H.B. No. 25
  relating to wholesale importation of prescription drugs in this
  state; authorizing a fee.
         SECTION 1.  This Act may be cited as the Wholesale
  Prescription Drug Importation Act.
         SECTION 2.  Subtitle A, Title 6, Health and Safety Code, is
  amended by adding Chapter 444 to read as follows:
         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)  "Commission" means the Health and Human Services
               (3)  "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)  "Program" means the wholesale prescription drug
  importation program established under this chapter.
  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 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
               (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
               (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
               (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.
  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 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
               (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.  As soon as practicable after the effective date
  of this Act, the executive commissioner of the Health and Human
  Services Commission shall adopt any rules necessary to implement
  Chapter 444, Health and Safety Code, as added by this Act.
         SECTION 4.  If before implementing any provision of this Act
  a state agency determines that a waiver or authorization from a
  federal agency is necessary for implementation of that provision,
  the agency affected by the provision shall request the waiver or
  authorization and may delay implementing that provision until the
  waiver or authorization is granted.
         SECTION 5.  This Act takes effect September 1, 2023.
  ______________________________ ______________________________
     President of the Senate Speaker of the House     
         I certify that H.B. No. 25 was passed by the House on April
  12, 2023, by the following vote:  Yeas 144, Nays 1, 2 present, not
  Chief Clerk of the House   
         I certify that H.B. No. 25 was passed by the Senate on May 22,
  2023, by the following vote:  Yeas 31, Nays 0.
  Secretary of the Senate    
  APPROVED:  _____________________