H.B. No. 25
AN ACT
relating to wholesale importation of prescription drugs in this
state; authorizing a fee.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
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:
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) "Commission" means the Health and Human Services
Commission.
(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.
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 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 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. 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
voting.
______________________________
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: _____________________
Date
_____________________
Governor