21 U.S. Code § 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.)

Editorial Notes

References in Text

The Public Health Service Act, referred to in text, 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.

Amendments

2019—Par. (2)(B). Pub. L. 116–22, § 705(d)(1), inserted comma after “355”.

Par. (2)(C). Pub. L. 116–22, § 705(d)(2), inserted “or section 360bbb–3a of this title” before period at end.

2016—Par. (2)(A). Pub. L. 114–255, § 3088(d)(1), substituted “360b, or 360e of this title” for “or 360e of this title” and inserted “or conditionally approved under section 360ccc of this title” after “Public Health Service Act”.

Par. (2)(B). Pub. L. 114–255, § 3088(d)(2), substituted “360b, or 360j of this title” for “or 360j of this title”.