text: SECTION 1. SHORT TITLE.
  
      This Act may be cited as the ``Safe and Affordable Drugs from 
  Canada Act of 2015''.
  
  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 (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.''.
target: Safe and Affordable Drugs from Canada Act of 2015 Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require the Department of Health and Human Services (HHS) to promulgate regulations within 180 days permitting individuals to import a prescription drug purchased from an approved Canadian pharmacy that:   is dispensed by a pharmacist licensed in Canada;  is purchased for personal use in quantities not greater than a 90-day supply; is filled using a valid prescription issued by a physician licensed to practice in the United States; and has the same active ingredient or ingredients, route of administration, dosage form, and strength as a prescription drug approved under the FFDCA.   Sets forth exceptions, including for controlled substances and biological products.  Establishes a certification process for approving Canadian pharmacies. Requires HHS to publish a list of approved Canadian pharmacies.
feat_title: Safe and Affordable Drugs from Canada Act of 2015