2024 U.S. Code
Title 21 - Food and Drugs
Chapter 9 - Federal Food, Drug, and Cosmetic Act
Subchapter V - Drugs and Devices
Part E - General Provisions Relating to Drugs and Devices
Sec. 360bbb-3b - Products held for emergency use
| 21 U.S.C. § 360bbb-3b (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.) |
|
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. AMENDMENTS2019—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". |
| United States Code, 2024 Edition, Title 21 - FOOD AND DRUGS |
| Bills and Statutes |
| United States Code |
| Y 1.2/5: |
| Title 21 - FOOD AND DRUGS CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT SUBCHAPTER V - DRUGS AND DEVICES Part E - General Provisions Relating to Drugs and Devices Sec. 360bbb-3b - Products held for emergency use |
| section 360bbb-3b |
| 2024 |
| January 6, 2025 |
| No |
| standard |
| 58 Stat. 682 127 Stat. 185 130 Stat. 1149 133 Stat. 964 |
| Public Law 113-5, Public Law 114-255, Public Law 116-22 |
