II 

116TH CONGRESS 

1ST SESSION S. 61 

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 

JANUARY 9, 2019 

Mr. GRASSLEY (for himself and Ms. KLOBUCHAR) 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 2019’’. 

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

7 Chapter VIII of the Federal Food, Drug, and Cos8 metic Act (21 U.S.C. 381 et seq.) is amended by adding 

9 at the end the following: 


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1 ‘‘SEC. 810. IMPORTATION BY INDIVIDUALS OF PRESCRIP2 TION DRUGS FROM CANADA. 

3 ‘‘(a) IN GENERAL.—Notwithstanding any other pro4 vision of this Act, not later than 180 days after the date 

5 of enactment of this section, the Secretary shall promul6 gate regulations permitting individuals to safely import 

7 into the United States a prescription drug described in 

8 subsection (b). 

9 ‘‘(b) PRESCRIPTION DRUG.—A prescription drug de10 scribed in this subsection— 

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

12 ‘‘(A) is purchased from an approved Cana13 dian pharmacy; 

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

15 to practice pharmacy and dispense prescription 

16 drugs in Canada; 

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

18 individual, not for resale, in quantities that do 

19 not exceed a 90-day supply; 

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

21 issued by a physician licensed to practice in a 

22 State in the United States; and 

23 ‘‘(E) has the same active ingredient or in24 gredients, route of administration, dosage form, 

25 and strength as a prescription drug approved 

26 by the Secretary under chapter V; and 


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1 ‘‘(2) does not include— 

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

3 section 102 of the Controlled Substances Act); 

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

5 section 351 of the Public Health Service Act); 

6 ‘‘(C) an infused drug (including a peri7 toneal dialysis solution); 

8 ‘‘(D) an intravenously injected drug; 

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

10 ‘‘(F) a parenteral drug; 

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

12 more biotechnology processes, including— 

13 ‘‘(i) a therapeutic DNA plasmid prod14 uct; 

15 ‘‘(ii) a therapeutic synthetic peptide 

16 product of not more than 40 amino acids; 

17 ‘‘(iii) a monoclonal antibody product 

18 for in vivo use; and 

19 ‘‘(iv) a therapeutic recombinant DNA20 derived product; 

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

22 any time during manufacturing, packing, proc23 essing, or holding; or 

24 ‘‘(I) a photoreactive drug. 

25 ‘‘(c) APPROVED CANADIAN PHARMACY.— 


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1 ‘‘(1) IN GENERAL.—In this section, an ap2 proved Canadian pharmacy is a pharmacy that— 

3 ‘‘(A) is located in Canada; and 

4 ‘‘(B) the Secretary certifies— 

5 ‘‘(i) is licensed to operate and dis6 pense prescription drugs to individuals in 

7 Canada; and 

8 ‘‘(ii) meets the criteria under para9 graph (3). 

10 ‘‘(2) PUBLICATION OF APPROVED CANADIAN

11 PHARMACIES.—The Secretary shall publish on the 

12 internet website of the Food and Drug Administra13 tion a list of approved Canadian pharmacies, includ14 ing the internet website address of each such ap15 proved Canadian pharmacy, from which individuals 

16 may purchase prescription drugs in accordance with 

17 subsection (a). 

18 ‘‘(3) ADDITIONAL CRITERIA.—To be an ap19 proved Canadian pharmacy, the Secretary shall cer20 tify that the pharmacy— 

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

22 at least 5 years preceding the date of such cer23 tification and has a purpose other than to par24 ticipate in the program established under this 

25 section; 


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1 ‘‘(B) operates in accordance with phar2 macy standards set forth by the provincial 

3 pharmacy rules and regulations enacted in Can4 ada; 

5 ‘‘(C) has processes established by the phar6 macy, or participates in another established 

7 process, to certify that the physical premises 

8 and data reporting procedures and licenses are 

9 in compliance with all applicable laws and regu10 lations, and has implemented policies designed 

11 to monitor ongoing compliance with such laws 

12 and regulations; 

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

14 ongoing and comprehensive quality assurance 

15 programs and implements such quality assur16 ance measures, including blind testing, to en17 sure the veracity and reliability of the findings 

18 of the quality assurance program; 

19 ‘‘(E) agrees that laboratories approved by 

20 the Secretary shall be used to conduct product 

21 testing to determine the safety and efficacy of 

22 sample pharmaceutical products; 

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

24 participate in, a process for resolving grievances 


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1 and will be held accountable for violations of es2 tablished guidelines and rules; 

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

4 pharmacies located outside Canada to cus5 tomers in the United States; and 

6 ‘‘(H) meets any other criteria established 

7 by the Secretary.’’. 

Æ 


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