Bill Text: TX HB25 | 2023-2024 | 88th Legislature | Enrolled
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-Enrolled.html
| H.B. No. 25 | ||
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| 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 | ||
