Source: https://www.law.cornell.edu/uscode/text/21/360bbb-3a?quicktabs_8=3
Timestamp: 2016-02-09 21:22:55
Document Index: 581062322

Matched Legal Cases: ['§ 360', '§ 360', '§ 360', '§ 564', '§ 302', '§ 201', 'art 4', 'art 5', 'art 7', 'art 10', 'art 11', 'art 12', 'art 13', 'art 14', 'art 15', 'art 16', 'art 20', 'art 25', 'art 312']

21 U.S. Code § 360bbb–3a - Emergency use of medical products | US Law | LII / Legal Information Institute
U.S. Code › Title 21 › Chapter 9 › Subchapter V › Part E › § 360bbb–3a 21 U.S. Code § 360bbb–3a - Emergency use of medical products
Eligible product The term “eligible product” means a product that—
is approved or cleared under this subchapter 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
is intended for use during the circumstances under which—
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].
Product The term “product” means a drug, device, or biological product.
Expiration dating (1)
In general 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.
Requirements and conditions 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.
Effect 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.
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 to ensure that the product meets applicable standards of identity, strength, quality, and purity at the time of use.
Current good manufacturing practice (1)
In general 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.
(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).
Emergency dispensing The requirements of sections 353
(b) and 360j
(e) of this title shall not apply to an eligible product, and the 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 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).
Emergency use instructions (1)
In general 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.
Effect Notwithstanding any other provisions of this chapter or the Public Health Service Act [42 U.S.C. 201 et seq.], a product shall not be considered an unapproved product and shall not be deemed adulterated or misbranded under this chapter 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.
(June 25, 1938, ch. 675, § 564A, as added Pub. L. 113–5, title III, § 302(b),Mar. 13, 2013, 127 Stat. 183.)
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.
This is a list of parts within the Code of Federal Regulations for which this US Code section provides rulemaking authority.This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.21 CFR - Food and Drugs21 CFR Part 4 - REGULATION OF COMBINATION PRODUCTS21 CFR Part 5 - ORGANIZATION21 CFR Part 7 - ENFORCEMENT POLICY21 CFR Part 10 - ADMINISTRATIVE PRACTICES AND PROCEDURES21 CFR Part 11 - ELECTRONIC RECORDS; ELECTRONIC SIGNATURES21 CFR Part 12 - FORMAL EVIDENTIARY PUBLIC HEARING21 CFR Part 13 - PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY21 CFR Part 14 - PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE21 CFR Part 15 - PUBLIC HEARING BEFORE THE COMMISSIONER21 CFR Part 16 - REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION21 CFR Part 20 - PUBLIC INFORMATION21 CFR Part 25 - ENVIRONMENTAL IMPACT CONSIDERATIONS21 CFR Part 312 - INVESTIGATIONAL NEW DRUG APPLICATION