119-s641

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 641 Introduced in Senate

    (IS) ]

<DOC>

119th CONGRESS
 1st Session
 S. 641

 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 19, 2025

 Ms. Klobuchar (for herself, Mr. Grassley, Ms. Baldwin, Mr. King, Mr. 
 Merkley, Mrs. Shaheen, Mr. Whitehouse, and Mr. Welch) 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.

 Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

 This Act may be cited as the ``Safe and Affordable Drugs from 
Canada Act of 2025''.

SEC. 2. SAFE AND AFFORDABLE DRUGS FROM CANADA.

 Chapter VIII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
381 et seq.) is amended by adding at the end the following:

``

SEC. 810. IMPORTATION BY INDIVIDUALS OF PRESCRIPTION DRUGS FROM 
 CANADA.

 ``

    (a) In General.--Notwithstanding any other provision of this Act, 
not later than 180 days after the date of enactment of this section, 
the Secretary shall promulgate regulations permitting individuals to 
safely import into the United States a prescription drug described in 
subsection

    (b) .
 ``

    (b) Prescription Drug.--A prescription drug described in this 
subsection--
 ``

    (1) is a prescription drug that--
 ``
        (A) is purchased from an approved Canadian 
 pharmacy;
 ``
        (B) is dispensed by a pharmacist licensed to 
 practice pharmacy and dispense prescription drugs in 
 Canada;
 ``
            (C) is purchased for personal use by the 
 individual, not for resale, in quantities that do not 
 exceed a 90-day supply;
 ``
            (D) is filled using a valid prescription issued 
 by a physician licensed to practice in a State in the 
 United States; and
 ``
        (E) has the same active ingredient or 
 ingredients, route of administration, dosage form, and 
 strength as a prescription drug approved by the 
 Secretary under chapter V; and
 ``

    (2) does not include--
 ``
        (A) a controlled substance (as defined in 

section 102 of the Controlled Substances Act);
 ``
        (B) a biological product (as defined in 

section 351 of the Public Health Service Act);
 ``
            (C) an infused drug (including a peritoneal 
 dialysis solution);
 ``
            (D) an intravenously injected drug;
 ``
        (E) a drug that is inhaled during surgery;
 ``
        (F) a parenteral drug;
 ``
        (G) a drug manufactured through one or more 
 biotechnology processes, including--
 ``
            (i) a therapeutic DNA plasmid product;
 ``
            (ii) a therapeutic synthetic peptide 
 product of not more than 40 amino acids;
 ``
            (iii) a monoclonal antibody product for 
 in vivo use; and
 ``
            (iv) a therapeutic recombinant DNA-
 derived product;
 ``
        (H) a drug required to be refrigerated at any 
 time during manufacturing, packing, processing, or 
 holding; or
 ``
            (I) a photoreactive drug.
 ``
            (c) Approved Canadian Pharmacy.--
 ``

    (1) In general.--In this section, an approved Canadian 
 pharmacy is a pharmacy that--
 ``
        (A) is physically located in Canada; and
 ``
        (B) the Secretary certifies--
 ``
            (i) is licensed to operate and dispense 
 prescription drugs to individuals in Canada; 
 and
 ``
            (ii) meets the criteria under paragraph

    (3) .
 ``

    (2) Publication of approved canadian pharmacies.--The 
 Secretary shall publish on the website of the Food and Drug 
 Administration a list of approved Canadian pharmacies, 
 including the website address of each such approved Canadian 
 pharmacy, from which individuals may purchase prescription 
 drugs in accordance with subsection

    (a) .
 ``

    (3) Additional criteria.--To be an approved Canadian 
 pharmacy, the Secretary shall certify that the pharmacy--
 ``
        (A) has been in existence for a period of at 
 least 5 years preceding the date of such certification 
 and has a purpose other than to participate in the 
 program established under this section;
 ``
        (B) operates in accordance with pharmacy 
 standards set forth by the provincial pharmacy rules 
 and regulations enacted in Canada;
 ``
            (C) has processes established by the pharmacy, or 
 participates in another established process, to certify 
 that the physical premises and data reporting 
 procedures and licenses are in compliance with all 
 applicable laws and regulations, and has implemented 
 policies designed to monitor ongoing compliance with 
 such laws and regulations;
 ``
            (D) conducts or commits to participate in ongoing 
 and comprehensive quality assurance programs and 
 implements such quality assurance measures, including 
 blind testing, to ensure the veracity and reliability 
 of the findings of the quality assurance program;
 ``
        (E) agrees that laboratories approved by the 
 Secretary shall be used to conduct product testing to 
 determine the safety and efficacy of sample 
 pharmaceutical products;
 ``
        (F) has established, or will establish or 
 participate in, a process for resolving grievances and 
 will be held accountable for violations of established 
 guidelines and rules;
 ``
        (G) does not resell products from online 
 pharmacies located outside Canada to customers in the 
 United States; and
 ``
        (H) meets any other criteria established by the 
 Secretary.''.
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