US Code

Public Law 119-73 (01/23/2026)

21 U.S.C. § 360bbb–3b

Products held for emergency use

42 U.S.C. 201section 360bbb–3(a)(4) of this titleIt is not a violation of any section of this chapter or of the Public Health Service Act [ 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 ) 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)
42 U.S.C. 262section 360ccc of this title 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 [] or conditionally approved under ;
(B)
42 U.S.C. 262 is authorized for investigational use under section 355, 360b, or 360j of this title or section 351 of the Public Health Service Act []; or
(C)
section 360bbb–3 of this titlesection 360bbb–3a of this title is authorized for use under or .

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

Editorial Notes

References in Text

act July 1, 1944, ch. 37358 Stat. 682section 201 of Title 42The Public Health Service Act, referred to in text, 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. 116–22, § 705(d)(1)2019—Par. (2)(B). , inserted comma after “355”.

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

Pub. L. 114–255, § 3088(d)(1)section 360ccc of this title2016—Par. (2)(A). , substituted “360b, or 360e of this title” for “or 360e of this title” and inserted “or conditionally approved under ” after “Public Health Service Act”.

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