Sec. 3088. Clarifying Food and Drug Administration emergency use authorization
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/bill/114/hr/34/enr/section-3088·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 564 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–3 ) is amended— in subsection (a)(2)— in subparagraph (A)— by striking or 515 and inserting 512, or 515 ; and by inserting or conditionally approved under section 571 of this Act after Public Health Service Act ; and in subparagraph (B), by inserting conditionally approved under section 571, after approved, each place the term appears; in subsection (b)(4), by striking the second comma after determination ; in subsection (e)(3)(B), by striking section 503(b) and inserting subsection
(b)or
(f)of section 503 or under section 504 ; in subsection (f)(2)— by inserting , or an animal to which, after to a patient to whom ; and by inserting or by the veterinarian caring for such animal, as applicable after attending physician ; in subsection (g)(1), by inserting conditional approval under section 571, after approval, ; in subsection (h)(1), by striking or section 520(g) and inserting 512(j), or 520(g) ; and in subsection (k), by striking section 520(g), and inserting 512(j), or 520(g) . Section 512(a)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360b(a)(1) ) is amended— in subparagraph (B), by striking or at the end; in subparagraph (C), by striking the period and inserting ; or ; and by inserting after subparagraph
(C)the following: 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. . Section 564A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–3a ) is amended— in subsection (a)(1)(A), by inserting , conditionally approved under section 571, after chapter ; and 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) . Section 564B(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3b(2)) is amended— in subparagraph (A)— by inserting or conditionally approved under section 571 of this Act after Public Health Service Act ; and by striking or 515 and inserting 512, or 515 ; and in subparagraph (B), by striking or 520 and inserting 512, or 520 .
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U.S. Code
3 references not yet in our index
- 21 USC 360bbb–3
- 21 USC 360bbb–3a
- 21 USC 360bbb–3b(2)
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Sec. 3088
Clarifying Food and Drug Administration emergency use authorization
Cite21 USC 360bbb–3
Cite21 USC 360bbb–3a
Cite21 USC 360bbb–3b(2)
Cites 4Cited by 0 across 0 sources