21 U.S.C. § 360bbb–3a | Emergency use of medical products

(a)

Definitions

In this section:

(1)

Eligible product

The term “eligible product” means a product that—

(A)

section 360ccc of this title 42 U.S.C. 262 is approved or cleared under this subchapter, conditionally approved under , or licensed under section 351 of the Public Health Service Act [];

(B)

(i)

is intended for use to prevent, diagnose, or treat a disease or condition involving a biological, chemical, radiological, or nuclear agent or agents; or

(ii)

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

(C)

is intended for use during the circumstances under which—

(i)

section 360bbb–3(b)(1) of this title a determination described in subparagraph (A), (B), or (C) of has been made by the Secretary of Homeland Security, the Secretary of Defense, or the Secretary, respectively; or

(ii)

section 360bbb–3(b)(1) of this title 42 U.S.C. 247d–6b the identification of a material threat described in subparagraph (D) of has been made pursuant to section 319F–2 of the Public Health Service Act [].

(2)

Product

The term “product” means a drug, device, or biological product.

(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—

(A)

the expiration date extension is intended to support the United States ability to protect—

(i)

the public health; or

(ii)

military preparedness and effectiveness; and

(B)

the expiration date extension is supported by an appropriate scientific evaluation that is conducted or accepted by the Secretary.

(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;

(B)

the duration of the extension; and

(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

42 U.S.C. 201 section 360bbb–3(a)(2)(A) of this titleNotwithstanding any other provision of this chapter or the Public Health Service Act [ et seq.], an eligible product shall not be considered an unapproved product (as defined in ) 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

section 360j(f)(2) of this titleThe 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 .

(2)

Effect

42 U.S.C. 201 section 360bbb–3(a)(2)(A) of this titleNotwithstanding any other provision of this chapter or the Public Health Service Act [ et seq.], an eligible product shall not be considered an unapproved product (as defined in ) 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

section 360j(e) of this title section 360bbb–3(a)(2)(A) of this titleThe requirements of subsections (b) and (f) of section 353, section 354, and shall not apply to an eligible product, and the product shall not be considered an unapproved product (as defined in ) and shall not be deemed adulterated or misbranded under this chapter because it is dispensed without an individual prescription, if—

(1)

the product is dispensed during the circumstances described in subsection (a)(1)(C); and

(2)

such dispensing without an individual prescription occurs—

(A)

as permitted under the law of the State in which the product is dispensed; or

(B)

in accordance with an order issued by the Secretary, for the purposes and duration of the circumstances described in subsection (a)(1)(C).

(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

42 U.S.C. 201Notwithstanding any other provisions of this chapter or the Public Health Service Act [ 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—

(A)

during an emergency response to an actual emergency that is the basis for a determination described in subsection (a)(1)(C); or

(B)

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 Pub. L. 113–5, title III, § 302(b)Mar. 13, 2013127 Stat. 183 Pub. L. 114–255, div. A, title III, § 3088(c)Dec. 13, 2016130 Stat. 1149 Pub. L. 116–22, title VII, § 705(c)June 24, 2019133 Stat. 964(, as added , , ; amended , , ; , , .)

Editorial Notes

References in Text

act July 1, 1944, ch. 373 58 Stat. 682 section 201 of Title 42The Public Health Service Act, referred to in subsecs. (b)(3), (c)(2), and (e)(2), is , , 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 and Tables.

Amendments

Pub. L. 116–222019—Subsec. (e)(2)(A). substituted “subsection (a)(1)(C)” for “subsection (a)(1)(C)(i)”.

Pub. L. 114–255, § 3088(c)(1)section 360ccc of this title2016—Subsec. (a)(1)(A). , inserted “, conditionally approved under ,” after “subchapter”.

Pub. L. 114–255, § 3088(c)(2)section 360j(e) of this titleSubsec. (d). , substituted “subsections (b) and (f) of section 353, section 354, and ” for “sections 353(b) and 360j(e) of this title” in introductory provisions.