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

# §360bbb–3. Authorization for medical products for use in emergencies

- (a) **In general—**
  - (1) **Emergency uses—** Notwithstanding any provision of this chapter and section 351 of the Public Health Service Act [[42 U.S.C. 262](/usc/42/262.md)], and subject to the provisions of this section, the [Secretary](/usc/21/321.md?p=d) may authorize the introduction into [interstate commerce](/usc/21/321.md?p=b), during the effective period of a declaration under [subsection (b)](#b), of 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) intended for use in an actual or potential emergency (referred to in this section as an “emergency use”).
  - (2) **Approval status of product—** An authorization under [paragraph (1)](#a-1) may authorize an emergency use of a [product](/usc/21/360eee.md?p=13) that—
    - (A) is not approved, [licensed](/usc/21/360eee.md?p=9), or cleared for commercial [distribution](/usc/21/360eee.md?p=5) under section [355](/usc/21/355.md), [360(k)](/usc/21/360.md?p=k), [360b](/usc/21/360b.md), or [360e](/usc/21/360e.md) of this title or section 351 of the Public Health Service Act [[42 U.S.C. 262](/usc/42/262.md)] or conditionally approved under [section 360ccc of this title](/usc/21/360ccc.md) (referred to in this section as an “unapproved [product](/usc/21/360eee.md?p=13)”); or
    - (B) is approved, conditionally approved under [section 360ccc of this title](/usc/21/360ccc.md), [licensed](/usc/21/360eee.md?p=9), or cleared under such a provision, but which use is not under such provision an approved, conditionally approved under [section 360ccc of this title](/usc/21/360ccc.md), [licensed](/usc/21/360eee.md?p=9), or cleared use of the [product](/usc/21/360eee.md?p=13) (referred to in this section as an “unapproved use of an approved [product](/usc/21/360eee.md?p=13)”).
  - (3) **Relation to other uses—** An emergency use [authorized](/usc/21/360eee.md?p=2) under [paragraph (1)](#a-1) for a [product](/usc/21/360eee.md?p=13) is in addition to any other use that is [authorized](/usc/21/360eee.md?p=2) for the [product](/usc/21/360eee.md?p=13) under a section of this chapter or the Public Health Service Act [[42 U.S.C. 201](/usc/42/201.md) et seq.] referred to in [paragraph (2)(A)](#a-2-A).
  - (4) **Definitions—** For purposes of this section:
    - (A) The term “biological [product](/usc/21/360eee.md?p=13)” has the meaning given such term in section 351 of the Public Health Service Act [[42 U.S.C. 262](/usc/42/262.md)].
    - (B) The term “emergency use” has the meaning indicated for such term in [paragraph (1)](#a-1).
    - (C) 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).
    - (D) The term “unapproved [product](/usc/21/360eee.md?p=13)” has the meaning indicated for such term in [paragraph (2)(A)](#a-2-A).
    - (E) The term “unapproved use of an approved [product](/usc/21/360eee.md?p=13)” has the meaning indicated for such term in [paragraph (2)(B)](#a-2-B).
- (b) **Declaration of emergency or threat justifying emergency authorized use—**
  - (1) **In general—** The [Secretary](/usc/21/321.md?p=d) may make a declaration that the circumstances exist justifying the authorization under this subsection for a [product](/usc/21/360eee.md?p=13) on the basis of—
    - (A) a determination by the [Secretary](/usc/21/321.md?p=d) of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent or agents;
    - (B) a determination by the [Secretary](/usc/21/321.md?p=d) of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States military forces, including personnel operating under the authority of [title 10](/usc/10.md) or [title 50](/usc/50.md), of attack with—
      - (i) a biological, chemical, radiological, or nuclear agent or agents; or
      - (ii) an agent or agents that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to United States military forces;
    - (C) a determination by the [Secretary](/usc/21/321.md?p=d) that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad, and that involves a biological, chemical, radiological, or nuclear agent or agents, or a disease or condition that may be attributable to such agent or agents; or
    - (D) the identification of a material threat pursuant to section 319F–2 of the Public Health Service Act [[42 U.S.C. 247d–6b](/usc/42/247d–6b.md)] sufficient to affect national security or the health and security of United States citizens living abroad.
  - (2) **Termination of declaration—**
    - (A) **In general—** A declaration under this subsection shall terminate upon the earlier of—
      - (i) a determination by the [Secretary](/usc/21/321.md?p=d), in consultation as appropriate with the [Secretary](/usc/21/321.md?p=d) of Homeland Security or the [Secretary](/usc/21/321.md?p=d) of Defense, that the circumstances described in [paragraph (1)](#b-1) have ceased to exist; or
      - (ii) a change in the approval status of the [product](/usc/21/360eee.md?p=13) such that the circumstances described in [subsection (a)(2)](#a-2) have ceased to exist.
    - (B) **Disposition of product—** If an authorization under this section with respect to an unapproved [product](/usc/21/360eee.md?p=13) ceases to be effective as a result of a termination under subparagraph (A) of this paragraph, the [Secretary](/usc/21/321.md?p=d) shall consult with the [manufacturer](/usc/21/360hh.md?p=3) of such [product](/usc/21/360eee.md?p=13) with respect to the appropriate [disposition](/usc/21/360eee.md?p=4) of the [product](/usc/21/360eee.md?p=13).
  - (3) **Advance notice of termination—** The [Secretary](/usc/21/321.md?p=d) shall provide advance notice that a declaration under this subsection will be terminated. The period of advance notice shall be a period reasonably determined to provide—
