---
kind: "section"
citation: "21 U.S.C. § 360bbb–3a"
title: "21"
title_heading: "Food and Drugs"
number: "360bbb–3a"
heading: "Emergency use of medical products"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/360bbb-3a"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part E — General Provisions Relating to Drugs and Devices"
---

# §360bbb–3a. Emergency use of medical products

- (a) **Definitions—** In this section:
  - (1) **Eligible product—** The term “eligible [product](/usc/21/360eee.md?p=13)” means a [product](/usc/21/360eee.md?p=13) that—
    - (A) is approved or cleared under this subchapter, conditionally approved under [section 360ccc of this title](/usc/21/360ccc.md), or [licensed](/usc/21/360eee.md?p=9) under section 351 of the Public Health Service Act [[42 U.S.C. 262](/usc/42/262.md)];
    - (B)
      - (i) is intended for use to prevent, diagnose, or treat a disease or condition involving a biological, chemical, radiological, or nuclear agent or agents; or
      - (ii) is intended for use to prevent, diagnose, or treat a serious or life-threatening disease or condition caused by a [product](/usc/21/360eee.md?p=13) described in [clause (i)](#a-1-B-i); and
    - (C) is intended for use during the circumstances under which—
      - (i) a determination described in subparagraph (A), (B), or (C) of [section 360bbb–3(b)(1) of this title](/usc/21/360bbb–3.md?p=b-1) has been made by the [Secretary](/usc/21/321.md?p=d) of Homeland Security, the [Secretary](/usc/21/321.md?p=d) of Defense, or the [Secretary](/usc/21/321.md?p=d), respectively; or
      - (ii) the identification of a material threat described in subparagraph (D) of [section 360bbb–3(b)(1) of this title](/usc/21/360bbb–3.md?p=b-1) has been made pursuant to section 319F–2 of the Public Health Service Act [[42 U.S.C. 247d–6b](/usc/42/247d–6b.md)].
  - (2) **Product—** The term “[product](/usc/21/360eee.md?p=13)” means a [drug](/usc/21/321.md?p=g-1), [device](/usc/21/321.md?p=h-1), or biological [product](/usc/21/360eee.md?p=13).
- (b) **Expiration dating—**
  - (1) **In general—** The [Secretary](/usc/21/321.md?p=d) may extend the expiration date and authorize the introduction or delivery for introduction into [interstate commerce](/usc/21/321.md?p=b) of an eligible [product](/usc/21/360eee.md?p=13) after the expiration date provided by the [manufacturer](/usc/21/360hh.md?p=3) if—
    - (A) the expiration date extension is intended to support the United States ability to protect—
      - (i) the public health; or
      - (ii) military preparedness and effectiveness; and
    - (B) the expiration date extension is supported by an appropriate scientific evaluation that is conducted or accepted by the [Secretary](/usc/21/321.md?p=d).
  - (2) **Requirements and conditions—** Any extension of an expiration date under [paragraph (1)](#b-1) shall, as part of the extension, identify—
    - (A) each specific lot, batch, or other unit of the [product](/usc/21/360eee.md?p=13) for which extended expiration is [authorized](/usc/21/360eee.md?p=2);
    - (B) the duration of the extension; and
    - (C) any other requirements or conditions as the [Secretary](/usc/21/321.md?p=d) may deem appropriate for the protection of the public health, which may include requirements for, or conditions on, [product](/usc/21/360eee.md?p=13) sampling, storage, packaging or repackaging, transport, [labeling](/usc/21/321.md?p=m), notice to [product](/usc/21/360eee.md?p=13) recipients, recordkeeping, periodic testing or retesting, or [product](/usc/21/360eee.md?p=13) [disposition](/usc/21/360eee.md?p=4).
  - (3) **Effect—** Notwithstanding any other provision of this chapter or the Public Health Service Act [[42 U.S.C. 201](/usc/42/201.md) et seq.], an eligible [product](/usc/21/360eee.md?p=13) shall not be considered an unapproved [product](/usc/21/360eee.md?p=13) (as defined in [section 360bbb–3(a)(2)(A) of this title](/usc/21/360bbb–3.md?p=a-2-A)) and shall not be deemed adulterated or misbranded under this chapter because, with respect to such [product](/usc/21/360eee.md?p=13), the [Secretary](/usc/21/321.md?p=d) has, under [paragraph (1)](#b-1), extended the expiration date and [authorized](/usc/21/360eee.md?p=2) the introduction or delivery for introduction into [interstate commerce](/usc/21/321.md?p=b) of such [product](/usc/21/360eee.md?p=13) after the expiration date provided by the [manufacturer](/usc/21/360hh.md?p=3).
  - (4) **Expiration date—** For purposes of this subsection, the term “expiration date” means the date established through appropriate stability testing required by the regulations issued by the [Secretary](/usc/21/321.md?p=d) to ensure that the [product](/usc/21/360eee.md?p=13) meets applicable standards of identity, strength, quality, and purity at the time of use.
- (c) **Current good manufacturing practice—**
