21 U.S. Code § 360bbb–3a - Emergency use of medical products
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(a)
Definitions
In this section:
(1)
Eligible product
The term “eligible product” means a product that—
(A)
is approved or cleared under this subchapter or licensed under section 351 of the Public Health Service Act [42 U.S.C. 262];
(B)
(b)
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—
(2)
Requirements and conditions
Any extension of an expiration date under paragraph (1) shall, as part of the extension, identify—
(A)
each specific lot, batch, or other unit of the product for which extended expiration is authorized;
(C)
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.
(3)
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.
(4)
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.
(c)
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.
(2)
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 authorized deviations from current good manufacturing practices under paragraph (1).
(d)
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—
(e)
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.
(2)
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—
Source
(June 25, 1938, ch. 675, § 564A, as added Pub. L. 113–5, title III, § 302(b),Mar. 13, 2013, 127 Stat. 183.)
References in Text
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.
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