Bill Summary
The Safe and Affordable Drugs from Canada Act of 2025 is a proposed bill that would amend the Federal Food, Drug, and Cosmetic Act to allow individuals to import safe and affordable prescription drugs from approved pharmacies in Canada. This would be done by adding a new section, 810, to Chapter VIII of the Act. The bill specifies that the Secretary of Health and Human Services must promulgate regulations within 180 days of enactment to allow individuals to import prescription drugs from Canada. These drugs must be purchased from an approved Canadian pharmacy, dispensed by a licensed pharmacist in Canada, and purchased for personal use only (not for resale). The quantity of drugs imported cannot exceed a 90-day supply and must be accompanied by a valid prescription from a licensed physician in the US.
The bill provides a list of drugs that are not eligible for importation, including controlled substances, biological products, infused or injected drugs, and drugs that require refrigeration. The bill also defines an approved Canadian pharmacy as one that is physically located in Canada and certified by the Secretary of Health and Human Services to be licensed and compliant with Canadian pharmacy standards. The Secretary is also required to publish a list of approved Canadian pharmacies on the website of the Food and Drug Administration.
To be an approved Canadian pharmacy, the bill outlines several criteria that must be met, such as being in existence for at least 5 years, operating in accordance with provincial pharmacy standards, and having processes in place to ensure compliance with laws and regulations. The pharmacy must also participate in quality assurance programs and use approved laboratories to test the safety and efficacy of their products. The pharmacy must also have a process for resolving grievances and must not resell products from online pharmacies located outside of Canada.
Overall, this bill aims to provide individuals with access to safe and affordable prescription drugs from Canada by setting guidelines and regulations for importing these drugs.
Possible Impacts
1. The Safe and Affordable Drugs from Canada Act of 2025 could potentially affect individuals who require prescription drugs but cannot afford the high costs of medications in the US. This legislation would allow them to purchase safe and affordable drugs from approved Canadian pharmacies.
2. The Act could also affect individuals who are concerned about the safety and efficacy of prescription drugs. The Act requires approved Canadian pharmacies to conduct comprehensive quality assurance programs and use laboratories approved by the Secretary for product testing, ensuring the safety of the imported drugs.
3. This legislation could also affect individuals who are against importing drugs from other countries, as it allows the importation of prescription drugs from Canada and sets specific criteria for approved Canadian pharmacies. This could spark debates and discussions among the public about the safety and effectiveness of imported drugs.
[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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