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21 U.S. Code § 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], and subject to the provisions of this section, the Secretary may authorize the introduction into interstate commerce, during the effective period of a declaration under subsection (b), of a drug, device, or biological product intended for use in an actual or potential emergency (referred to in this section as an “emergency use”).
(2) Approval status of productAn authorization under paragraph (1) may authorize an emergency use of a product that—
(A)
is not approved, licensed, or cleared for commercial distribution under section 355, 360(k), 360b, or 360e of this title or section 351 of the Public Health Service Act [42 U.S.C. 262] or conditionally approved under section 360ccc of this title (referred to in this section as an “unapproved product”); or
(B)
is approved, conditionally approved under section 360ccc of this title, licensed, or cleared under such a provision, but which use is not under such provision an approved, conditionally approved under section 360ccc of this title, licensed, or cleared use of the product (referred to in this section as an “unapproved use of an approved product”).
(3) Relation to other uses
An emergency use authorized under paragraph (1) for a product is in addition to any other use that is authorized for the product under a section of this chapter or the Public Health Service Act [42 U.S.C. 201 et seq.] referred to in paragraph (2)(A).
(4) DefinitionsFor purposes of this section:
(A)
The term “biological product” has the meaning given such term in section 351 of the Public Health Service Act [42 U.S.C. 262].
(B)
The term “emergency use” has the meaning indicated for such term in paragraph (1).
(C)
The term “product” means a drug, device, or biological product.
(D)
The term “unapproved product” has the meaning indicated for such term in paragraph (2)(A).
(E)
The term “unapproved use of an approved product” has the meaning indicated for such term in paragraph (2)(B).
(b) Declaration of emergency or threat justifying emergency authorized use
(1) In generalThe Secretary may make a declaration that the circumstances exist justifying the authorization under this subsection for a product on the basis of—
(A)
a determination by the Secretary 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 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 or title 50, 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 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] sufficient to affect national security or the health and security of United States citizens living abroad.