Safe and Affordable Drugs from Canada Act of 2021

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 phar- macies 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, 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 2021’’. 5 VerDate Sep 11 2014 23:04 Feb 20, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S259.IS S259 pamtmann on DSKBC07HB2PROD with BILLS 2 •S 259 IS SEC. 2. SAFE AND AFFORDABLE DRUGS FROM CANADA. 1 Chapter VIII of the Federal Food, Drug, and Cos- 2 metic Act (21 U.S.C. 381 et seq.) is amended by adding 3 at the end the following: 4 ‘‘SEC. 810. IMPORTATION BY INDIVIDUALS OF PRESCRIP- 5 TION DRUGS FROM CANADA. 6 ‘‘(a) IN GENERAL.—Notwithstanding any other pro- 7 vision of this Act, not later than 180 days after the date 8 of enactment of this section, the Secretary shall promul- 9 gate regulations permitting individuals to safely import 10 into the United States a prescription drug described in 11 subsection (b). 12 ‘‘(b) PRESCRIPTION DRUG.—A prescription drug de- 13 scribed in this subsection— 14 ‘‘(1) is a prescription drug that— 15 ‘‘(A) is purchased from an approved Cana- 16 dian pharmacy; 17 ‘‘(B) is dispensed by a pharmacist licensed 18 to practice pharmacy and dispense prescription 19 drugs in Canada; 20 ‘‘(C) is purchased for personal use by the 21 individual, not for resale, in quantities that do 22 not exceed a 90-day supply; 23 ‘‘(D) is filled using a valid prescription 24 issued by a physician licensed to practice in a 25 State in the United States; and 26 VerDate Sep 11 2014 23:04 Feb 20, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S259.IS S259 pamtmann on DSKBC07HB2PROD with BILLS 3 •S 259 IS ‘‘(E) has the same active ingredient or in- 1 gredients, route of administration, dosage form, 2 and strength as a prescription drug approved 3 by the Secretary under chapter V; and 4 ‘‘(2) does not include— 5 ‘‘(A) a controlled substance (as defined in 6 section 102 of the Controlled Substances Act); 7 ‘‘(B) a biological product (as defined in 8 section 351 of the Public Health Service Act); 9 ‘‘(C) an infused drug (including a peri- 10 toneal dialysis solution); 11 ‘‘(D) an intravenously injected drug; 12 ‘‘(E) a drug that is inhaled during surgery; 13 ‘‘(F) a parenteral drug; 14 ‘‘(G) a drug manufactured through one or 15 more biotechnology processes, including— 16 ‘‘(i) a therapeutic DNA plasmid prod- 17 uct; 18 ‘‘(ii) a therapeutic synthetic peptide 19 product of not more than 40 amino acids; 20 ‘‘(iii) a monoclonal antibody product 21 for in vivo use; and 22 ‘‘(iv) a therapeutic recombinant DNA- 23 derived product; 24 VerDate Sep 11 2014 23:04 Feb 20, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S259.IS S259 pamtmann on DSKBC07HB2PROD with BILLS 4 •S 259 IS ‘‘(H) a drug required to be refrigerated at 1 any time during manufacturing, packing, proc- 2 essing, or holding; or 3 ‘‘(I) a photoreactive drug. 4 ‘‘(c) APPROVED CANADIAN PHARMACY.— 5 ‘‘(1) IN GENERAL.—In this section, an ap- 6 proved Canadian pharmacy is a pharmacy that— 7 ‘‘(A) is located in Canada; and 8 ‘‘(B) the Secretary certifies— 9 ‘‘(i) is licensed to operate and dis- 10 pense prescription drugs to individuals in 11 Canada; and 12 ‘‘(ii) meets the criteria under para- 13 graph (3). 14 ‘‘(2) PUBLICATION OF APPROVED CANADIAN 15 PHARMACIES.—The Secretary shall publish on the 16 internet website of the Food and Drug Administra- 17 tion a list of approved Canadian pharmacies, includ- 18 ing the internet website address of each such ap- 19 proved Canadian pharmacy, from which individuals 20 may purchase prescription drugs in accordance with 21 subsection (a). 22 ‘‘(3) ADDITIONAL CRITERIA.—To be an ap- 23 proved Canadian pharmacy, the Secretary shall cer- 24 tify that the pharmacy— 25 VerDate Sep 11 2014 23:04 Feb 20, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S259.IS S259 pamtmann on DSKBC07HB2PROD with BILLS 5 •S 259 IS ‘‘(A) has been in existence for a period of 1 at least 5 years preceding the date of such cer- 2 tification and has a purpose other than to par- 3 ticipate in the program established under this 4 section; 5 ‘‘(B) operates in accordance with phar- 6 macy standards set forth by the provincial 7 pharmacy rules and regulations enacted in Can- 8 ada; 9 ‘‘(C) has processes established by the phar- 10 macy, or participates in another established 11 process, to certify that the physical premises 12 and data reporting procedures and licenses are 13 in compliance with all applicable laws and regu- 14 lations, and has implemented policies designed 15 to monitor ongoing compliance with such laws 16 and regulations; 17 ‘‘(D) conducts or commits to participate in 18 ongoing and comprehensive quality assurance 19 programs and implements such quality assur- 20 ance measures, including blind testing, to en- 21 sure the veracity and reliability of the findings 22 of the quality assurance program; 23 ‘‘(E) agrees that laboratories approved by 24 the Secretary shall be used to conduct product 25 VerDate Sep 11 2014 23:04 Feb 20, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S259.IS S259 pamtmann on DSKBC07HB2PROD with BILLS 6 •S 259 IS testing to determine the safety and efficacy of 1 sample pharmaceutical products; 2 ‘‘(F) has established, or will establish or 3 participate in, a process for resolving grievances 4 and will be held accountable for violations of es- 5 tablished guidelines and rules; 6 ‘‘(G) does not resell products from online 7 pharmacies located outside Canada to cus- 8 tomers in the United States; and 9 ‘‘(H) meets any other criteria established 10 by the Secretary.’’. 11 Æ VerDate Sep 11 2014 23:04 Feb 20, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6301 E:\BILLS\S259.IS S259 pamtmann on DSKBC07HB2PROD with BILLS