I
117th CONGRESS
1st Session
H. R. 1857
IN THE HOUSE OF REPRESENTATIVES
March 11, 2021
Mr. Schrader (for himself and Mr. Guthrie) introduced the following bill; which was referred to the Committee on Energy and Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to clarify the meaning of a new chemical entity.
Short title
This Act may be cited as the Protecting Access to Safe and Effective Medicines Act of 2021
.
Clarifying the meaning of new chemical entity
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))
.