S 641 — Safe and Affordable Drugs from Canada Act of 2025

Summary

Safe and Affordable Drugs from Canada Act of 2025This bill requires the Food and Drug Administration (FDA) to allow for the personal importation of prescription drugs from Canada in certain instances.Such a drug must (1) be purchased from an approved Canadian pharmacy and dispensed by a pharmacist licensed in Canada; (2) be purchased by an individual for personal use only and in quantities not to exceed a 90-day supply; (3) be filled using a valid prescription from a physician licensed in a U.S. state; and (4) have the same active ingredients, route of administration, dosage form, and strength as an FDA-approved drug. Certain types of drugs may not be imported under this program, such as controlled substances, biological products, or intravenously injected drugs.An approved pharmacy under this program must be located and licensed in Canada and meet additional requirements, such as participation in ongoing and comprehensive quality assurance programs.The FDA must publish a list of approved Canadian pharmacies on its website.

Bill Text

• Introduced Introduced in Senate Current html February 19, 2025

Compared against current U.S. Code AI-generated reading aid — verify against the official bill.

The bill allows for the personal importation of prescription drugs from approved Canadian pharmacies, establishing new regulations around this process.

• 21 U.S.C. § 381

  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.

  This adds a new section to allow individuals to import specific prescription drugs from approved Canadian pharmacies under defined conditions.

Action History

1. February 19, 2025

   Introduced in Senate

2. February 19, 2025

   Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Sponsors

• Amy Klobuchar · Primary
• Chuck Grassley · Cosponsor
• Tammy Baldwin · Cosponsor
• King, Angus S., Jr. · Cosponsor
• Jeff Merkley · Cosponsor
• Jeanne Shaheen · Cosponsor
• Sheldon Whitehouse · Cosponsor
• Peter Welch · Cosponsor

Subjects