  - (1) **In general—** The [Secretary](/usc/21/321.md?p=d) may, when the circumstances of a domestic, military, or public health emergency or material threat described in [subsection (a)(1)(C)](#a-1-C) so warrant, authorize, with respect to an eligible [product](/usc/21/360eee.md?p=13), deviations from current good manufacturing practice requirements otherwise applicable to the manufacture, processing, packing, or holding of [products](/usc/21/360eee.md?p=13) subject to regulation under this chapter, including requirements under section [351](/usc/21/351.md) or [360j(f)(1)](/usc/21/360j.md?p=f-1) of this title or applicable conditions prescribed with respect to the eligible [product](/usc/21/360eee.md?p=13) by an order under [section 360j(f)(2) of this title](/usc/21/360j.md?p=f-2).
  - (2) **Effect—** Notwithstanding any other provision of this chapter or the Public Health Service Act [[42 U.S.C. 201](/usc/42/201.md) et seq.], an eligible [product](/usc/21/360eee.md?p=13) shall not be considered an unapproved [product](/usc/21/360eee.md?p=13) (as defined in [section 360bbb–3(a)(2)(A) of this title](/usc/21/360bbb–3.md?p=a-2-A)) and shall not be deemed adulterated or misbranded under this chapter because, with respect to such [product](/usc/21/360eee.md?p=13), the [Secretary](/usc/21/321.md?p=d) has [authorized](/usc/21/360eee.md?p=2) deviations from current good manufacturing practices under [paragraph (1)](#c-1).
- (d) **Emergency dispensing—** The requirements of subsections [(b)](/usc/21/353.md?p=b) and [(f)](/usc/21/353.md?p=f) of section 353, [section 354](/usc/21/354.md), and [section 360j(e) of this title](/usc/21/360j.md?p=e) shall not apply to an eligible [product](/usc/21/360eee.md?p=13), and the [product](/usc/21/360eee.md?p=13) shall not be considered an unapproved [product](/usc/21/360eee.md?p=13) (as defined in [section 360bbb–3(a)(2)(A) of this title](/usc/21/360bbb–3.md?p=a-2-A)) and shall not be deemed adulterated or misbranded under this chapter because it is dispensed without an individual prescription, if—
  - (1) the [product](/usc/21/360eee.md?p=13) is dispensed during the circumstances described in [subsection (a)(1)(C)](#a-1-C); and
  - (2) such dispensing without an individual prescription occurs—
    - (A) as permitted under the law of the [State](/usc/21/321.md?p=a-1) in which the [product](/usc/21/360eee.md?p=13) is dispensed; or
    - (B) in accordance with an order issued by the [Secretary](/usc/21/321.md?p=d), for the purposes and duration of the circumstances described in [subsection (a)(1)(C)](#a-1-C).
- (e) **Emergency use instructions—**
  - (1) **In general—** The [Secretary](/usc/21/321.md?p=d), acting through an appropriate official within the [Department](/usc/21/321.md?p=c) of Health and Human Services, may create and issue emergency use instructions to inform health care providers or individuals to whom an eligible [product](/usc/21/360eee.md?p=13) is to be administered concerning such [product](/usc/21/360eee.md?p=13)’s approved, [licensed](/usc/21/360eee.md?p=9), or cleared conditions of use.
  - (2) **Effect—** Notwithstanding any other provisions of this chapter or the Public Health Service Act [[42 U.S.C. 201](/usc/42/201.md) et seq.], a [product](/usc/21/360eee.md?p=13) shall not be considered an unapproved [product](/usc/21/360eee.md?p=13) and shall not be deemed adulterated or misbranded under this chapter because of the issuance of emergency use instructions under [paragraph (1)](#e-1) with respect to such [product](/usc/21/360eee.md?p=13) or the introduction or delivery for introduction of such [product](/usc/21/360eee.md?p=13) into [interstate commerce](/usc/21/321.md?p=b) accompanied by such instructions—
    - (A) during an emergency response to an actual emergency that is the basis for a determination described in [subsection (a)(1)(C)](#a-1-C); or
    - (B) by a government entity (including a Federal, [State](/usc/21/321.md?p=a-1), local, or tribal government entity), or a [person](/usc/21/321.md?p=e) acting on behalf of such a government entity, in preparation for an emergency response.

## Source credit

(June 25, 1938, ch. 675, § 564A, as added Pub. L. 113–5, title III, § 302(b), Mar. 13, 2013, 127 Stat. 183; amended Pub. L. 114–255, div. A, title III, § 3088(c), Dec. 13, 2016, 130 Stat. 1149; Pub. L. 116–22, title VII, § 705(c), June 24, 2019, 133 Stat. 964.)

## Notes

### Editorial Notes

### References in Text

The Public Health Service Act, referred to in subsecs. (b)(3), (c)(2), and (e)(2), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§ 201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

### Amendments

2019—Subsec. (e)(2)(A). Pub. L. 116–22 substituted “subsection (a)(1)(C)” for “subsection (a)(1)(C)(i)”.

2016—Subsec. (a)(1)(A). Pub. L. 114–255, § 3088(c)(1), inserted “, conditionally approved under section 360ccc of this title,” after “subchapter”.

Subsec. (d). Pub. L. 114–255, § 3088(c)(2), substituted “subsections (b) and (f) of section 353, section 354, and section 360j(e) of this title” for “sections 353(b) and 360j(e) of this title” in introductory provisions.