Sec. 3088. CLARIFYING FOOD AND DRUG ADMINISTRATION EMERGENCY USE AUTHORIZATION
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## SEC. 3088 CLARIFYING FOOD AND DRUG ADMINISTRATION EMERGENCY USE AUTHORIZATION ###
(a)Authorization for Medical Products for Use in Emergencies Section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3) is amended— ####
(1)in subsection (a)(2)— #####
(A)in subparagraph (A)— ######
(i)by striking “or 515” and inserting “512, or 515”; and ######
(ii)by inserting “or conditionally approved under section 571 of this Act” after “Public Health Service Act”; and #####
(B)in subparagraph (B), by inserting “conditionally approved under section 571,” after “approved,” each place the term appears; ####
(2)in subsection (b)(4), by striking the second comma after “determination”; ####
(3)in subsection (e)(3)(B), by striking “section 503(b)” and inserting “subsection
(b)or
(f)of section 503 or under section 504”; ####
(4)in subsection (f)(2)— #####
(A)by inserting “, or an animal to which,” after “to a patient to whom”; and #####
(B)by inserting “or by the veterinarian caring for such animal, as applicable” after “attending physician”; ####
(5)in subsection (g)(1), by inserting “conditional approval under section 571,” after “approval,”; ####
(6)in subsection (h)(1), by striking “or section 520(g)”and inserting “512(j), or 520(g)”; and ####
(7)in subsection (k), by striking “section 520(g),”and inserting “512(j), or 520(g)”. ###
(b)New Animal Drugs Section 512(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(a)(1)) is amended— ####
(1)in subparagraph (B), by striking “or” at the end; ####
(2)in subparagraph (C), by striking the period and inserting “; or”; and ####
(3)by inserting after subparagraph
(C)the following: > > ##### “(D) > > there is in effect an authorization pursuant to section 564 with respect to such use or intended use of such drug, and such drug, its labeling, and such use conform to any conditions of such authorization.” > . ###
(c)Emergency Use of Medical Products Section 564A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3a) is amended— ####
(1)in subsection (a)(1)(A), by inserting “, conditionally approved under section 571,” after “chapter”; and ####
(2)in subsection (d), by striking “sections 503(b) and 520(e)” and inserting “subsections
(b)and
(f)of section 503, section 504, and section 520(e)”. ###
(d)Products Held for Emergency Use Section 564B(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3b(2)) is amended— ####
(1)in subparagraph (A)— #####
(A)by inserting “or conditionally approved under section 571 of this Act” after “Public Health Service Act”; and #####
(B)by striking “or 515” and inserting “512, or 515”; and ####
(2)in subparagraph (B), by striking “or 520” and inserting “512, or 520”. ## Subtitle I Vaccine Access, Certainty, and Innovation
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Sec. 3088
CLARIFYING FOOD AND DRUG ADMINISTRATION EMERGENCY USE AUTHORIZATION
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