    - (A) in the case of an unapproved [product](/usc/21/360eee.md?p=13), a sufficient period for [disposition](/usc/21/360eee.md?p=4) of the [product](/usc/21/360eee.md?p=13), including the [return](/usc/21/360eee.md?p=17) of such [product](/usc/21/360eee.md?p=13) (except such quantities of [product](/usc/21/360eee.md?p=13) as are necessary to provide for continued use consistent with [subsection (f)(2)](#f-2)) to the [manufacturer](/usc/21/360hh.md?p=3) (in the case of a [manufacturer](/usc/21/360hh.md?p=3) that chooses to have such [product](/usc/21/360eee.md?p=13) returned); and
    - (B) in the case of an unapproved use of an approved [product](/usc/21/360eee.md?p=13), a sufficient period for the [disposition](/usc/21/360eee.md?p=4) of any [labeling](/usc/21/321.md?p=m), or any information under [subsection (e)(2)(B)(ii)](#e-2-B-ii), as the case may be, that was provided with respect to the emergency use involved.
  - (4) **Publication—** The [Secretary](/usc/21/321.md?p=d) shall promptly publish in the Federal Register each declaration, determination, and advance notice of termination under this subsection.
  - (5) **Explanation by Secretary—** If an authorization under this section with respect to an unapproved [product](/usc/21/360eee.md?p=13) or an unapproved use of an approved [product](/usc/21/360eee.md?p=13) has been in effect for more than 1 year, the [Secretary](/usc/21/321.md?p=d) shall provide in writing to the [sponsor](/usc/21/360fff.md?p=8) of such [product](/usc/21/360eee.md?p=13) an explanation of the scientific, regulatory, or other obstacles to approval, licensure, or clearance of such [product](/usc/21/360eee.md?p=13) or use, including specific actions to be taken by the [Secretary](/usc/21/321.md?p=d) and the [sponsor](/usc/21/360fff.md?p=8) to overcome such obstacles.
  - (6) **Military emergencies—** In the case of a determination described in [paragraph (1)(B)](#b-1-B), the [Secretary](/usc/21/321.md?p=d) shall determine, within 45 calendar days of such determination, whether to make a declaration under [paragraph (1)](#b-1), and, if appropriate, shall promptly make such a declaration.
- (c) **Criteria for issuance of authorization—** The [Secretary](/usc/21/321.md?p=d) may issue an authorization under this section with respect to the emergency use of a [product](/usc/21/360eee.md?p=13) only if, after consultation with the Assistant [Secretary](/usc/21/321.md?p=d) for Preparedness and Response, the Director of the National Institutes of Health, and the Director of the Centers for Disease Control and Prevention (to the extent feasible and appropriate given the applicable circumstances described in [subsection (b)(1)](#b-1)), the [Secretary](/usc/21/321.md?p=d) concludes—
  - (1) that an agent referred to in a declaration under [subsection (b)](#b) can cause a serious or life-threatening disease or condition;
  - (2) that, based on the totality of scientific evidence available to the [Secretary](/usc/21/321.md?p=d), including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that—
    - (A) the [product](/usc/21/360eee.md?p=13) may be effective in diagnosing, treating, or preventing—
      - (i) such disease or condition; or
      - (ii) a serious or life-threatening disease or condition caused by a [product](/usc/21/360eee.md?p=13) [authorized](/usc/21/360eee.md?p=2) under this section, approved or cleared under this chapter, 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)], for diagnosing, treating, or preventing such a disease or condition caused by such an agent; and
    - (B) the known and potential benefits of the [product](/usc/21/360eee.md?p=13), when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the [product](/usc/21/360eee.md?p=13), taking into consideration the material threat posed by the agent or agents identified in a declaration under [subsection (b)(1)(D)](#b-1-D), if applicable;
  - (3) that there is no adequate, approved, and available alternative to the [product](/usc/21/360eee.md?p=13) for diagnosing, preventing, or treating such disease or condition;
  - (4) in the case of a determination described in [subsection (b)(1)(B)(ii)](#b-1-B-ii), that the request for emergency use is made by the [Secretary](/usc/21/321.md?p=d) of Defense; and
  - (5) that such other criteria as the [Secretary](/usc/21/321.md?p=d) may by regulation prescribe are satisfied.
- (d) **Scope of authorization—** An authorization of a [product](/usc/21/360eee.md?p=13) under this section shall [state](/usc/21/321.md?p=a-1)—
  - (1) each disease or condition that the [product](/usc/21/360eee.md?p=13) may be used to diagnose, prevent, or treat within the scope of the authorization;
  - (2) the [Secretary](/usc/21/321.md?p=d)’s conclusions, made under [subsection (c)(2)(B)](#c-2-B), that the known and potential benefits of the [product](/usc/21/360eee.md?p=13), when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the [product](/usc/21/360eee.md?p=13); and
  - (3) the [Secretary](/usc/21/321.md?p=d)’s conclusions, made under [subsection (c)](#c), concerning the safety and potential effectiveness of the [product](/usc/21/360eee.md?p=13) in diagnosing, preventing, or treating such diseases or conditions, including, to the extent practicable given the circumstances of the emergency, an assessment of the available scientific evidence.
- (e) **Conditions of authorization—**
  - (1) **Unapproved product—**
    - (A) **Required conditions—** With respect to the emergency use of an unapproved [product](/usc/21/360eee.md?p=13), the [Secretary](/usc/21/321.md?p=d), to the extent practicable given the applicable circumstances described in [subsection (b)(1)](#b-1), shall, for a [person](/usc/21/321.md?p=e) who carries out any activity for which the authorization is issued, establish such conditions on an authorization under this section as the [Secretary](/usc/21/321.md?p=d) finds necessary or appropriate to protect the public health, including the following:
