or information shall not be construed to reflect necessarily a conclusion by the entity or the Secretary that the report or information constitutes an admission that the product involved malfunctioned, caused or contributed to an adverse experience, or otherwise caused or contributed to a death, serious injury, or serious illness. Such an entity need not admit, and may deny, that the report or information submitted by the entity constitutes an admission that the product involved malfunctioned, caused or contributed to an adverse experience, or caused or contributed to a death, serious injury, or serious illness.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 379v
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Performance report**
(1) **In general** — Not later than 120 calendar days after the end of each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 6502 of the Over-the-Counter Monograph Drug User Fee Amendments during such fiscal year and the future plans of the Food and Drug Administration for meeting such goals.
(2) **Additional information** — Beginning with fiscal year 2026, the annual report under this subsection shall include—
(A) the progress of the Food and Drug Administration in achieving the goals, and future plans for meeting the goals, including—
(i) the number of Tier 1 OTC monograph order requests for which a proposed order was issued, and the number of such requests for which a final order was issued, in the previous fiscal year;
(ii) the number of Tier 2 OTC monograph order requests for which a proposed order was issued, and the number of such requests for which a final order was issued, in the previous fiscal year;
(iii) the number of specified safety OTC monograph order requests for which a proposed order was issued, and the number of such requests for which a final order was issued, in the previous fiscal year;
(iv) the number of generally recognized as safe and effective finalization OTC monograph order requests for which a proposed order was issued, and the number of such requests for which a final order was issued, in the previous fiscal year;
(v) the average timeline for processing O
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 379j–73
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Federal law — U.S. Code and appendices · legal_authorities
Page 628
TITLE 21—FOOD AND DRUGS
§ 379s
§ 379s. Preemption for labeling or packaging of
cosmetics
(a) In general
Except as provided in subsection (b), (d), or (e),
no State or political subdivision of a State may
establish or continue in effect any requirement
for labeling or packaging of a cosmetic that is
different from or in addition to, or that is other-
wise not identical with, a requirement specifi-
cally applicable to a particular cosmetic or class
of cosmetics under this chapter, the Poison Pre-
vention Packaging Act of 1970 (15 U.S.C. 1471 et
seq.), or the Fair Packaging and Labeling Act
(15 U.S.C. 1451 et seq.).
(b) Exemption
Upon application of a State or political sub-
division thereof, the Secretary may by regula-
tion, after notice and opportunity for written
and oral presentation of views, exempt from sub-
section (a), under such conditions as may be pre-
scribed in such regulation, a State or political
subdivision requirement for labeling or pack-
aging that—
(1) protects an important public interest
that would otherwise be unprotected;
(2) would not cause a cosmetic to be in viola-
tion of any applicable requirement or prohibi-
tion under Federal law; and
(3) would not unduly burden interstate com-
merce.
(c) Scope
For purposes of subsection (a), a reference to
a State requirement that relates to the pack-
aging or labeling of a cosmetic means any spe-
cific requirement relating to the same aspect of
such cosmetic as a requirement specifically ap-
plicable to that particular cosmetic or class of
cosmetics under this chapter for packaging or
labeling, including any State requirement relat-
ing to public information or any other form of
public communication.
(d) No effect on product liability law
Nothing in this section shall be
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 379aa
Stored review status: historical_2024_not_currentness_verified. Same stored citation; legal effect and authority still require review.