HB1319 - Relating to wholesale importation of prescription drugs in this state.

      By: Schoolcraft H.B. No. 1319       A BILL TO BE ENTITLED   AN ACT   relating to wholesale importation of prescription drugs in this   state.          BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:   SECTION1. Subtitle A, Title 6, Chapter 444 Health and Safety Code,   is amended as follows:   CHAPTER 444. WHOLESALE PRESCRIPTION DRUG IMPORTATION PROGRAM   Sec. 444.001.  DEFINITIONS.  In this chapter:                (1)  "Canadian supplier" means a manufacturer,   wholesale distributor, or pharmacy that is appropriately licensed   or permitted under Canadian federal or provincial laws and rules to   manufacture, distribute, or dispense prescription drugs.                (2)   "European Union supplier" " means a manufacturer,   wholesale distributor, or pharmacy that is appropriately licensed   or permitted under European Union or laws and rules, or the national   laws and rules of a European Union member nation, to manufacture,   distribute, or dispense prescription drugs.                ( 2 3 )  "Commission" means the Health and Human Services   Commission.                ( 3 4 )  "Prescription drug wholesaler" means a person   licensed as a wholesale distributor under Subchapter N, Chapter   431, that contracts with this state to import prescription drugs   under the program.                ( 4 5 )  "Program" means the wholesale prescription drug   importation program established under this chapter.          Sec. 444.002.  ESTABLISHMENT OF WHOLESALE PRESCRIPTION DRUG   IMPORTATION PROGRAM.  (a)  The commission shall establish the   wholesale prescription drug importation program to provide lower   cost prescription drugs available outside of the United States to   consumers in this state at the lower cost.          (b)  The commission shall implement the program by:                (1)  contracting with one or more prescription drug   wholesalers and Canadian or European Union suppliers to import   prescription drugs and provide prescription drug cost savings to   consumers in this state;                (2)  developing a registration process for health   benefit plan issuers, health care providers, and pharmacies to   obtain and dispense prescription drugs imported under the program;                (3)  developing a list of prescription drugs, including   the prices of those drugs, that meet the requirements of Section   444.003 and publishing the list on the commission's Internet   website;                (4)  establishing an outreach and marketing plan to   generate program awareness;                (5)  establishing and administering a telephone call   center or electronic portal to provide information about the   program;                (6)  ensuring the program and the prescription drug   wholesalers that contract with this state under Subdivision (1)   comply with the tracking, tracing, verification, and   identification requirements of 21 U.S.C. Section 360eee-1;                (7)  prohibiting the distribution, dispensing, or sale   of prescription drugs imported under this chapter outside the   boundaries of this state; and                (8)  performing any other duties the executive   commissioner determines necessary to implement the program.          (c)  The commission shall ensure that the program meets the   requirements of 21 U.S.C. Section 384.          (d)  In developing the program, the commission may consult   with interested parties.          Sec. 444.003.  ELIGIBLE PRESCRIPTION DRUGS. A prescription   drug may be imported into this state under the program only if the   drug:                (1)  meets the United States Food and Drug   Administration's standards related to prescription drug safety,   effectiveness, misbranding, and adulteration;                (2)  does not violate any federal patent laws through   its importation;                (3)  is expected to generate cost savings for   consumers; and                (4)  is not:                      (A)  listed as a controlled substance under state   or federal law;                      (B)  a biological product;                      (C)  an infused drug;                      (D)  an intravenously injected drug;                      (E)  a drug that is inhaled during surgery; or                      (F)  a parenteral drug.          Sec. 444.004.  ANTICOMPETITIVE BEHAVIOR MONITORING.  The   commission, in consultation with the attorney general, shall   identify and monitor any potential anticompetitive activities in   industries affected by the program.          Sec. 444.005.  PROGRAM FUNDING.  In addition to money   appropriated by the legislature, the commission may impose a fee on   each prescription drug sold under the program or establish another   funding method to administer the program.          Sec. 444.006.  AUDIT PROCEDURES. The executive commissioner   by rule shall develop procedures to effectively audit a   prescription drug wholesaler participating in the program.          Sec. 444.007.  ANNUAL REPORTING. Not later than December 1   of each year, the commission shall submit a report to the governor   and the legislature regarding the operation of the program during   the preceding state fiscal year, including:                (1)  which prescription drugs and Canadian or European   Union suppliers are included in the program;                (2)  the number of health benefit plan issuers, health   care providers, and pharmacies participating in the program;                (3)  the number of prescriptions dispensed through the   program;                (4)  the estimated cost savings to consumers, health   plans, employers, and this state since the establishment of the   program and during the preceding state fiscal year;                (5)  information regarding the implementation of the   audit procedures under Section 444.006; and                (6)  any other information:                      (A)  the governor or the legislature requests; or                      (B)  the commission considers necessary.          SECTION 3.  This Act takes effect September 1, 2025.