Sec. 302. Authorization for medical products for use in emergencies
2,472 words·~11 min read·
/bill/113/hr/307/eas/section-302A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 564 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–3 ) is amended— in subsection (a)— in paragraph (1), by striking sections 505, 510(k), and 515 of this Act and inserting any provision of this Act ; in paragraph (2)(A), by striking under a provision of law referred to in such paragraph and inserting under section 505, 510(k), or 515 of this Act or section 351 of the Public Health Service Act ; and in paragraph (3), by striking a provision of law referred to in such paragraph and inserting a section of this Act or the Public Health Service Act referred to in paragraph (2)(A) ; in subsection (b)— in the subsection heading, by striking and inserting Emergency ;
Emergency or Threat Justifying Emergency Authorized Use in paragraph (1)— in the matter preceding subparagraph (A), by striking may declare an emergency and inserting may make a declaration that the circumstances exist ; in subparagraph (A), by striking specified ; in subparagraph (B)— by striking specified ; and by striking ; or and inserting a semicolon; by amending subparagraph
(C)to read as follows: 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 ; and by adding at the end the following: the identification of a material threat pursuant to section 319F–2 of the Public Health Service Act sufficient to affect national security or the health and security of United States citizens living abroad. ; in paragraph (2)— in subparagraph (A), by amending clause
(ii)to read as follows: a change in the approval status of the product such that the circumstances described in subsection (a)(2) have ceased to exist. ; by striking subparagraph (B); and by redesignating subparagraph
(C)as subparagraph (B); in paragraph (4), by striking advance notice of termination, and renewal under this subsection. and inserting , and advance notice of termination under this subsection. ; and by adding at the end the following: If an authorization under this section with respect to an unapproved product or an unapproved use of an approved product has been in effect for more than 1 year, the Secretary shall provide in writing to the sponsor of such product an explanation of the scientific, regulatory, or other obstacles to approval, licensure, or clearance of such product or use, including specific actions to be taken by the Secretary and the sponsor to overcome such obstacles. ; in subsection (c)— in the matter preceding paragraph (1)— by inserting the Assistant Secretary for Preparedness and Response, after consultation with ; by striking Health and and inserting Health, and ; and by striking circumstances of the emergency involved and inserting applicable circumstances described in subsection (b)(1) ; in paragraph (1), by striking specified and inserting referred to ; and in paragraph (2)(B), by inserting , 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 ; in subsection (d)(3), by inserting , to the extent practicable given the circumstances of the emergency, after including ; in subsection (e)— in paragraph (1)(A), by striking circumstances of the emergency and inserting applicable circumstances described in subsection (b)(1) ; in paragraph (1)(B), by amending clause
(iii)to read as follows: Appropriate conditions with respect to collection and analysis of information concerning the safety and effectiveness of the product with respect to the use of such product during the period when the authorization is in effect and a reasonable time following such period. ; in paragraph (2)— in subparagraph (A)— by striking manufacturer of the product and inserting person ; by striking circumstances of the emergency and inserting applicable circumstances described in subsection (b)(1) ; and by inserting at the end before the period or in paragraph (1)(B) ; in subparagraph (B)(i), by inserting before the period at the end , except as provided in section 564A with respect to authorized changes to the product expiration date ; and by amending subparagraph
(C)to read as follows: In establishing conditions under this paragraph with respect to the distribution and administration of the product for the unapproved use, the Secretary shall not impose conditions that would restrict distribution or administration of the product when distributed or administered for the approved use. ; and by amending paragraph
(3)to 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 applicable circumstances described in subsection (b)(1)— requirements regarding current good manufacturing practice otherwise applicable to the manufacture, processing, packing, or holding of products subject to regulation under this Act, including such requirements established under section 501 or 520(f)(1), and including relevant conditions prescribed with respect to the product by an order under section 520(f)(2); requirements established under section 503(b); and requirements established under section 520(e). ; in subsection (g)— in the subsection heading, by inserting before Review and ; Revocation in paragraph (1), by inserting after the period at the end the following: “As part of such review, the Secretary shall regularly review the progress made with respect to the approval, licensure, or clearance of— an unapproved product for which an authorization was issued under this section; or an unapproved use of an approved product for which an authorization was issued under this section. ; and by amending paragraph
(2)to read as follows: The Secretary may revise or revoke an authorization under this section if— the circumstances described under subsection (b)(1) no longer exist; the criteria under subsection
(c)for issuance of such authorization are no longer met; or other circumstances make such revision or revocation appropriate to protect the public health or safety. ; in subsection (h)(1), by adding after the period at the end the following: The Secretary shall make any revisions to an authorization under this section available on the Internet Web site of the Food and Drug Administration. ; by adding at the end of subsection
