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21 U.S.C. § 360bbb–3b — Products held for emergency use

Verified against govinfo.gov as of June 20, 2026View official text on govinfo.gov ↗
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. (1)is intended to be held and not used; and
  2. (2)is held and not used, unless and until that product—
    1. (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;
    2. (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
    3. (C)is authorized for use under section 360bbb–3 of this title or section 360bbb–3a of this title.