[Congressional Record Volume 161, Number 174 (Wednesday, December 2, 2015)]
[Senate]
[Pages S8312-S8313]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  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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