21 U.S.C. § 360bbb: Emergency use of medical products

is approved or cleared under this subchapter, conditionally approved under section 360ccc of this title , or licensed under section 351 of the Public Health Service Act [ 42 U.S.C. 262 ]; is intended for use to prevent, diagnose, or treat a disease or condition involving a biological, chemical, radiological, or nuclear agent or agents; or is intended for use to prevent, diagnose, or treat a serious or life-threatening disease or condition caused by a product described in clause (i); and a determination described in subparagraph (A), (B), or (C) of section 360bbb–3(b)(1) of this title has been made by the Secretary of Homeland Security, the Secretary of Defense, or the Secretary, respectively; or the identification of a material threat described in subparagraph (D) of section 360bbb–3(b)(1) of this title has been made pursuant to section 319F–2 of the Public Health Service Act [ 42 U.S.C. 247d–6b ]. The term “product” means a drug, device, or biological product. the public health; or military preparedness and effectiveness; and the expiration date extension is supported by an appropriate scientific evaluation that is conducted or accepted by the Secretary. each specific lot, batch, or other unit of the product for which extended expiration is authorized; the duration of the extension; and any other requirements or conditions as the Secretary may deem appropriate for the protection of the public health, which may include requirements for, or conditions on, product sampling, storage, packaging or repackaging, transport, labeling, notice to product recipients, recordkeeping, periodic testing or retesting, or product disposition. Notwithstanding any other provision of this chapter or the Public Health Service Act [ 42 U.S.C. 201 et seq.], an eligible product shall not be considered an unapproved product (as defined in section 360bbb–3(a)(2)(A) of this title ) and shall not be deemed adulterated or misbranded under this chapter because, with respect to such product, the Secretary has, under paragraph (1), extended the expiration date and authorized the introduction or delivery for introduction into interstate commerce of such product after the expiration date provided by the manufacturer. 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 to ensure that the product meets applicable standards of identity, strength, quality, and purity at the time of use. The Secretary may, when the circumstances of a domestic, military, or public health emergency or material threat described in subsection (a)(1)(C) so warrant, authorize, with respect to an eligible product, deviations from current good manufacturing practice requirements otherwise applicable to the manufacture, processing, packing, or holding of products subject to regulation under this chapter, including requirements under section 351 or 360j(f)(1) of this title or applicable conditions prescribed with respect to the eligible product by an order under section 360j(f)(2) of this title . Notwithstanding any other provision of this chapter or the Public Health Service Act [ 42 U.S.C. 201 et seq.], an eligible product shall not be considered an unapproved product (as defined in section 360bbb–3(a)(2)(A) of this title ) and shall not be deemed adulterated or misbranded under this chapter because, with respect to such product, the Secretary has authorized deviations from current good manufacturing practices under paragraph (1). the product is dispensed during the circumstances described in subsection (a)(1)(C); and as permitted under the law of the State in which the product is dispensed; or in accordance with an order issued by the Secretary, for the purposes and duration of the circumstances described in subsection (a)(1)(C). The Secretary, acting through an appropriate official within the Department of Health and Human Services, may create and issue emergency use instructions to inform health care providers or individuals to whom an eligible product is to be administered concerning such product’s approved, licensed, or cleared conditions of use. during an emergency response to an actual emergency that is the basis for a determination described in subsection (a)(1)(C); or by a government entity (including a Federal, State, local, or tribal government entity), or a person acting on behalf of such a government entity, in preparation for an emergency response.