To allow the importation by individuals of safe and affordable drugs from Canada.

SA 2107. Mr. McCAIN submitted an amendment intended to be proposed by
him to the bill S. 3187, to amend the Federal Food, Drug, and Cosmetic
Act to revise and extend the user-fee programs for prescription drugs
and medical devices, to establish user-fee programs for generic drugs
and biosimilars, and for other purposes; which was ordered to lie on
the table; as follows:

At the end of title XI, add the following:

SEC. 11__. SAFE AND AFFORDABLE DRUGS FROM CANADA.

Chapter VIII of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 381 et seq.), as amended by this Act, is further
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 (other than a controlled
substance, as defined in section 102 of the Controlled
Substances Act) that--
``(1) is purchased from an approved Canadian pharmacy;
``(2) is dispensed by a pharmacist licensed to practice
pharmacy and dispense prescription drugs in Canada;
``(3) is purchased for personal use by the individual, not
for resale, in quantities that do not exceed a 90-day supply;
``(4) is filled using a valid prescription issued by a
physician licensed to practice in the United States; and
``(5) 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.
``(b) 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 subsection (c).
``(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).
``(c) Additional Criteria.--To be an approved Canadian
pharmacy, the Secretary shall certify that the pharmacy--
``(1) has been in existence for a period of at least 5
years preceding the date of enactment of this section and has
a purpose other than to participate in the program
established under this section;
``(2) operates in accordance with pharmacy standards set
forth by the provincial pharmacy rules and regulations
enacted in Canada;
``(3) has processes established by the pharmacy, or
participates in another established process, to certify that
the physical premises

[[Page S3289]]

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;
``(4) 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;
``(5) agrees that laboratories approved by the Secretary
shall be used to conduct product testing to determine the
safety and efficacy of sample pharmaceutical products;
``(6) 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;
``(7) does not resell products from online pharmacies
located outside Canada to customers in the United States; and
``(8) meets any other criteria established by the
Secretary.''.
______