Update as of August 21, 2025
We have received several questions related to the process for supplementing Phase I applications. Recognizing that there is concern over applicants from 2023 attempting to take the opportunity to essentially submit a new application, we nevertheless believe targeted supplementation is warranted.
HB46 emphasizes three specific points:
- A refinement of the foundational directive for DPS; from issuing licenses only as necessary to ensure statewide access to issuing licenses in a manner that ensures patient access in each health region;
- Creation of the satellite location for storage and dispensing to patients at a local level;
- Specific admonishment for licensees to stand up operations within 24 months and continue engaged operation within the program.
The language that emphasizes these points are all new additions to Health and Safety Code Chapter 487, through the amendments in HB46; the language in these provisions were not in existence in 2023 when the application window was open. It is for this reason that the Department is allowing a supplement to – not a rewrite or a replacement of – the information provided in 2023.
If RSD staff determines that the supplemental information provided is responsive to one of these new additions under HB46, the information will be allowed and given appropriate weight by the selection committee. If the information is determined to be responsive only to information requested during the 2023 application window, the information will be discarded and only the information provided during the original application window will be considered.
The Texas Department of Public Safety (DPS), Regulatory Services Division (RSD) is now accepting supplemental applications for the Texas Compassionate Use Program (TCUP). Requested supplemental documents for the dispensing organization license must be submitted through the RSD SFTP portal.
The submission window to supplement will be open from August 15, 2025, through September 15, 2025.
Applicants who have previously applied for a TCUP dispensing organization license should not resubmit a CUP-101 form.
Applicants must submit, as part of their supplemental application, an updated acknowledgments form and a statement of priority for the public health regions. Additionally, the supplemental application must include the following:
- A plan detailing how the applicant would begin operations if licensed including timelines, deliverables, milestones, and projected date for filling prescriptions.
- The plan must also identify how the applicant would provide statewide coverage for patients.
- Current financial portfolio.
- Current Dun & Bradstreet report. (If the applicant does not have a Dun & Bradstreet report, include a statement explaining why.)
- Current balance sheet.
The supplemental window will close at 5:00 p.m. CT on September 15, 2025. Failure to provide the requested supplemental application information will result in termination of the application as incomplete and will not be considered.
Phase 1 Supplemental applicants should have received an email with login information for the portal. If Phase I Supplemental applicants have not received an email with the login information, please contact rsd.cup@dps.texas.gov for assistance.