DPS sets competitive, two‑phase process to expand compassionate‑use program under House Bill 46

The Texas Department of Public Safety on Aug. 7 announced a two‑phase competitive process to expand the Texas Compassionate Use Program to 15 licensees, saying state law (House Bill 46) requires the agency to add 12 new licensees and to ensure geographic coverage across HHSC health regions.

Chief Wayne Miller, who leads the department’s Regulatory Services Division, outlined a plan that prioritizes 139 applicants who filed during the 2023 application window: the first nine of the 12 new licenses must be selected from that group. DPS will open a dual application window beginning Aug. 8 that runs through 5 p.m. Sept. 15 for (1) supplemental submissions from the phase‑1 applicants and (2) new phase‑2 applications from other prospective licensees.

Miller said the phase‑1 supplemental window is not intended as a complete rewrite of prior applications but to capture updated financial documentation and a small set of new declarations the legislature now requires. He described two such declarations: one barring a physician who can prescribe under the program from retaining ownership in a licensee, and a “no double‑dipping” declaration preventing the same ownership interests from appearing in multiple applications. Miller said applicants who withdraw by Aug. 15 will receive an application‑fee refund; otherwise the fee becomes nonrefundable.

The DPS plan reflects the statutory timetable Miller summarized: the agency aims to announce conditional approvals for the first nine licensees by Dec. 1, 2025, and to name the final three by April 1, 2026. Licensees granted conditional approval will have 24 months to stand up seed‑to‑sale operations; DPS said it will also maintain a small eligibility list of backup applicants in case conditional licensees fail to become operational.

The selection will be made by a nine‑member internal scoring committee using a published scoring sheet. Miller said the scoring categories include: infrastructure and security plans; internal accountability measures to prevent diversion; financial stability and liquidity; and testing/manufacturing and laboratory technology. He said the DPS score sheet and supporting instructions would be published on the department website when the application window opens.

Miller described how the statute requires assignment of licensees to Texas Health and Human Services health regions to improve patient access. A licensee assigned to a health region may either place its cultivation/manufacturing center in that region or open a satellite dispensing location there. DPS said satellite locations are limited to storage and dispensing (no cultivation or manufacture) and that a licensee may not open additional satellite locations within a health region until it has at least one satellite operational in every health region assigned to it under the statute.

The chief asked applicants to avoid last‑minute submissions and warned DPS staff will reject submissions that attempt to substitute a materially different ownership structure into an old application; material changes should be submitted as new phase‑2 applications. "The legislature has now said this program is to have 15 licensees," Miller said in closing, and DPS described the implementation plan as its method for meeting that statutory requirement while preserving a competitive, transparent process.

Ending: The commission voted to approve the DPS implementation plan for expanding the Compassionate Use Program consistent with House Bill 46. DPS said more application guidance, the score sheet, and submission instructions would be posted on its website and provided directly to the phase‑1 applicants.