      - (i) Appropriate conditions designed to ensure that health care professionals administering the [product](/usc/21/360eee.md?p=13) are informed—
        - (I) that the [Secretary](/usc/21/321.md?p=d) has [authorized](/usc/21/360eee.md?p=2) the emergency use of the [product](/usc/21/360eee.md?p=13);
        - (II) of the significant known and potential benefits and risks of the emergency use of the [product](/usc/21/360eee.md?p=13), and of the extent to which such benefits and risks are unknown; and
        - (III) of the alternatives to the [product](/usc/21/360eee.md?p=13) that are available, and of their benefits and risks.
      - (ii) Appropriate conditions designed to ensure that individuals to whom the [product](/usc/21/360eee.md?p=13) is administered are informed—
        - (I) that the [Secretary](/usc/21/321.md?p=d) has [authorized](/usc/21/360eee.md?p=2) the emergency use of the [product](/usc/21/360eee.md?p=13);
        - (II) of the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown; and
        - (III) of the option to accept or refuse administration of the [product](/usc/21/360eee.md?p=13), of the consequences, if any, of refusing administration of the [product](/usc/21/360eee.md?p=13), and of the alternatives to the [product](/usc/21/360eee.md?p=13) that are available and of their benefits and risks.
      - (iii) Appropriate conditions for the monitoring and reporting of adverse events associated with the emergency use of the [product](/usc/21/360eee.md?p=13).
      - (iv) For [manufacturers](/usc/21/360hh.md?p=3) of the [product](/usc/21/360eee.md?p=13), appropriate conditions concerning recordkeeping and reporting, including records access by the [Secretary](/usc/21/321.md?p=d), with respect to the emergency use of the [product](/usc/21/360eee.md?p=13).
    - (B) **Authority for additional conditions—** With respect to the emergency use of an unapproved [product](/usc/21/360eee.md?p=13), the [Secretary](/usc/21/321.md?p=d) may, for a [person](/usc/21/321.md?p=e) who carries out any activity for which the authorization is issued, establish such conditions on an authorization under this section as the [Secretary](/usc/21/321.md?p=d) finds necessary or appropriate to protect the public health, including the following:
      - (i) Appropriate conditions on which entities may [distribute](/usc/21/360eee.md?p=5) the [product](/usc/21/360eee.md?p=13) with respect to the emergency use of the [product](/usc/21/360eee.md?p=13) (including limitation to [distribution](/usc/21/360eee.md?p=5) by government entities), and on how [distribution](/usc/21/360eee.md?p=5) is to be performed.
      - (ii) Appropriate conditions on who may administer the [product](/usc/21/360eee.md?p=13) with respect to the emergency use of the [product](/usc/21/360eee.md?p=13), and on the categories of individuals to whom, and the circumstances under which, the [product](/usc/21/360eee.md?p=13) may be administered with respect to such use.
      - (iii) Appropriate conditions with respect to collection and analysis of information concerning the safety and effectiveness of the [product](/usc/21/360eee.md?p=13) with respect to the use of such [product](/usc/21/360eee.md?p=13) during the period when the authorization is in effect and a reasonable time following such period.
      - (iv) For [persons](/usc/21/321.md?p=e) other than [manufacturers](/usc/21/360hh.md?p=3) of the [product](/usc/21/360eee.md?p=13), appropriate conditions concerning recordkeeping and reporting, including records access by the [Secretary](/usc/21/321.md?p=d), with respect to the emergency use of the [product](/usc/21/360eee.md?p=13).
  - (2) **Unapproved use—** With respect to the emergency use of a [product](/usc/21/360eee.md?p=13) that is an unapproved use of an approved [product](/usc/21/360eee.md?p=13):
    - (A) For a [person](/usc/21/321.md?p=e) who carries out any activity for which the authorization is issued, the [Secretary](/usc/21/321.md?p=d) shall, to the extent practicable given the applicable circumstances described in [subsection (b)(1)](#b-1), establish conditions described in clauses [(i)](#e-1-A-i) and [(ii)](#e-1-A-ii) of paragraph (1)(A), and may establish conditions described in clauses [(iii)](#e-1-A-iii) and [(iv)](#e-1-A-iv) of such paragraph or in [paragraph (1)(B)](#e-1-B).
    - (B)
      - (i) If the authorization under this section regarding the emergency use authorizes a change in the [labeling](/usc/21/321.md?p=m) of the [product](/usc/21/360eee.md?p=13), but the [manufacturer](/usc/21/360hh.md?p=3) of the [product](/usc/21/360eee.md?p=13) chooses not to make such change, such authorization may not authorize distributors of the [product](/usc/21/360eee.md?p=13) or any other [person](/usc/21/321.md?p=e) to alter or obscure the [labeling](/usc/21/321.md?p=m) provided by the [manufacturer](/usc/21/360hh.md?p=3), except as provided in [section 360bbb–3a of this title](/usc/21/360bbb–3a.md) with respect to [authorized](/usc/21/360eee.md?p=2) changes to the [product](/usc/21/360eee.md?p=13) expiration date.
      - (ii) In the circumstances described in [clause (i)](#e-2-B-i), for a [person](/usc/21/321.md?p=e) who does not manufacture the [product](/usc/21/360eee.md?p=13) and who chooses to act under this clause, an authorization under this section regarding the emergency use shall, to the extent practicable given the circumstances of the emergency, authorize such [person](/usc/21/321.md?p=e) to provide appropriate information with respect to such [product](/usc/21/360eee.md?p=13) in addition to the [labeling](/usc/21/321.md?p=m) provided by the [manufacturer](/usc/21/360hh.md?p=3), subject to compliance with [clause (i)](#e-2-B-i). While the authorization under this section is effective, such additional information shall not be considered [labeling](/usc/21/321.md?p=m) for purposes of [section 352 of this title](/usc/21/352.md).
