I 
116TH CONGRESS 
1ST SESSION 
H. R. 478 
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 HOUSE OF REPRESENTATIVES 
JANUARY 10, 2019 
Ms. PINGREE (for herself and Ms. HERRERA BEUTLER) introduced the 
following bill; which was referred to the Committee on Energy and Commerce 
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-
tives 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 2019’’. 
SEC. 2. SAFE AND AFFORDABLE DRUGS FROM CANADA. 
Chapter VIII of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 381 et seq.) is amended by adding 
at the end the following: 
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‘‘SEC. 810. IMPORTATION BY INDIVIDUALS OF PRESCRIP-
TION DRUGS FROM CANADA. 
‘‘(a) IN GENERAL.—Notwithstanding any other pro-
vision of this Act, not later than 180 days after the date 
of enactment of this section, the Secretary shall promul-
gate regulations permitting individuals to safely import 
into the United States a prescription drug described in 
subsection (b). 
‘‘(b) PRESCRIPTION DRUG.—A prescription drug de-
scribed in this subsection— 
‘‘(1) is a prescription drug that— 
‘‘(A) is purchased from an approved Cana-
dian 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 in-
gredients, route of administration, dosage form, 
and strength as a prescription drug approved 
by the Secretary under chapter V; and 
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‘‘(2) does not include— 
‘‘(A) a controlled substance (as defined in 
section 102 of the Controlled Substances Act 
(21 U.S.C. 802)); 
‘‘(B) a biological product (as defined in 
section 351 of the Public Health Service Act 
(42 U.S.C. 262)); 
‘‘(C) an infused drug (including a peri-
toneal 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 prod-
uct; 
‘‘(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, proc-
essing, or holding; or 
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‘‘(I) a photoreactive drug. 
‘‘(c) APPROVED CANADIAN PHARMACY.— 
‘‘(1) IN
GENERAL.—In this section, an ap-
proved Canadian pharmacy is a pharmacy that— 
‘‘(A) is located in Canada; and 
‘‘(B) that the Secretary certifies— 
‘‘(i) is licensed to operate and dis-
pense prescription drugs to individuals in 
Canada; and 
‘‘(ii) meets the criteria under para-
graph (3). 
‘‘(2) PUBLICATION
OF
APPROVED
CANADIAN 
PHARMACIES.—The Secretary shall publish on the 
internet website of the Food and Drug Administra-
tion a list of approved Canadian pharmacies, includ-
ing the internet website address of each such ap-
proved Canadian pharmacy, from which individuals 
may purchase prescription drugs in accordance with 
subsection (a). 
‘‘(3) ADDITIONAL
CRITERIA.—To be an ap-
proved Canadian pharmacy, the Secretary shall cer-
tify that the pharmacy— 
‘‘(A) has been in existence for a period of 
at least 5 years preceding the date of such cer-
tification and has a purpose other than to par-
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ticipate in the program established under this 
section; 
‘‘(B) operates in accordance with phar-
macy standards set forth by the provincial 
pharmacy rules and regulations enacted in Can-
ada; 
‘‘(C) has processes established by the phar-
macy, 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 regu-
lations, 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 assur-
ance measures, including blind testing, to en-
sure 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; 
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‘‘(F) has established, or will establish or 
participate in, a process for resolving grievances 
and will be held accountable for violations of es-
tablished guidelines and rules; 
‘‘(G) does not resell products from online 
pharmacies located outside Canada to cus-
tomers in the United States; and 
‘‘(H) meets any other criteria established 
by the Secretary.’’. 
Æ 
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