Sec. 331. Clarifying the meaning of new chemical entity
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Chapter V of the Federal Food, Drug, and Cosmetic Act is amended— in section 505 ( 21 U.S.C. 355 )— in subsection (c)(3)(E)— in clause (ii), by striking active ingredient (including any ester or salt of the active ingredient) and inserting active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) ; and in clause (iii), by striking active ingredient (including any ester or salt of the active ingredient) and inserting active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) ; in subsection (j)(5)(F)— in clause (ii), by striking active ingredient (including any ester or salt of the active ingredient) and inserting active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) ; and in clause (iii), by striking active ingredient (including any ester or salt of the active ingredient) and inserting active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) ; in subsection (l)(2)(A)(i), by striking active ingredient (including any ester or salt of the active ingredient) and inserting active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) ; in subsection (s), in the matter preceding paragraph (1), by striking active ingredient (including any ester or salt of the active ingredient) and inserting active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) ; and in subsection (u)(1), in the matter preceding subparagraph (A)— by striking active ingredient (including any ester or salt of the active ingredient) and inserting active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) ; and by striking same active ingredient and inserting same active moiety ; in section 512(c)(2)(F) ( 21 U.S.C. 360b(c)(2)(F) )— in clause (i), by striking active ingredient (including any ester or salt of the active ingredient) and inserting active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) ; in clause (ii), by striking active ingredient (including any ester or salt of the active ingredient) and inserting active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) ; and in clause (v), by striking active ingredient (including any ester or salt of the active ingredient) and inserting active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) ; in section 524(a)(4)(C) ( 21 U.S.C. 360n(a)(4)(C) ), by striking active ingredient (including any ester or salt of the active ingredient) and inserting active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) ; in section 529(a)(4)(A)(ii) ( 21 U.S.C. 360ff(a)(4)(A)(ii) ), by striking active ingredient (including any ester or salt of the active ingredient) and inserting active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) ; and in section 565A(a)(4)(D) (21 U.S.C. 360bbb–4a(a)(4)(D)), by striking active ingredient (including any ester or salt of the active ingredient) and inserting active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) .
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- 21 USC 360bbb–4a(a)(4)(D)
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Sec. 331
Clarifying the meaning of new chemical entity
Cite21 USC 360bbb–4a(a)(4)(D)
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