21 U.S.C. § 360bbb–3b: Products held for…

Summary

Allows a Federal, State, local, or tribal government, or someone acting for one, to move an emergency-use product across state lines without breaking certain federal laws, as long as the product is meant to be stored and is actually kept unused. The product must stay stored until one of these happens: it is approved, cleared, licensed, or conditionally approved under sections 355, 360(k), 360b, 360e, or 351 (42 U.S.C. 262); it is OK’d for investigational use under sections 355, 360b, 360j, or 351; or it is authorized under section 360bbb–3 or 360bbb–3a. product — the item meant for emergency use (see section 360bbb–3(a)(4)).

Title 21, §360bbb–3b

Food and Drugs, Source: USLM XML via OLRC

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.

Notes & Related Subsidiaries

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”.

§360bbb–3b Products Held for Emergency Use