    - (C) In establishing conditions under this paragraph with respect to the [distribution](/usc/21/360eee.md?p=5) and administration of the [product](/usc/21/360eee.md?p=13) for the unapproved use, the [Secretary](/usc/21/321.md?p=d) shall not impose conditions that would restrict [distribution](/usc/21/360eee.md?p=5) or administration of the [product](/usc/21/360eee.md?p=13) when distributed or administered for the approved use.
  - (3) **Good manufacturing practice; prescription—** With respect to the emergency use of a [product](/usc/21/360eee.md?p=13) for which an authorization under this section is issued (whether an unapproved [product](/usc/21/360eee.md?p=13) or an unapproved use of an approved [product](/usc/21/360eee.md?p=13)), the [Secretary](/usc/21/321.md?p=d) may waive or limit, to the extent appropriate given the applicable circumstances described in [subsection (b)(1)](#b-1)—
    - (A) requirements regarding current good manufacturing practice otherwise applicable to the manufacture, processing, packing, or holding of [products](/usc/21/360eee.md?p=13) subject to regulation under this chapter, including such requirements established under section [351](/usc/21/351.md) or [360j(f)(1)](/usc/21/360j.md?p=f-1) of this title, and including relevant conditions prescribed with respect to the [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);
    - (B) requirements established under subsection (b) or (f) of [section 353 of this title](/usc/21/353.md) or under [section 354 of this title](/usc/21/354.md); and
    - (C) requirements established under [section 360j(e) of this title](/usc/21/360j.md?p=e).
  - (4) **Advertising—** The [Secretary](/usc/21/321.md?p=d) may establish conditions on advertisements and other promotional descriptive printed matter that relate to the emergency use of a [product](/usc/21/360eee.md?p=13) for which an authorization under this section is issued (whether an unapproved [product](/usc/21/360eee.md?p=13) or an unapproved use of an approved [product](/usc/21/360eee.md?p=13)), including, as appropriate—
    - (A) with respect to [drugs](/usc/21/321.md?p=g-1) and biological [products](/usc/21/360eee.md?p=13), requirements applicable to [prescription drugs](/usc/21/360eee.md?p=12) pursuant to [section 352(n) of this title](/usc/21/352.md?p=n); or
    - (B) with respect to [devices](/usc/21/321.md?p=h-1), requirements applicable to restricted [devices](/usc/21/321.md?p=h-1) pursuant to [section 352(r) of this title](/usc/21/352.md?p=r).
- (f) **Duration of authorization—**
  - (1) **In general—** Except as provided in [paragraph (2)](#f-2), an authorization under this section shall be effective until the earlier of the termination of the declaration under [subsection (b)](#b) or a revocation under [subsection (g)](#g).
  - (2) **Continued use after end of effective period—** Notwithstanding the termination of the declaration under [subsection (b)](#b) or a revocation under [subsection (g)](#g), an authorization shall continue to be effective to provide for continued use of an unapproved [product](/usc/21/360eee.md?p=13) with respect to a patient to whom, or an animal to which, it was administered during the period described by [paragraph (1)](#f-1), to the extent found necessary by such patient’s attending physician or by the veterinarian caring for such animal, as applicable.
- (g) **Review and revocation of authorization—**
  - (1) **Review—** The [Secretary](/usc/21/321.md?p=d) shall periodically review the circumstances and the appropriateness of an authorization under this section. As part of such review, the [Secretary](/usc/21/321.md?p=d) shall regularly review the progress made with respect to the approval, conditional approval under [section 360ccc of this title](/usc/21/360ccc.md), licensure, or clearance of—
    - (A) an unapproved [product](/usc/21/360eee.md?p=13) for which an authorization was issued under this section; or
    - (B) an unapproved use of an approved [product](/usc/21/360eee.md?p=13) for which an authorization was issued under this section.
  - (2) **Revision and revocation—** The [Secretary](/usc/21/321.md?p=d) may revise or revoke an authorization under this section if—
    - (A) the circumstances described under [subsection (b)(1)](#b-1) no longer exist;
    - (B) the criteria under [subsection (c)](#c) for issuance of such authorization are no longer met; or
    - (C) other circumstances make such revision or revocation appropriate to protect the public health or safety.
- (h) **Publication; confidential information—**
  - (1) **Publication—** The [Secretary](/usc/21/321.md?p=d) shall promptly publish on the internet website of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration and in the Federal Register a notice of each authorization, and each termination or revocation of an authorization under this section, and an explanation of the reasons therefor (which may include a summary of data or information that has been submitted to the [Secretary](/usc/21/321.md?p=d) in an application, request, or submission under this section or section [355(b)](/usc/21/355.md?p=b), [355(i)](/usc/21/355.md?p=i), [355(j)](/usc/21/355.md?p=j), [360b(b)](/usc/21/360b.md?p=b), [360b(j)](/usc/21/360b.md?p=j), [360b(n)](/usc/21/360b.md?p=n), [360e](/usc/21/360e.md), [360(k)](/usc/21/360.md?p=k), [360c(f)(2)](/usc/21/360c.md?p=f-2), [360j(g)](/usc/21/360j.md?p=g), [360j(m)](/usc/21/360j.md?p=m), [360ccc](/usc/21/360ccc.md), or [360ccc–1](/usc/21/360ccc–1.md) of this title, or section 351(a) or 351(k) of the Public Health Service Act [[42 U.S.C. 262(a)](/usc/42/262.md?p=a), (k)], even if such summary may reveal the existence of such an application, request, or submission, or data contained in such application, request, or submission). The [Secretary](/usc/21/321.md?p=d) shall make any revisions to an authorization under this section available on the Internet Web site of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration, which may include a summary of the data and information supporting such revisions.
