II
119THCONGRESS
1
STSESSION S. 641
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
FEBRUARY19, 2025
Ms. K
LOBUCHAR(for herself, Mr. GRASSLEY, Ms. BALDWIN, Mr. KING, Mr.
M
ERKLEY, Mrs. SHAHEEN, Mr. WHITEHOUSE, and Mr. WELCH) intro-
duced the following bill; which was read twice and referred to the Com-
mittee 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 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 2025’’. 5
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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) I
NGENERAL.—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) P
RESCRIPTIONDRUG.—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
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‘‘(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
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‘‘(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) A
PPROVEDCANADIANPHARMACY.— 5
‘‘(1) I
N GENERAL.—In this section, an ap-6
proved Canadian pharmacy is a pharmacy that— 7
‘‘(A) is physically 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) P
UBLICATION OF APPROVED CANADIAN 15
PHARMACIES.—The Secretary shall publish on the 16
website of the Food and Drug Administration a list 17
of approved Canadian pharmacies, including the 18
website address of each such approved Canadian 19
pharmacy, from which individuals may purchase pre-20
scription drugs in accordance with subsection (a). 21
‘‘(3) A
DDITIONAL CRITERIA.—To be an ap-22
proved Canadian pharmacy, the Secretary shall cer-23
tify that the pharmacy— 24
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‘‘(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
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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
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