[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 478 Introduced in House (IH)]

<DOC>






116th CONGRESS
  1st Session
                                H. R. 478

  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.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            January 10, 2019

   Ms. Pingree (for herself and Ms. Herrera Beutler) introduced the 
   following bill; which was referred to the Committee on Energy and 
                                Commerce

_______________________________________________________________________

                                 A BILL


 
  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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Safe and Affordable Drugs from 
Canada Act of 2019''.

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 one 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 website of the Food and 
        Drug Administration a list of approved Canadian pharmacies, 
        including the internet website 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.''.
                                 <all>