  - (2) **Confidential information—** Nothing in this section alters or amends [section 1905 of title 18](/usc/18/1905.md) or [section 552(b)(4) of title 5](/usc/5/552.md?p=b-4). Information made publicly available by the [Secretary](/usc/21/321.md?p=d) in accordance with [paragraph (1)](#h-1) shall be considered a disclosure [authorized](/usc/21/360eee.md?p=2) by law for purposes of [section 1905 of title 18](/usc/18/1905.md)[^1]
- (i) **Actions committed to agency discretion—** Actions under the authority of this section by the [Secretary](/usc/21/321.md?p=d), by the [Secretary](/usc/21/321.md?p=d) of Defense, or by the [Secretary](/usc/21/321.md?p=d) of Homeland Security are committed to agency discretion.
- (j) **Rules of construction—** The following applies with respect to this section:
  - (1) Nothing in this section impairs the authority of the President as Commander in Chief of the Armed Forces of the United States under article II, section 2 of the United States Constitution.
  - (2) Nothing in this section impairs the authority of the [Secretary](/usc/21/321.md?p=d) of Defense with respect to the [Department](/usc/21/321.md?p=c) of Defense, including the armed forces, under other provisions of Federal law.
  - (3) Nothing in this section (including any exercise of authority by a [manufacturer](/usc/21/360hh.md?p=3) under [subsection (e)(2)](#e-2)) impairs the authority of the United States to use or manage quantities of a [product](/usc/21/360eee.md?p=13) that are owned or controlled by the United States (including quantities in the stockpile maintained under section 319F–2 of the Public Health Service Act [[42 U.S.C. 247d–6b](/usc/42/247d–6b.md)]).
  - (4) Nothing in this section shall be construed as authorizing a delay in the review or other consideration by the [Secretary](/usc/21/321.md?p=d) of any application or submission pending before the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration for a [product](/usc/21/360eee.md?p=13) for which an authorization under this section is issued.
- (k) **Relation to other provisions—** If a [product](/usc/21/360eee.md?p=13) is the subject of an authorization under this section, the use of such [product](/usc/21/360eee.md?p=13) within the scope of the authorization shall not be considered to constitute a clinical investigation for purposes of section [355(i)](/usc/21/355.md?p=i), [360b(j)](/usc/21/360b.md?p=j), or [360j(g)](/usc/21/360j.md?p=g) of this title or any other provision of this chapter or section 351 of the Public Health Service Act [[42 U.S.C. 262](/usc/42/262.md)].
- (l) **Option to carry out authorized activities—** Nothing in this section provides the [Secretary](/usc/21/321.md?p=d) any authority to require any [person](/usc/21/321.md?p=e) to carry out any activity that becomes lawful pursuant to an authorization under this section, and no [person](/usc/21/321.md?p=e) is required to inform the [Secretary](/usc/21/321.md?p=d) that the [person](/usc/21/321.md?p=e) will not be carrying out such activity, except that a [manufacturer](/usc/21/360hh.md?p=3) of a sole-source unapproved [product](/usc/21/360eee.md?p=13) [authorized](/usc/21/360eee.md?p=2) for emergency use shall report to the [Secretary](/usc/21/321.md?p=d) within a reasonable period of time after the issuance by the [Secretary](/usc/21/321.md?p=d) of such authorization if such [manufacturer](/usc/21/360hh.md?p=3) does not intend to carry out any activity under the authorization. This section only has legal effect on a [person](/usc/21/321.md?p=e) who carries out an activity for which an authorization under this section is issued. This section does not modify or affect activities carried out pursuant to other provisions of this chapter or section 351 of the Public Health Service Act [[42 U.S.C. 262](/usc/42/262.md)]. Nothing in this subsection may be construed as restricting the [Secretary](/usc/21/321.md?p=d) from imposing conditions on [persons](/usc/21/321.md?p=e) who carry out any activity pursuant to an authorization under this section.
- (m) **Categorization of laboratory tests associated with devices subject to authorization—**
  - (1) **In general—** In issuing an authorization under this section with respect to a [device](/usc/21/321.md?p=h-1), the [Secretary](/usc/21/321.md?p=d) may, subject to the provisions of this section, determine that a laboratory examination or procedure associated with such [device](/usc/21/321.md?p=h-1) shall be deemed, for purposes of section 353 of the Public Health Service Act [[42 U.S.C. 263a](/usc/42/263a.md)], to be in a particular category of examinations and procedures (including the category described by [subsection (d)(3)](/usc/42/263a.md?p=d-3) of such section) if, based on the totality of scientific evidence available to the [Secretary](/usc/21/321.md?p=d)—
    - (A) such categorization would be beneficial to protecting the public health; and
    - (B) the known and potential benefits of such categorization under the circumstances of the authorization outweigh the known and potential risks of the categorization.
  - (2) **Conditions of determination—** The [Secretary](/usc/21/321.md?p=d) may establish appropriate conditions on the performance of the examination or procedure pursuant to such determination.
  - (3) **Effective period—** A determination under this subsection shall be effective for purposes of section 353 of the Public Health Service Act [[42 U.S.C. 263a](/usc/42/263a.md)] notwithstanding any other provision of that section during the effective period of the relevant declaration under [subsection (b)](#b).

