I 

116TH CONGRESS 

1ST SESSION H. R. 478 

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 HOUSE OF REPRESENTATIVES 

JANUARY 10, 2019 

Ms. PINGREE (for herself and Ms. HERRERA BEUTLER) introduced the 

following bill; which was referred to the Committee on Energy and Commerce 

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 (21 U.S.C. 802)); 

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

6 section 351 of the Public Health Service Act 

7 (42 U.S.C. 262)); 

8 ‘‘(C) an infused drug (including a peri9 toneal dialysis solution); 

10 ‘‘(D) an intravenously injected drug; 

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

12 ‘‘(F) a parenteral drug; 

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

14 more biotechnology processes, including— 

15 ‘‘(i) a therapeutic DNA plasmid prod16 uct; 

17 ‘‘(ii) a therapeutic synthetic peptide 

18 product of not more than 40 amino acids; 

19 ‘‘(iii) a monoclonal antibody product 

20 for in vivo use; and 

21 ‘‘(iv) a therapeutic recombinant DNA22 derived product; 

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

24 any time during manufacturing, packing, proc25 essing, or holding; or 


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1 ‘‘(I) a photoreactive drug. 

2 ‘‘(c) APPROVED CANADIAN PHARMACY.— 

3 ‘‘(1) IN GENERAL.—In this section, an ap4 proved Canadian pharmacy is a pharmacy that— 

5 ‘‘(A) is located in Canada; and 

6 ‘‘(B) that the Secretary certifies— 

7 ‘‘(i) is licensed to operate and dis8 pense prescription drugs to individuals in 

9 Canada; and 

10 ‘‘(ii) meets the criteria under para11 graph (3). 

12 ‘‘(2) PUBLICATION OF APPROVED CANADIAN

13 PHARMACIES.—The Secretary shall publish on the 

14 internet website of the Food and Drug Administra15 tion a list of approved Canadian pharmacies, includ16 ing the internet website address of each such ap17 proved Canadian pharmacy, from which individuals 

18 may purchase prescription drugs in accordance with 

19 subsection (a). 

20 ‘‘(3) ADDITIONAL CRITERIA.—To be an ap21 proved Canadian pharmacy, the Secretary shall cer22 tify that the pharmacy— 

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

24 at least 5 years preceding the date of such cer25 tification and has a purpose other than to parVerDate Sep 11 2014 02:14 Jan 25, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H478.IH H478

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1 ticipate in the program established under this 

2 section; 

3 ‘‘(B) operates in accordance with phar4 macy standards set forth by the provincial 

5 pharmacy rules and regulations enacted in Can6 ada; 

7 ‘‘(C) has processes established by the phar8 macy, or participates in another established 

9 process, to certify that the physical premises 

10 and data reporting procedures and licenses are 

11 in compliance with all applicable laws and regu12 lations, and has implemented policies designed 

13 to monitor ongoing compliance with such laws 

14 and regulations; 

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

16 ongoing and comprehensive quality assurance 

17 programs and implements such quality assur18 ance measures, including blind testing, to en19 sure the veracity and reliability of the findings 

20 of the quality assurance program; 

21 ‘‘(E) agrees that laboratories approved by 

22 the Secretary shall be used to conduct product 

23 testing to determine the safety and efficacy of 

24 sample pharmaceutical products; 


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

2 participate in, a process for resolving grievances 

3 and will be held accountable for violations of es4 tablished guidelines and rules; 

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

6 pharmacies located outside Canada to cus7 tomers in the United States; and 

8 ‘‘(H) meets any other criteria established 

9 by the Secretary.’’. 

Æ 


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