21 USC 360bbb-3b - Products held for emergency use

U.S Code last checked for updates: Nov 22, 2024

§ 360bbb–3b.

Products held for emergency use

It is not a violation of any section of this chapter or of the Public Health Service Act [42 U.S.C. 201 et seq.] 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 360bbb–3(a)(4) of this title) intended for emergency use, if that product—

(1)

is intended to be held and not used; and

(2)

is held and not used, unless and until that product—

(A)

is approved, cleared, or licensed under section 355, 360(k), 360b, or 360e of this title or section 351 of the Public Health Service Act [42 U.S.C. 262] or conditionally approved under section 360ccc of this title;

(B)

is authorized for investigational use under section 355, 360b, or 360j of this title or section 351 of the Public Health Service Act [42 U.S.C. 262]; or

(C)

is authorized for use under section 360bbb–3 of this title or section 360bbb–3a of this title.

(June 25, 1938, ch. 675, § 564B, as added Pub. L. 113–5, title III, § 302(d), Mar. 13, 2013, 127 Stat. 185; amended Pub. L. 114–255, div. A, title III, § 3088(d), Dec. 13, 2016, 130 Stat. 1149; Pub. L. 116–22, title VII, § 705(d), June 24, 2019, 133 Stat. 964.)

cite as: 21 USC 360bbb-3b