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Co-Authored-By: Claude Opus 4.8 <noreply@anthropic.com>
2026-07-06 10:51:44 -04:00

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LegalText 21 U.S.C. § 360bbb3b Products held for emergency use us united_states_code code_section 21 FOOD AND DRUGS 9 FEDERAL FOOD, DRUG, AND COSMETIC ACT 360bbb3b 21 U.S.C. § 360bbb3b current 119-100 2026-06-26 official https://uscode.house.gov/download/releasepoints/us/pl/119/100/xml_usc21@119-100.zip /us/usc/t21/s360bbb3b data/legal/raw/us/code/title-21/usc21.xml fabbbd3dffe27f5cda98bc6835bbb705aae6a8f3cd825d86625de232564bde10 3dbd7a61c8616baefb8459bd8dac3b93242106deb416308c8d4dd5a9143176d1 d7658d72a3a04693b6ab58351e638c1cf3ad6ad8b0233b095ffa39d6f1c3829c 2026-07-04 official
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21 U.S.C. § 360bbb3b - Products held for emergency use

Text

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 360bbb3(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 360bbb3 of this title or section 360bbb3a of this title.

(June 25, 1938, ch. 675, § 564B, as added Pub. L. 1135, title III, § 302(d), Mar. 13, 2013, 127 Stat. 185; amended Pub. L. 114255, div. A, title III, § 3088(d), Dec. 13, 2016, 130 Stat. 1149; Pub. L. 11622, title VII, § 705(d), June 24, 2019, 133 Stat. 964.)

Notes

Editorial Notes

References in TextThe 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. 11622, § 705(d)(1), inserted comma after “355”. Par. (2)(C). Pub. L. 11622, § 705(d)(2), inserted “or section 360bbb3a of this title” before period at end. 2016—Par. (2)(A). Pub. L. 114255, § 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. 114255, § 3088(d)(2), substituted “360b, or 360j of this title” for “or 360j of this title”.