## Footnotes

[^1]: So in original. Probably should be followed by a period.

## Source credit

(June 25, 1938, ch. 675, § 564, as added Pub. L. 108–136, div. A, title XVI, § 1603(a), Nov. 24, 2003, 117 Stat. 1684; amended Pub. L. 108–276, § 4(a), July 21, 2004, 118 Stat. 853; Pub. L. 113–5, title III, § 302(a), Mar. 13, 2013, 127 Stat. 179; Pub. L. 114–255, div. A, title III, § 3088(a), Dec. 13, 2016, 130 Stat. 1148; Pub. L. 115–92, § 1(a), Dec. 12, 2017, 131 Stat. 2023; Pub. L. 117–328, div. FF, title II, § 2504, Dec. 29, 2022, 136 Stat. 5802.)

## Notes

### Editorial Notes

### References in Text

The Public Health Service Act, referred to in subsec. (a)(3), 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

2022—Subsec. (h)(1). Pub. L. 117–328, § 2504(1)(A), (C), inserted “on the internet website of the Food and Drug Administration and” after “promptly publish” and “, which may include a summary of the data and information supporting such revisions” before period at end of second sentence.

Pub. L. 117–328, § 2504(1)(B), which directed substitution of “application, request, or submission under this section or section 355(b), 355(i), 355(j), 360b(b), 360b(j), 360b(n), 360e, 360(k), 360c(f)(2), 360j(g), 360j(m), 360ccc, or 360ccc–1 of this title, or section 351(a) or 351(k) of the Public Health Service Act, even if such summary may reveal the existence of such an application, request, or submission, or data contained in such application, request, or submission” for “application under section 355(i), 360b(j), or 360j(g) of this title, even if such summary may indirectly reveal the existence of such application”, was executed by making the substitution for “application under section 355(i) 360b(j), or 360j(g) of this title, even if such summary may indirectly reveal the existence of such application”, to reflect the probable intent of Congress.

