Bill Text: TX HB25 | 2023-2024 | 88th Legislature | Introduced
NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Relating to wholesale importation of prescription drugs in this state; authorizing a fee.
Spectrum: Bipartisan Bill
Status: (Passed) 2023-06-12 - Effective on 9/1/23 [HB25 Detail]
Download: Texas-2023-HB25-Introduced.html
Bill Title: Relating to wholesale importation of prescription drugs in this state; authorizing a fee.
Spectrum: Bipartisan Bill
Status: (Passed) 2023-06-12 - Effective on 9/1/23 [HB25 Detail]
Download: Texas-2023-HB25-Introduced.html
By: Talarico | H.B. No. 25 |
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relating to wholesale importation of prescription drugs for resale | ||
to Texas residents. | ||
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: | ||
SECTION 1. SHORT TITLE. This Act shall be known as the | ||
"Wholesale Prescription Drug Importation Act." | ||
SECTION 2. WHOLESALE PRESCRIPTION DRUG IMPORTATION | ||
PROGRAM. Subtitle C, Title 2, Health and Safety Code is amended by | ||
adding Chapter 66 to read as follows: | ||
CHAPTER 66. WHOLESALE PRESCRIPTION DRUG IMPORTATION PROGRAM | ||
SUBCHAPTER A. GENERAL PROVISIONS. | ||
Sec. 66.001. 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 Health and Human Services | ||
Commission. | ||
(3) "Eligible prescription drug" means a drug eligible for | ||
importation that: | ||
(a) meets the United States federal food and drug | ||
administration's standards related to safety, effectiveness, | ||
misbranding and adulteration; | ||
(b) does not violate federal patent laws; | ||
(c) is expected to generate cost savings; and | ||
(d) is not a controlled substance; | ||
(4) "Program" means the wholesale prescription drug | ||
importation program; and | ||
(5) "State drug wholesaler" means a licensed wholesale drug | ||
distributor that contracts with the state to import eligible | ||
prescription drugs from a Canadian supplier. | ||
Sec. 66.002. CONSTRUCTION OF CHAPTER; PURPOSE. (a) The | ||
purpose of this chapter is to establish a program to make | ||
prescription drugs that are available at lower costs outside the | ||
United States available to consumers in Texas at those lower costs. | ||
Sec. 66.003. ESTABLISHMENT OF WHOLESALE PRESCRIPTION DRUG | ||
IMPORTATION PROGRAM. (a) The commission shall design a "wholesale | ||
prescription drug importation program" that complies with the | ||
applicable requirements of 21 U.S.C. Section 384, including the | ||
requirements regarding safety and cost savings. The commission | ||
shall explore all potential mechanisms, to the extent allowable | ||
under law, for the importation of eligible prescription drugs. The | ||
program design shall: | ||
(1) contract with one or more state drug wholesalers | ||
to seek federal certification and approval to import safe, eligible | ||
prescription drugs from Canadian suppliers and provide significant | ||
prescription drug cost savings to Texas consumers; | ||
(2) allow the importation of eligible prescription | ||
drugs sold by Canadian suppliers; | ||
(3) ensure that only eligible prescription drugs | ||
meeting the United States food and drug administration's safety, | ||
effectiveness and other standards are imported by or on behalf of | ||
the state; | ||
(4) import only those eligible prescription drugs | ||
expected to generate substantial savings for Texas consumers; | ||
(5) ensure that, with respect to eligible prescription | ||
drugs to be imported pursuant to the program, the program and the | ||
state drug wholesaler comply with the tracking, tracing, | ||
verification and identification requirements of 21 U.S.C. Sections | ||
360eee and 360eee-1; | ||
(6) prohibit the distribution, dispensing or sale of | ||
eligible prescription drugs imported pursuant to the Wholesale | ||
Prescription Drug Importation Act outside the exterior boundaries | ||
of the state; | ||
(7) recommend a charge per prescription or another | ||
method of support to ensure that the program is funded adequately in | ||
a manner that does not jeopardize significant consumer savings; and | ||
(8) include an audit function. | ||
Sec. 66.004. MONITORING FOR ANTI-COMPETITIVE | ||
BEHAVIOR. (a) The commission shall consult with the attorney | ||
general to identify the potential, and to monitor, for | ||
anti-competitive behavior in industries that would be affected by | ||
the program. | ||
Sec. 66.005. FEDERAL COMPLIANCE. (a) The commission shall | ||
submit a formal request to the secretary of the United States | ||
department of health and human services for certification of the | ||
state's program. | ||
Sec. 66.006. IMPLEMENTATION. (a) Upon certification of | ||
approval by the secretary of the United States department of health | ||
and human services, the commission shall begin implementing the | ||
program and begin operating the program within six months of that | ||
approval. As part of the implementation process, the commission | ||
shall: | ||
(1) enter into contracts in accordance with the | ||
Procurement Code with one or more state drug wholesalers and Texas | ||
licensed drug distributors and contract with one or more approved | ||
Canadian suppliers; | ||
(2) consult with interested stakeholders, including | ||
the committee, the legislature, health insurance plans, employers, | ||
pharmacies, health care providers and consumers; | ||
(3) develop a registration process for health | ||
insurance plans, pharmacies and prescription drug administering | ||
health care providers who choose to participate in the program; | ||
(4) make a list of imported eligible prescription | ||
drugs and their prices and make that list available to all | ||
participating entities and the general public; | ||
(5) create an outreach and marketing plan to generate | ||
program awareness; | ||
(6) create and staff a helpline to answer questions | ||
and address the needs of consumers, employers, health insurance | ||
plans, pharmacies, health care providers and other affected | ||
sectors; | ||
(7) require annual specific audits of the program; and | ||
(8) carry out other duties in accordance with the | ||
Wholesale Prescription Drug Importation Act that the commission | ||
determines to be necessary for successful implementation of the | ||
program. | ||
Sec. 66.007. ANNUAL REPORTING. (a) Annually, after | ||
implementation, the commission shall report to the governor and the | ||
legislature regarding the operation of the program during the | ||
previous year, including: | ||
(1) which eligible prescription drugs and Canadian | ||
suppliers are included in the program; | ||
(2) the number of participating pharmacies, health | ||
care providers and health insurance plans; | ||
(3) the number of prescriptions dispensed through the | ||
program; | ||
(4) the estimated savings to consumers, health plans, | ||
employers and the state during the previous year and to date; | ||
(5) information regarding implementation of the audit | ||
plan and the correction plans for audit findings; and | ||
(6) any other information requested by the governor or | ||
the legislature or state health authority deems relevant. | ||
Sec. 66.008. COUNTRIES OTHER THAN CANADA ALLOWED BY FEDERAL | ||
LAW. (a) The provisions of the Wholesale Prescription Drug | ||
Importation Act may be extended to any other country allowed by | ||
federal law to import prescription drugs into the United States, at | ||
the discretion of the commission. | ||
SECTION 3. As soon as practicable after the effective date | ||
of this Act, the executive commissioner of the Health and Human | ||
Services Commission and any other state agency designated by the | ||
executive commissioner shall adopt rules necessary to implement | ||
Chapter 66, Health and Safety Code, as added by this Act. | ||
SECTION 4. This Act takes effect September 1, 2023. |