[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 259 Introduced in Senate (IS)]
<DOC>
117th CONGRESS
1st Session
S. 259
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 4, 2021
Ms. Klobuchar (for herself, Mr. Grassley, Ms. Baldwin, Ms. Collins, Mr.
Brown, Ms. Hassan, Mr. King, Mr. Leahy, Mr. Merkley, Mrs. Shaheen, Mr.
Whitehouse, and Mr. Wyden) 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 2021''.
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 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 internet website of the Food and
Drug Administration a list of approved Canadian pharmacies,
including the internet 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.''.
<all>