II 

117TH CONGRESS 

1ST SESSION S. 3401 

To require the Secretary of Health and Human Services to maintain a 

list of the country of origin of all drugs marketed in the United States, 

to ban the use of Federal funds for the purchase of drugs manufactured 

in the People’s Republic of China, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

DECEMBER 15, 2021 

Mr. COTTON (for himself and Mr. BRAUN) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

A BILL 

To require the Secretary of Health and Human Services 

to maintain a list of the country of origin of all drugs 

marketed in the United States, to ban the use of Federal 

funds for the purchase of drugs manufactured in the 

People’s Republic of China, and for other purposes. 

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 ‘‘Anyone But China 

5 Safe Drug Act’’ or the ‘‘ABC Safe Drug Act’’. 


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•S 3401 IS

1 SEC. 2. COUNTRY OF ORIGIN OF DRUGS. 

2 (a) IN GENERAL.—Subchapter A of chapter V of the 

3 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 

4 et seq.) is amended by adding at the end the following: 

5 ‘‘SEC. 524B. REGISTRY OF DRUGS PRODUCED OUTSIDE THE 

6 US. 

7 ‘‘(a) IN GENERAL.—The Secretary shall compile and 

8 maintain a list of all drugs approved under subsection (c) 

9 or (j) of section 505 of this Act or licensed under sub10 section (a) or (k) of section 351 of the Public Health Serv11 ice Act, and any active ingredients in such drugs, that— 

12 ‘‘(1) are manufactured outside of the United 

13 States; and 

14 ‘‘(2) are determined by the Secretary to be crit15 ical to the health and safety of consumers in the 

16 United States. 

17 ‘‘(b) ADDITIONAL LIST.—In conjunction with the list 

18 described in subsection (a), the Secretary shall compile 

19 and maintain a list of drugs included on such list that 

20 are exclusively produced in, or use active or inactive ingre21 dients produced in, the People’s Republic of China. 

22 ‘‘(c) REQUIREMENT.—The list described in sub23 section (a) shall, with respect to each drug included on 

24 the list, provide information about the supply chain of the 

25 drug, including each step in the supply chain that occurs 

26 prior to importation of the drug into the United States.’’. 


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•S 3401 IS

1 (b) FEDERAL HEALTH PROGRAM PURCHASE OF

2 DRUGS.— 

3 (1) IN GENERAL.—Notwithstanding any other 

4 provision of law, with respect to the purchase of a 

5 drug by the Department of Health and Human 

6 Services, the Department of Veterans Affairs, the 

7 Department of Defense, or any other Federal health 

8 care program (as defined in section 1128B(f) of the 

9 Social Security Act (42 U.S.C. 1320a–7b(b))), the 

10 following shall apply: 

11 (A) Beginning on January 1, 2024, such 

12 agency or program may purchase only drugs for 

13 which 60 percent or more of the active pharma14 ceutical ingredients are manufactured in coun15 tries described in paragraph (2). 

16 (B) Beginning on January 1, 2026, such 

17 agency or program may purchase only drugs for 

18 which 100 percent of the active pharmaceutical 

19 ingredients are manufactured in countries de20 scribed in paragraph (2). 

21 (2) COUNTRIES DESCRIBED.—The countries de22 scribed in this paragraph are countries— 

23 (A) other than People’s Republic of China; 

24 and 


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•S 3401 IS

1 (B) that meet the health and safety stand2 ards of the Food and Drug Administration. 

3 (3) WAIVERS.—The Secretary of Health and 

4 Human Services may issue waivers of the require5 ments under paragraph (1) for any agency or pro6 gram that is unable to meet such requirements and 

7 demonstrates a need for the waiver. No waiver may 

8 be issued under this paragraph for drugs that are 

9 purchased on or after January 1, 2027. 

10 (c) LABELING REQUIREMENT.—Section 502 of the 

11 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) 

12 is amended by adding at the end the following: 

13 ‘‘(gg) If it is a drug and its labeling does not specify 

14 the country of origin of each active ingredient contained 

15 in the drug.’’. 

Æ 


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