Safe and Affordable Drugs from Canada Act of 2019

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 phar- macies 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, Edu- cation, 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. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Safe and Affordable 4 Drugs from Canada Act of 2019’’. 5 SEC. 2. SAFE AND AFFORDABLE DRUGS FROM CANADA. 6 Chapter VIII of the Federal Food, Drug, and Cos- 7 metic Act (21 U.S.C. 381 et seq.) is amended by adding 8 at the end the following: 9 VerDate Sep 11 2014 01:19 Jan 16, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S61.IS S61 pamtmann on DSKBFK8HB2PROD with BILLS 2 •S 61 IS ‘‘SEC. 810. IMPORTATION BY INDIVIDUALS OF PRESCRIP- 1 TION DRUGS FROM CANADA. 2 ‘‘(a) IN GENERAL.—Notwithstanding any other pro- 3 vision of this Act, not later than 180 days after the date 4 of enactment of this section, the Secretary shall promul- 5 gate regulations permitting individuals to safely import 6 into the United States a prescription drug described in 7 subsection (b). 8 ‘‘(b) PRESCRIPTION DRUG.—A prescription drug de- 9 scribed in this subsection— 10 ‘‘(1) is a prescription drug that— 11 ‘‘(A) is purchased from an approved Cana- 12 dian pharmacy; 13 ‘‘(B) is dispensed by a pharmacist licensed 14 to practice pharmacy and dispense prescription 15 drugs in Canada; 16 ‘‘(C) is purchased for personal use by the 17 individual, not for resale, in quantities that do 18 not exceed a 90-day supply; 19 ‘‘(D) is filled using a valid prescription 20 issued by a physician licensed to practice in a 21 State in the United States; and 22 ‘‘(E) has the same active ingredient or in- 23 gredients, route of administration, dosage form, 24 and strength as a prescription drug approved 25 by the Secretary under chapter V; and 26 VerDate Sep 11 2014 01:19 Jan 16, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S61.IS S61 pamtmann on DSKBFK8HB2PROD with BILLS 3 •S 61 IS ‘‘(2) does not include— 1 ‘‘(A) a controlled substance (as defined in 2 section 102 of the Controlled Substances Act); 3 ‘‘(B) a biological product (as defined in 4 section 351 of the Public Health Service Act); 5 ‘‘(C) an infused drug (including a peri- 6 toneal dialysis solution); 7 ‘‘(D) an intravenously injected drug; 8 ‘‘(E) a drug that is inhaled during surgery; 9 ‘‘(F) a parenteral drug; 10 ‘‘(G) a drug manufactured through one or 11 more biotechnology processes, including— 12 ‘‘(i) a therapeutic DNA plasmid prod- 13 uct; 14 ‘‘(ii) a therapeutic synthetic peptide 15 product of not more than 40 amino acids; 16 ‘‘(iii) a monoclonal antibody product 17 for in vivo use; and 18 ‘‘(iv) a therapeutic recombinant DNA- 19 derived product; 20 ‘‘(H) a drug required to be refrigerated at 21 any time during manufacturing, packing, proc- 22 essing, or holding; or 23 ‘‘(I) a photoreactive drug. 24 ‘‘(c) APPROVED CANADIAN PHARMACY.— 25 VerDate Sep 11 2014 01:19 Jan 16, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S61.IS S61 pamtmann on DSKBFK8HB2PROD with BILLS 4 •S 61 IS ‘‘(1) IN GENERAL.—In this section, an ap- 1 proved Canadian pharmacy is a pharmacy that— 2 ‘‘(A) is located in Canada; and 3 ‘‘(B) the Secretary certifies— 4 ‘‘(i) is licensed to operate and dis- 5 pense prescription drugs to individuals in 6 Canada; and 7 ‘‘(ii) meets the criteria under para- 8 graph (3). 9 ‘‘(2) PUBLICATION OF APPROVED CANADIAN 10 PHARMACIES.—The Secretary shall publish on the 11 internet website of the Food and Drug Administra- 12 tion a list of approved Canadian pharmacies, includ- 13 ing the internet website address of each such ap- 14 proved Canadian pharmacy, from which individuals 15 may purchase prescription drugs in accordance with 16 subsection (a). 17 ‘‘(3) ADDITIONAL CRITERIA.—To be an ap- 18 proved Canadian pharmacy, the Secretary shall cer- 19 tify that the pharmacy— 20 ‘‘(A) has been in existence for a period of 21 at least 5 years preceding the date of such cer- 22 tification and has a purpose other than to par- 23 ticipate in the program established under this 24 section; 25 VerDate Sep 11 2014 01:19 Jan 16, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S61.IS S61 pamtmann on DSKBFK8HB2PROD with BILLS 5 •S 61 IS ‘‘(B) operates in accordance with phar- 1 macy standards set forth by the provincial 2 pharmacy rules and regulations enacted in Can- 3 ada; 4 ‘‘(C) has processes established by the phar- 5 macy, or participates in another established 6 process, to certify that the physical premises 7 and data reporting procedures and licenses are 8 in compliance with all applicable laws and regu- 9 lations, and has implemented policies designed 10 to monitor ongoing compliance with such laws 11 and regulations; 12 ‘‘(D) conducts or commits to participate in 13 ongoing and comprehensive quality assurance 14 programs and implements such quality assur- 15 ance measures, including blind testing, to en- 16 sure the veracity and reliability of the findings 17 of the quality assurance program; 18 ‘‘(E) agrees that laboratories approved by 19 the Secretary shall be used to conduct product 20 testing to determine the safety and efficacy of 21 sample pharmaceutical products; 22 ‘‘(F) has established, or will establish or 23 participate in, a process for resolving grievances 24 VerDate Sep 11 2014 01:19 Jan 16, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S61.IS S61 pamtmann on DSKBFK8HB2PROD with BILLS 6 •S 61 IS and will be held accountable for violations of es- 1 tablished guidelines and rules; 2 ‘‘(G) does not resell products from online 3 pharmacies located outside Canada to cus- 4 tomers in the United States; and 5 ‘‘(H) meets any other criteria established 6 by the Secretary.’’. 7 Æ VerDate Sep 11 2014 01:19 Jan 16, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6301 E:\BILLS\S61.IS S61 pamtmann on DSKBFK8HB2PROD with BILLS