(j)the following: Nothing in this section shall be construed as authorizing a delay in the review or other consideration by the Secretary of any application or submission pending before the Food and Drug Administration for a product for which an authorization under this section is issued. ; and by adding at the end the following: In issuing an authorization under this section with respect to a device, the Secretary may, subject to the provisions of this section, determine that a laboratory examination or procedure associated with such device shall be deemed, for purposes of section 353 of the Public Health Service Act, to be in a particular category of examinations and procedures (including the category described by subsection (d)(3) of such section) if, based on the totality of scientific evidence available to the Secretary— such categorization would be beneficial to protecting the public health; and the known and potential benefits of such categorization under the circumstances of the authorization outweigh the known and potential risks of the categorization. The Secretary may establish appropriate conditions on the performance of the examination or procedure pursuant to such determination. A determination under this subsection shall be effective for purposes of section 353 of the Public Health Service Act notwithstanding any other provision of that section during the effective period of the relevant declaration under subsection (b). . Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by inserting after section 564 the following: In this section: The term eligible product means a product that— is approved or cleared under this chapter or licensed under section 351 of the Public Health Service Act; 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 is intended for use during the circumstances under which— a determination described in subparagraph (A), (B), or
(C)of section 564(b)(1) 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 564(b)(1) has been made pursuant to section 319F–2 of the Public Health Service Act. The term product means a drug, device, or biological product. The Secretary may extend the expiration date and authorize the introduction or delivery for introduction into interstate commerce of an eligible product after the expiration date provided by the manufacturer if— the expiration date extension is intended to support the United States ability to protect— 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. Any extension of an expiration date under paragraph
(1)shall, as part of the extension, identify— 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 Act or the Public Health Service Act, an eligible product shall not be considered an unapproved product (as defined in section 564(a)(2)(A)) and shall not be deemed adulterated or misbranded under this Act 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 Act, including requirements under section 501 or 520(f)(1) or applicable conditions prescribed with respect to the eligible product by an order under section 520(f)(2). Notwithstanding any other provision of this Act or the Public Health Service Act, an eligible product shall not be considered an unapproved product (as defined in section 564(a)(2)(A)) and shall not be deemed adulterated or misbranded under this Act because, with respect to such product, the Secretary has authorized deviations from current good manufacturing practices under paragraph (1). The requirements of sections 503(b) and 520(e) shall not apply to an eligible product, and the product shall not be considered an unapproved product (as defined in section 564(a)(2)(A)) and shall not be deemed adulterated or misbranded under this Act because it is dispensed without an individual prescription, if— the product is dispensed during the circumstances described in subsection (a)(1)(C); and such dispensing without an individual prescription occurs— 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. Notwithstanding any other provisions of this Act or the Public Health Service Act, a product shall not be considered an unapproved product and shall not be deemed adulterated or misbranded under this Act because of the issuance of emergency use instructions under paragraph
(1)with respect to such product or the introduction or delivery for introduction of such product into interstate commerce accompanied by such instructions— during an emergency response to an actual emergency that is the basis for a determination described in subsection (a)(1)(C)(i); 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. . Section 505–1 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355–1 ), is amended— in subsection (f), by striking paragraph (7); and by adding at the end the following: The Secretary may waive any requirement of this section with respect to a qualified countermeasure (as defined in section 319F–1(a)(2) of the Public Health Service Act) to which a requirement under this section has been applied, if the Secretary determines that such waiver is required to mitigate the effects of, or reduce the severity of, the circumstances under which— a determination described in subparagraph (A), (B), or
(C)of section 564(b)(1) 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 564(b)(1) has been made pursuant to section 319F–2 of the Public Health Service Act. . The Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq. ) is amended by inserting after section 564A, as added by subsection (b), the following: It is not a violation of any section of this Act or of the Public Health Service Act for a government entity (including a Federal, State, local, or tribal government entity), or a person acting on behalf of such a government entity, to introduce into interstate commerce a product (as defined in section 564(a)(4)) intended for emergency use, if that product— is intended to be held and not used; and is held and not used, unless and until that product— is approved, cleared, or licensed under section 505, 510(k), or 515 of this Act or section 351 of the Public Health Service Act; is authorized for investigational use under section 505 or 520 of this Act or section 351 of the Public Health Service Act; or is authorized for use under section 564. .
Connectionstraces to 2
Traces to 2 documents
2 references not yet in our index
- 21 USC 360bbb–3
- 21 USC 355–1
Citation graph
cites case law
Sec. 302
Authorization for medical products for use in emergencies
Cite21 USC 360bbb–3
Cite21 USC 355–1
Cites 4Cited by 0 across 0 sources