II 

117TH CONGRESS 

1ST SESSION S. 2495 

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 

JULY 28, 2021 

Mr. COTTON (for himself, Mrs. BLACKBURN, Mr. CRUZ, Mr. SCOTT of Florida, and Mr. BRAUN) introduced the following bill; which was read twice 

and referred to the Committee on Finance 

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 ‘‘Protecting our Phar5 maceutical Supply Chain from China Act of 2021’’. 


pamtmann on DSKBC07HB2PROD with BILLS
2 

•S 2495 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.’’. 


pamtmann on DSKBC07HB2PROD with BILLS
3 

•S 2495 IS

1 (b) FEDERAL HEALTH PROGRAM PURCHASE OF

2 DRUGS.— 

3 (1) IN GENERAL.—Notwithstanding any other 

4 provision of law, the Department of Health and 

5 Human Services, the Department of Veterans Af6 fairs, the Department of Defense, and any other 

7 Federal health care program (as defined in section 

8 1128B(f) of the Social Security Act (42 U.S.C. 

9 1320a–7b(b))), with respect to the purchase of a 

10 drug by such agency or program, the following shall 

11 apply: 

12 (A) Beginning on January 1, 2023, such 

13 agency or program may purchase only drugs for 

14 which 60 percent or more of the active pharma15 ceutical ingredients are manufactured in coun16 tries described in paragraph (2). 

17 (B) Beginning on January 1, 2024, such 

18 agency or program may purchase only drugs for 

19 which 100 percent of the active pharmaceutical 

20 ingredients are manufactured in countries de21 scribed in paragraph (2). 

22 (2) COUNTRIES DESCRIBED.—The countries de23 scribed in this paragraph are countries— 

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

25 and 


pamtmann on DSKBC07HB2PROD with BILLS
4 

•S 2495 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, 2026. 

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.’’. 

16 SEC. 3. TEMPORARY 100 PERCENT EXPENSING FOR PHAR17 MACEUTICAL AND MEDICAL DEVICE MANU18 FACTURING PROPERTY. 

19 (a) IN GENERAL.—For purposes of section 168(k) of 

20 the Internal Revenue Code of 1986, in the case of any 

21 qualified pharmaceutical and medical device manufac22 turing property which is placed in service after December 

23 31, 2019, and before January 1, 2027— 

24 (1) such property shall be treated as qualified 

25 property (within the meaning of such section), 


pamtmann on DSKBC07HB2PROD with BILLS
5 

•S 2495 IS

1 (2) the applicable percentage otherwise deter2 mined under section 168(k)(6) of such Code with re3 spect to such property shall be 100 percent, and 

4 (3) paragraph (8) of such section shall not 

5 apply. 

6 (b) QUALIFIED PHARMACEUTICAL AND MEDICAL

7 DEVICE MANUFACTURING PROPERTY.—For purposes of 

8 this section, the term ‘‘qualified pharmaceutical and med9 ical device manufacturing property’’ means any tangible 

10 property placed in service in the United States as part 

11 of the construction or expansion of property for the manu12 facture of drugs (as defined in section 201(g) of the Fed13 eral Food, Drug, and Cosmetic Act (21 U.S.C. 321(g))) 

14 or medical devices (as defined in section 201(h) of such 

15 Act (21 U.S.C. 321(h))). 

Æ 


pamtmann on DSKBC07HB2PROD with BILLS