the active ingredient)’’ and inserting ‘‘ac-
tive moiety (as defined by the Secretary in 
section 314.3 of title 21, Code of Federal 
Regulations (or any successor regula-
tions))’’; 
(C) 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))’’; 
(D) in subsection (s), in the matter pre-
ceding paragraph (1), by striking ‘‘active ingre-
dient (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 
(E) in subsection (u)(1), in the matter pre-
ceding subparagraph (A)— 
(i) by striking ‘‘active ingredient (in-
cluding any ester or salt of the active in-
gredient)’’ and inserting ‘‘active moiety (as 
defined by the Secretary in section 314.3 
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of title 21, Code of Federal Regulations (or 
any successor regulations))’’; and 
(ii) by striking ‘‘same active ingre-
dient’’ and inserting ‘‘same active moiety’’; 
(2) 
in 
section 
512(c)(2)(F) 
(21 
U.S.C. 
360b(c)(2)(F))— 
(A) in clause (i), by striking ‘‘active ingre-
dient (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))’’; 
(B) in clause (ii), by striking ‘‘active ingre-
dient (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 
(C) in clause (v), by striking ‘‘active ingre-
dient (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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pamtmann on DSKBC07HB2PROD with BILLS
(3) 
in 
section 
524(a)(4)(C) 
(21 
U.S.C. 
360n(a)(4)(C)), by striking ‘‘active ingredient (in-
cluding any ester or salt of the active ingredient)’’ 
and inserting ‘‘active moiety (as defined by the Sec-
retary in section 314.3 of title 21, Code of Federal 
Regulations (or any successor regulations))’’; 
(4) 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 Sec-
retary in section 314.3 of title 21, Code of Federal 
Regulations (or any successor regulations))’’; and 
(5) 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 Sec-
retary in section 314.3 of title 21, Code of Federal 
Regulations (or any successor regulations))’’. 
Æ 
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