I 

116TH CONGRESS 

1ST SESSION H. R. 4955 

To amend the Federal Food, Drug, and Cosmetic Act to clarify the meaning 

of a new chemical entity. 

IN THE HOUSE OF REPRESENTATIVES 

OCTOBER 31, 2019 

Mr. ENGEL (for himself, Mr. GUTHRIE, Mr. SCHRADER, and Mr. HUDSON) 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Protecting Access to 

5 Safe and Effective Medicines Act of 2019’’. 

6 SEC. 2. CLARIFYING THE MEANING OF NEW CHEMICAL EN7 TITY. 

8 Chapter V of the Federal Food, Drug, and Cosmetic 

9 Act is amended— 

10 (1) in section 505 (21 U.S.C. 355)— 


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1 (A) in subsection (c)(3)(E)— 

2 (i) in clause (ii), by striking ‘‘active 

3 ingredient (including any ester or salt of 

4 the active ingredient)’’ and inserting ‘‘ac5 tive moiety (as defined by the Secretary in 

6 section 314.3 of title 21, Code of Federal 

7 Regulations (or any successor regula8 tions))’’; and 

9 (ii) in clause (iii), by striking ‘‘active 

10 ingredient (including any ester or salt of 

11 the active ingredient)’’ and inserting ‘‘ac12 tive moiety (as defined by the Secretary in 

13 section 314.3 of title 21, Code of Federal 

14 Regulations (or any successor regula15 tions))’’; 

16 (B) in subsection (j)(5)(F)— 

17 (i) in clause (ii), by striking ‘‘active 

18 ingredient (including any ester or salt of 

19 the active ingredient)’’ and inserting ‘‘ac20 tive moiety (as defined by the Secretary in 

21 section 314.3 of title 21, Code of Federal 

22 Regulations (or any successor regula23 tions))’’; and 

24 (ii) in clause (iii), by striking ‘‘active 

25 ingredient (including any ester or salt of 


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•HR 4955 IH

1 the active ingredient)’’ and inserting ‘‘ac2 tive moiety (as defined by the Secretary in 

3 section 314.3 of title 21, Code of Federal 

4 Regulations (or any successor regula5 tions))’’; 

6 (C) in subsection (l)(2)(A)(i), by striking 

7 ‘‘active ingredient (including any ester or salt of 

8 the active ingredient)’’ and inserting ‘‘active 

9 moiety (as defined by the Secretary in section 

10 314.3 of title 21, Code of Federal Regulations 

11 (or any successor regulations))’’; 

12 (D) in subsection (s), in the matter pre13 ceding paragraph (1), by striking ‘‘active ingre14 dient (including any ester or salt of the active 

15 ingredient)’’ and inserting ‘‘active moiety (as 

16 defined by the Secretary in section 314.3 of 

17 title 21, Code of Federal Regulations (or any 

18 successor regulations))’’; and 

19 (E) in subsection (u)(1), in the matter pre20 ceding subparagraph (A)— 

21 (i) by striking ‘‘active ingredient (in22 cluding any ester or salt of the active in23 gredient)’’ and inserting ‘‘active moiety (as 

24 defined by the Secretary in section 314.3 


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1 of title 21, Code of Federal Regulations (or 

2 any successor regulations))’’; and 

3 (ii) by striking ‘‘same active ingre4 dient’’ and inserting ‘‘same active moiety’’; 

5 (2) in section 512(c)(2)(F) (21 U.S.C. 

6 360b(c)(2)(F))— 

7 (A) in clause (i), by striking ‘‘active ingre8 dient (including any ester or salt of the active 

9 ingredient)’’ and inserting ‘‘active moiety (as 

10 defined by the Secretary in section 314.3 of 

11 title 21, Code of Federal Regulations (or any 

12 successor regulations))’’; 

13 (B) in clause (ii), by striking ‘‘active ingre14 dient (including any ester or salt of the active 

15 ingredient)’’ and inserting ‘‘active moiety (as 

16 defined by the Secretary in section 314.3 of 

17 title 21, Code of Federal Regulations (or any 

18 successor regulations))’’; and 

19 (C) in clause (v), by striking ‘‘active ingre20 dient (including any ester or salt of the active 

21 ingredient)’’ and inserting ‘‘active moiety (as 

22 defined by the Secretary in section 314.3 of 

23 title 21, Code of Federal Regulations (or any 

24 successor regulations))’’; 


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1 (3) in section 524(a)(4)(C) (21 U.S.C. 

2 360n(a)(4)(C)), by striking ‘‘active ingredient (in3 cluding any ester or salt of the active ingredient)’’ 

4 and inserting ‘‘active moiety (as defined by the Sec5 retary in section 314.3 of title 21, Code of Federal 

6 Regulations (or any successor regulations))’’; 

7 (4) in section 529(a)(4)(A)(ii) (21 U.S.C. 

8 360ff(a)(4)(A)(ii)), by striking ‘‘active ingredient 

9 (including any ester or salt of the active ingredient)’’ 

10 and inserting ‘‘active moiety (as defined by the Sec11 retary in section 314.3 of title 21, Code of Federal 

12 Regulations (or any successor regulations))’’; and 

13 (5) in section 565A(a)(4)(D) (21 U.S.C. 

14 360bbb–4a(a)(4)(D)), by striking ‘‘active ingredient 

15 (including any ester or salt of the active ingredient)’’ 

16 and inserting ‘‘active moiety (as defined by the Sec17 retary in section 314.3 of title 21, Code of Federal 

18 Regulations (or any successor regulations))’’. 

Æ 


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