I 

118TH CONGRESS 

1ST SESSION H. R. 6897 

To require the Secretary of Defense to establish a pilot program to evaluate 

novel pharmaceutical manufacturing technologies to reduce the reliance 

of the Department on foreign manufacturers for active pharmaceutical 

ingredients and key starting materials. 

IN THE HOUSE OF REPRESENTATIVES 

DECEMBER 22, 2023 

Ms. SLOTKIN (for herself and Mr. GALLAGHER) introduced the following bill; 

which was referred to the Committee on Armed Services 

A BILL 

To require the Secretary of Defense to establish a pilot 

program to evaluate novel pharmaceutical manufacturing 

technologies to reduce the reliance of the Department 

on foreign manufacturers for active pharmaceutical ingredients and key starting materials. 

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


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1 SECTION 1. DOMESTIC SYNTHETIC BIOLOGY PHARMA2 CEUTICAL MANUFACTURING PILOT PRO3 GRAM. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Synthetic Biology and Active Pharmaceutical Ingredients 

6 Act’’. 

7 (b) IN GENERAL.—Not later than January 1, 2025, 

8 the Secretary of Defense shall establish a pilot program 

9 to evaluate the use of novel technologies using synthetic 

10 biology to expand domestic manufacturing of covered ac11 tive pharmaceutical ingredients and covered key starting 

12 materials to reduce the reliance of the Department of De13 fense on foreign countries for such covered active pharma14 ceutical ingredients and covered key starting materials. 

15 (c) SUNSET.—The pilot program established under 

16 subsection (a) shall terminate on the date that is three 

17 years after the date of the enactment of this Act. 

18 (d) DEFINITIONS.— 

19 (1) ACTIVE PHARMACEUTICAL INGREDIENT.— 

20 The term ‘‘active pharmaceutical ingredient’’ has the 

21 meaning given such term in section 744A of the 

22 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

23 379j–41). 

24 (2) COVERED ACTIVE PHARMACEUTICAL INGRE25 DIENT.—The term ‘‘covered active pharmaceutical 

26 ingredient’’ means an active pharmaceutical ingreVerDate Sep 11 2014 01:55 Jan 13, 2024 Jkt 049200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H6897.IH H6897

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•HR 6897 IH

1 dient of which a sufficient quantity or quality is not 

2 available from domestic manufacturers to meet the 

3 needs of the Department and which the Secretary 

4 determines to be of strategic importance to the 

5 United States. 

6 (3) COVERED KEY STARTING MATERIAL.—The 

7 term ‘‘covered key starting material’’ means a key 

8 starting material of which a sufficient quantity or 

9 quality is not available from domestic manufacturers 

10 to meet the needs of the Department and which the 

11 Secretary determines to be of strategic importance 

12 to the United States. 

13 (4) KEY STARTING MATERIAL.—The term ‘‘key 

14 starting material’’ means any material that is— 

15 (A) used in the manufacture of an active 

16 pharmaceutical ingredient; and 

17 (B) incorporated as an integral part of the 

18 active pharmaceutical ingredient. 

Æ 


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