PRODUCTS HELD FOR EMERGENCY USE.

SEC. 564B. [21 U.S.C. 360bbb–3b] PRODUCTS HELD FOR EMERGENCY USE. It is not a violation of any section of this Act or of the Public Health Service Act 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 564(a)(4)) 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 505, 510(k), 512, or 515 of this Act or section 351 of the Public Health Service Act or conditionally approved under section 571 of this Act; (B) is authorized for investigational use under section 505, 512, or 520 of this Act or section 351 of the Public Health Service Act; or (C) is authorized for use under section 564 or section 564A.