Subsec. (h)(2). Pub. L. 117–328, § 2504(2), inserted at end “Information made publicly available by the Secretary in accordance with paragraph (1) shall be considered a disclosure authorized by law for purposes of section 1905 of title 18”.

2017—Subsec. (b)(1)(B). Pub. L. 115–92, § 1(a)(1)(A), amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: “a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States military forces of attack with a biological, chemical, radiological, or nuclear agent or agents;”.

Subsec. (b)(6). Pub. L. 115–92, § 1(a)(1)(B), added par. (6).

Subsec. (c)(4), (5). Pub. L. 115–92, § 1(a)(2), added par. (4) and redesignated former par. (4) as (5).

2016—Subsec. (a)(2)(A). Pub. L. 114–255, § 3088(a)(1)(A), substituted “360b, or 360e” for “or 360e” and inserted “or conditionally approved under section 360ccc of this title” after “Public Health Service Act”.

Subsec. (a)(2)(B). Pub. L. 114–255, § 3088(a)(1)(B), inserted “conditionally approved under section 360ccc of this title,” after “approved,” in two places.

Subsec. (b)(4). Pub. L. 114–255, § 3088(a)(2), struck out second comma after “determination”.

Subsec. (e)(3)(B). Pub. L. 114–255, § 3088(a)(3), substituted “subsection (b) or (f) of section 353 of this title or under section 354 of this title” for “section 353(b) of this title”.

Subsec. (f)(2). Pub. L. 114–255, § 3088(a)(4), inserted “, or an animal to which,” after “to a patient to whom” and “or by the veterinarian caring for such animal, as applicable” after “attending physician”.

Subsec. (g)(1). Pub. L. 114–255, § 3088(a)(5), inserted “conditional approval under section 360ccc of this title,” after “approval,”.

Subsec. (h)(1). Pub. L. 114–255, § 3088(a)(6), substituted “360b(j), or 360j(g) of this title” for “or section 360j(g) of this title”.

Subsec. (k). Pub. L. 114–255, § 3088(a)(7), substituted “360b(j), or 360j(g) of this title” for “section 360j(g) of this title,”.

2013—Subsec. (a)(1). Pub. L. 113–5, § 302(a)(1)(A), substituted “any provision of this chapter” for “sections 355, 360(k), and 360e of this title”.

Subsec. (a)(2)(A). Pub. L. 113–5, § 302(a)(1)(B), substituted “under section 355, 360(k), or 360e of this title or section 351 of the Public Health Service Act” for “under a provision of law referred to in such paragraph”.

Subsec. (a)(3). Pub. L. 113–5, § 302(a)(1)(C), substituted “a section of this chapter or the Public Health Service Act referred to in paragraph (2)(A)” for “a provision of law referred to in such paragraph”.

Subsec. (b). Pub. L. 113–5, § 302(a)(2)(A), inserted “or threat justifying emergency authorized use” after “emergency” in heading.

Subsec. (b)(1). Pub. L. 113–5, § 302(a)(2)(B), substituted “may make a declaration that the circumstances exist” for “may declare an emergency” in introductory provisions, struck out “specified” before “biological” in subpars. (A) and (B), added subpar. (D), and amended subpar. (C) generally. Prior to amendment, subpar. (C) read as follows: “a determination by the Secretary of a public health emergency under section 319 of the Public Health Service Act that affects, or has a significant potential to affect, national security, and that involves a specified biological, chemical, radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such agent or agents.”

Subsec. (b)(2)(A)(ii). Pub. L. 113–5, § 302(a)(2)(C)(i), amended cl. (ii) generally. Prior to amendment, cl. (ii) read as follows: “the expiration of the one-year period beginning on the date on which the declaration is made.”

Subsec. (b)(2)(B), (C). Pub. L. 113–5, § 302(a)(2)(C)(ii), (iii), redesignated subpar. (C) as (B) and struck out former subpar. (B). Prior to amendment, text of subpar. (B) read as follows: “Notwithstanding subparagraph (A), the Secretary may renew a declaration under this subsection, and this paragraph shall apply to any such renewal.”

Subsec. (b)(4). Pub. L. 113–5, § 302(a)(2)(D), substituted “, and advance notice of termination under this subsection” for “advance notice of termination, and renewal under this subsection”.

Subsec. (b)(5). Pub. L. 113–5, § 302(a)(2)(E), added par. (5).

Subsec. (c). Pub. L. 113–5, § 302(a)(3)(A), in introductory provisions, inserted “the Assistant Secretary for Preparedness and Response,” after “consultation with” and substituted “Director of the National Institutes of Health, and” for “Director of the National Institutes of Health and” and “applicable circumstances described in subsection (b)(1)” for “circumstances of the emergency involved”.

Subsec. (c)(1). Pub. L. 113–5, § 302(a)(3)(B), substituted “referred to” for “specified”.

Subsec. (c)(2)(B). Pub. L. 113–5, § 302(a)(3)(C), inserted “, taking into consideration the material threat posed by the agent or agents identified in a declaration under subsection (b)(1)(D), if applicable” after “risks of the product”.

