II 

117TH CONGRESS 

1ST SESSION S. 259 

To amend the Federal Food, Drug, and Cosmetic Act to allow for the 

personal importation of safe and affordable drugs from approved pharmacies in Canada. 

IN THE SENATE OF THE UNITED STATES 

FEBRUARY 4, 2021 

Ms. KLOBUCHAR (for herself, Mr. GRASSLEY, Ms. BALDWIN, Ms. COLLINS, 

Mr. BROWN, Ms. HASSAN, Mr. KING, Mr. LEAHY, Mr. MERKLEY, Mrs. 

SHAHEEN, Mr. WHITEHOUSE, and Mr. WYDEN) introduced the following 

bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

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

allow for the personal importation of safe and affordable 

drugs from approved pharmacies in Canada. 

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 ‘‘Safe and Affordable 

5 Drugs from Canada Act of 2021’’. 


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1 SEC. 2. SAFE AND AFFORDABLE DRUGS FROM CANADA. 

2 Chapter VIII of the Federal Food, Drug, and Cos3 metic Act (21 U.S.C. 381 et seq.) is amended by adding 

4 at the end the following: 

5 ‘‘SEC. 810. IMPORTATION BY INDIVIDUALS OF PRESCRIP6 TION DRUGS FROM CANADA. 

7 ‘‘(a) IN GENERAL.—Notwithstanding any other pro8 vision of this Act, not later than 180 days after the date 

9 of enactment of this section, the Secretary shall promul10 gate regulations permitting individuals to safely import 

11 into the United States a prescription drug described in 

12 subsection (b). 

13 ‘‘(b) PRESCRIPTION DRUG.—A prescription drug de14 scribed in this subsection— 

15 ‘‘(1) is a prescription drug that— 

16 ‘‘(A) is purchased from an approved Cana17 dian pharmacy; 

18 ‘‘(B) is dispensed by a pharmacist licensed 

19 to practice pharmacy and dispense prescription 

20 drugs in Canada; 

21 ‘‘(C) is purchased for personal use by the 

22 individual, not for resale, in quantities that do 

23 not exceed a 90-day supply; 

24 ‘‘(D) is filled using a valid prescription 

25 issued by a physician licensed to practice in a 

26 State in the United States; and 


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1 ‘‘(E) has the same active ingredient or in2 gredients, route of administration, dosage form, 

3 and strength as a prescription drug approved 

4 by the Secretary under chapter V; and 

5 ‘‘(2) does not include— 

6 ‘‘(A) a controlled substance (as defined in 

7 section 102 of the Controlled Substances Act); 

8 ‘‘(B) a biological product (as defined in 

9 section 351 of the Public Health Service Act); 

10 ‘‘(C) an infused drug (including a peri11 toneal dialysis solution); 

12 ‘‘(D) an intravenously injected drug; 

13 ‘‘(E) a drug that is inhaled during surgery; 

14 ‘‘(F) a parenteral drug; 

15 ‘‘(G) a drug manufactured through one or 

16 more biotechnology processes, including— 

17 ‘‘(i) a therapeutic DNA plasmid prod18 uct; 

19 ‘‘(ii) a therapeutic synthetic peptide 

20 product of not more than 40 amino acids; 

21 ‘‘(iii) a monoclonal antibody product 

22 for in vivo use; and 

23 ‘‘(iv) a therapeutic recombinant DNA24 derived product; 


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1 ‘‘(H) a drug required to be refrigerated at 

2 any time during manufacturing, packing, proc3 essing, or holding; or 

4 ‘‘(I) a photoreactive drug. 

5 ‘‘(c) APPROVED CANADIAN PHARMACY.— 

6 ‘‘(1) IN GENERAL.—In this section, an ap7 proved Canadian pharmacy is a pharmacy that— 

8 ‘‘(A) is located in Canada; and 

9 ‘‘(B) the Secretary certifies— 

10 ‘‘(i) is licensed to operate and dis11 pense prescription drugs to individuals in 

12 Canada; and 

13 ‘‘(ii) meets the criteria under para14 graph (3). 

15 ‘‘(2) PUBLICATION OF APPROVED CANADIAN

16 PHARMACIES.—The Secretary shall publish on the 

17 internet website of the Food and Drug Administra18 tion a list of approved Canadian pharmacies, includ19 ing the internet website address of each such ap20 proved Canadian pharmacy, from which individuals 

21 may purchase prescription drugs in accordance with 

22 subsection (a). 

23 ‘‘(3) ADDITIONAL CRITERIA.—To be an ap24 proved Canadian pharmacy, the Secretary shall cer25 tify that the pharmacy— 


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1 ‘‘(A) has been in existence for a period of 

2 at least 5 years preceding the date of such cer3 tification and has a purpose other than to par4 ticipate in the program established under this 

5 section; 

6 ‘‘(B) operates in accordance with phar7 macy standards set forth by the provincial 

8 pharmacy rules and regulations enacted in Can9 ada; 

10 ‘‘(C) has processes established by the phar11 macy, or participates in another established 

12 process, to certify that the physical premises 

13 and data reporting procedures and licenses are 

14 in compliance with all applicable laws and regu15 lations, and has implemented policies designed 

16 to monitor ongoing compliance with such laws 

17 and regulations; 

18 ‘‘(D) conducts or commits to participate in 

19 ongoing and comprehensive quality assurance 

20 programs and implements such quality assur21 ance measures, including blind testing, to en22 sure the veracity and reliability of the findings 

23 of the quality assurance program; 

24 ‘‘(E) agrees that laboratories approved by 

25 the Secretary shall be used to conduct product 


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1 testing to determine the safety and efficacy of 

2 sample pharmaceutical products; 

3 ‘‘(F) has established, or will establish or 

4 participate in, a process for resolving grievances 

5 and will be held accountable for violations of es6 tablished guidelines and rules; 

7 ‘‘(G) does not resell products from online 

8 pharmacies located outside Canada to cus9 tomers in the United States; and 

10 ‘‘(H) meets any other criteria established 

11 by the Secretary.’’. 

Æ 


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