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.

SA 2884. Mr. McCAIN (for himself and Ms. Klobuchar) submitted an
amendment intended to be proposed to amendment SA 2874 proposed by Mr.
McConnell to the bill H.R. 3762, to provide for reconciliation pursuant
to section 2002 of the concurrent resolution on the budget for fiscal
year 2016;

[[Page S8313]]

which was ordered to lie on the table; as follows:

At the appropriate place, insert the following:

SEC. ___. 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 (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 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 1 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) that 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 Web site of the Food
and Drug Administration a list of approved Canadian
pharmacies, including the Internet Web site 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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