the 117th Congress of the United States

“ SECTION 1. CLARIFYING THE MEANING OF NEW CHEMICAL ENTITY.
(a) In General.—Chapter V of the Federal Food, Drug, and Cosmetic Act is amended—
(1) in section 505 (21 U.S.C. 355) —
(A) in subsection (c) (3) (E) , by striking “active ingredient (including any ester or salt of the active ingredient) ” each place it appears 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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