Subsec. (d)(3). Pub. L. 113–5, § 302(a)(4), inserted “, to the extent practicable given the circumstances of the emergency,” after “including”.

Subsec. (e)(1)(A). Pub. L. 113–5, § 302(a)(5)(A), substituted “applicable circumstances described in subsection (b)(1)” for “circumstances of the emergency” in introductory provisions.

Subsec. (e)(1)(B)(iii). Pub. L. 113–5, § 302(a)(5)(B), amended cl. (iii) generally. Prior to amendment, cl. (iii) read as follows: “Appropriate conditions with respect to the collection and analysis of information, during the period when the authorization is in effect, concerning the safety and effectiveness of the product with respect to the emergency use of such product.”

Subsec. (e)(2)(A). Pub. L. 113–5, § 302(a)(5)(C)(i), substituted “person” for “manufacturer of the product” and “applicable circumstances described in subsection (b)(1)” for “circumstances of the emergency” and inserted “or in paragraph (1)(B)” before period at end.

Subsec. (e)(2)(B)(i). Pub. L. 113–5, § 302(a)(5)(C)(ii), inserted “, except as provided in section 360bbb–3a of this title with respect to authorized changes to the product expiration date” before period at end.

Subsec. (e)(2)(C). Pub. L. 113–5, § 302(a)(5)(C)(iii), amended subpar. (C) generally. Prior to amendment, subpar. (C) read as follows: “The Secretary may establish with respect to the distribution and administration of the product for the unapproved use conditions no more restrictive than those established by the Secretary with respect to the distribution and administration of the product for the approved use.”

Subsec. (e)(3). Pub. L. 113–5, § 302(a)(5)(D), amended par. (3) generally. Prior to amendment, text read as follows: “With respect to the emergency use of a product for which an authorization under this section is issued (whether an unapproved product or an unapproved use of an approved product), the Secretary may waive or limit, to the extent appropriate given the circumstances of the emergency, requirements regarding current good manufacturing practice otherwise applicable to the manufacture, processing, packing, or holding of products subject to regulation under this chapter, including such requirements established under section 351 of this title.”

Subsec. (g). Pub. L. 113–5, § 302(a)(6)(A), substituted “Review and revocation” for “Revocation” in heading.

Subsec. (g)(1). Pub. L. 113–5, § 302(a)(6)(B), inserted at end “As part of such review, the Secretary shall regularly review the progress made with respect to the approval, licensure, or clearance of—

“(A) an unapproved product for which an authorization was issued under this section; or

“(B) an unapproved use of an approved product for which an authorization was issued under this section.”

Subsec. (g)(2). Pub. L. 113–5, § 302(a)(6)(C), amended par. (2) generally. Prior to amendment, text read as follows: “The Secretary may revoke an authorization under this section if the criteria under subsection (c) of this section for issuance of such authorization are no longer met or other circumstances make such revocation appropriate to protect the public health or safety.”

Subsec. (h)(1). Pub. L. 113–5, § 302(a)(7), inserted at end “The Secretary shall make any revisions to an authorization under this section available on the Internet Web site of the Food and Drug Administration.”

Subsec. (j)(4). Pub. L. 113–5, § 302(a)(8), added par. (4).

Subsec. (m). Pub. L. 113–5, § 302(a)(9), added subsec. (m).

2004—Pub. L. 108–276 amended section generally, substituting provisions of subsecs. (a) to (l) for similar former provisions, except for additional provisions in subsec. (b)(1) allowing Secretary to authorize use of medical products in actual or potential domestic and public health emergencies in addition to actual or potential military emergencies.

### Executive Documents

### Making General Use Respirators Available

Memorandum of President of the United States, Mar. 11, 2020, 85 F.R. 15049, provided:

Memorandum for the Secretary of Health and Human Services [and] the Secretary of Labor

By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:

It is the policy of the United States to take proactive measures to prepare for and respond to public health threats, including the public health emergency involving Coronavirus Disease 2019 (COVID–19), which was declared by the Secretary of Health and Human Services on February 4, 2020, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3). We must ensure that our healthcare providers have full access to the products they need. On March 10, 2020, the Secretary of Health and Human Services took action by issuing a declaration pursuant to section 319F–3 of the Public Health Service Act (42 U.S.C. 247d–6d), which will help bring products necessary for addressing the epidemic to healthcare providers across the Nation. Unfortunately, at present, public health experts anticipate shortages in the supply of personal respiratory devices (respirators) available for use by healthcare workers in mitigating further transmission of COVID–19.

To help prevent the spread of COVID–19, the Secretary of Health and Human Services shall take all appropriate and necessary steps with respect to general use respirators to facilitate their emergency use by healthcare personnel in healthcare facilities and elsewhere, including under the authorities granted by section 319F–3 of the Public Health Service Act (42 U.S.C. 247d–6d) and section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3). Additionally, the Secretary of Labor shall consider all appropriate and necessary steps to increase the availability of respirators.

The Secretary of Health and Human Services is authorized and directed to publish this memorandum in the Federal Register.