§ 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 .