Safe and Affordable Prescription Drugs Act of 2015

Summary: Safe and Affordable Prescription Drugs 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 foreign pharmacy that:   is dispensed by a pharmacist licensed in that country;  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 pharmacies in certain foreign countries. Requires HHS to publish a list of approved foreign pharmacies.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Safe and Affordable Prescription 
Drugs Act of 2015''.

SEC. 2. SAFE AND AFFORDABLE PRESCRIPTION DRUGS.

    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.

    ``(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 pharmacy;
                    ``(B) is dispensed by a pharmacist licensed to 
                practice pharmacy and dispense prescription drugs in 
                the country in which the pharmacy is located;
                    ``(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 Pharmacy.--
            ``(1) In general.--In this section, an approved pharmacy is 
        a pharmacy that--
                    ``(A) is located in a country listed or described 
                in section 802(b)(1)(A); and
                    ``(B) the Secretary certifies--
                            ``(i) is licensed to operate and dispense 
                        prescription drugs to individuals in the 
                        country in which such pharmacy is located; and
                            ``(ii) meets the criteria under paragraph 
                        (3).
            ``(2) Publication of approved pharmacies.--The Secretary 
        shall publish on the Internet Web site of the Food and Drug 
        Administration a list of approved pharmacies, including the 
        Internet Web site address of each such approved pharmacy, from 
        which individuals may purchase prescription drugs in accordance 
        with subsection (a).
            ``(3) Additional criteria.--To be an approved 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 pharmacy rules and 
                regulations enacted in the country in which it is 
                located;
                    ``(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 the country in which the 
                pharmacy is located to customers in the United States; 
                and
                    ``(H) meets any other criteria established by the 
                Secretary.''.