{"identifier":"/us/usc/t21/s360bbb\u20133b","title":21,"num":"\u00a7\u202f360bbb\u20133b.","heading":"Products held for emergency use","text":"\u00a7\u202f360bbb\u20133b.\nProducts held for emergency use\nIt is not a violation of any section of this chapter or of the Public Health Service Act [\n(1) is intended to be held and not used; and\n(2) is held and not used, unless and until that product\u2014\n(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 [\n42 U.S.C. 262\nsection 360ccc of this title\n(B) is authorized for investigational use under section 355, 360b, or 360j of this title or section 351 of the Public Health Service Act [\n42 U.S.C. 262\n(C) is authorized for use under\nsection 360bbb\u20133 of this title\nsection 360bbb\u20133a of this title","url":"https://projectusc.org/usc/t21/s360bbb\u20133b.html","content":[{"t":"sec","id":"/us/usc/t21/s360bbb\u20133b","children":[{"t":"num","text":"\u00a7\u202f360bbb\u20133b."},{"t":"heading","text":"Products held for emergency use","tail":"\n"},{"t":"chapeau","text":"It is not a violation of any section of this chapter or of the Public Health Service Act [","children":[{"t":"ref","text":"42 U.S.C. 201","href":"/us/usc/t42/s201","tail":" 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 "},{"t":"ref","text":"section 360bbb\u20133(a)(4) of this title","href":"/us/usc/t21/s360bbb\u20133/a/4","tail":") intended for emergency use, if that product\u2014"}]},{"t":"para","id":"/us/usc/t21/s360bbb\u20133b/1","children":[{"t":"num","text":"(1)"},{"t":"content","text":" is intended to be held and not used; and","tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s360bbb\u20133b/2","children":[{"t":"num","text":"(2)"},{"t":"chapeau","text":" is held and not used, unless and until that product\u2014"},{"t":"subpara","id":"/us/usc/t21/s360bbb\u20133b/2/A","children":[{"t":"num","text":"(A)"},{"t":"content","text":" 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 [","children":[{"t":"ref","text":"42 U.S.C. 262","href":"/us/usc/t42/s262","tail":"] or conditionally approved under "},{"t":"ref","text":"section 360ccc of this title","href":"/us/usc/t21/s360ccc","tail":";"}],"tail":"\n"}],"tail":"\n"},{"t":"subpara","id":"/us/usc/t21/s360bbb\u20133b/2/B","children":[{"t":"num","text":"(B)"},{"t":"content","text":" is authorized for investigational use under section 355, 360b, or 360j of this title or section 351 of the Public Health Service Act [","children":[{"t":"ref","text":"42 U.S.C. 262","href":"/us/usc/t42/s262","tail":"]; or"}],"tail":"\n"}],"tail":"\n"},{"t":"subpara","id":"/us/usc/t21/s360bbb\u20133b/2/C","children":[{"t":"num","text":"(C)"},{"t":"content","text":" is authorized for use under ","children":[{"t":"ref","text":"section 360bbb\u20133 of this title","href":"/us/usc/t21/s360bbb\u20133","tail":" or "},{"t":"ref","text":"section 360bbb\u20133a of this title","href":"/us/usc/t21/s360bbb\u20133a","tail":"."}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"text","text":"\n"},{"t":"text","text":"\n"}]}]}