Bill Text: TX HB1319 | 2025-2026 | 89th Legislature | Introduced
Bill Title: Relating to wholesale importation of prescription drugs in this state.
Spectrum: Partisan Bill (Republican 1-0)
Status: (Introduced) 2024-11-14 - Filed [HB1319 Detail]
Download: Texas-2025-HB1319-Introduced.html
By: Schoolcraft | H.B. No. 1319 |
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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. | ||
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Commission. | ||
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licensed as a wholesale distributor under Subchapter N, Chapter | ||
431, that contracts with this state to import prescription drugs | ||
under the program. | ||
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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. |