TITLE 25. HEALTH SERVICES
PART 1. DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 1. MISCELLANEOUS PROVISIONS
SUBCHAPTER
D.
The executive commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), adopts an amendment to §1.61, concerning Medical Conditions for which a Physician May Prescribe Low-THC Cannabis; and new §1.63, concerning Pulmonary Inhalation Devices for Low-THC Cannabis.
Section 1.61 is adopted without changes to the proposed text as published in the September 5, 2025, issue of the Texas Register (50 TexReg 5868). This rule will not be republished.
Section 1.63 is adopted with changes to the proposed text as published in the September 5, 2025, issue of the Texas Register (50 TexReg 5868). This rule will be republished.
BACKGROUND AND JUSTIFICATION
The amendment and new section are necessary to comply with House Bill (HB) 46, by King et al, 89th Legislature, Regular Session, 2025, which amended Texas Occupations Code §169.003 to allow DSHS to receive physician requests to add medical conditions to the list of qualifying conditions for which physicians may prescribe low-THC cannabis under the Texas Compassionate Use Program at the Texas Department of Public Safety. HB 46 also amended Texas Occupations Code Chapter 169 to add §169.006 to allow physicians to prescribe pulmonary inhalation as the means of administration of low-THC cannabis and establish a timeline for reviewing and approving pulmonary inhalation devices.
COMMENTS
The 31-day comment period ended October 6, 2025.
During this period, DSHS received comments regarding the proposed rules from 13 stakeholders. DSHS received comments from East Texas Medicinal Meds; Goodblend; Marijuana Policy Project; PAXX; Texas Cannabis Clinic; Texas Cannabis Policy Center; Texas Original Compassionate Cultivation; The Center TX; Thrive Medical Cannabis; and five stakeholders not representing an organization. A summary of comments relating to the rules and DSHS' responses follows.
Comment: A commenter suggested deleting the requirement of DSHS providing forms requesting the addition of non-neurodegenerative diseases to the list of medical conditions to the Department of Public Safety (DPS) who will then submit requests to the legislature for consideration. The commenter suggests that DSHS in §1.61(c)(1) has the authority to add non-neurodegenerative diseases to the list without legislative approval.
Response: DSHS disagrees and declines to revise the rule in response to this comment. HB 46 requires any requests for non-neurodegenerative diseases added to the list must be approved by the legislature.
Comment: Several commenters suggested that §1.63(c) be revised so that qualifying physicians under Texas Occupations Code Chapter 169 may not be required to prescribe a pulmonary inhalation device for low-THC cannabis to a patient.
Response: DSHS partially agrees with this suggestion and added language that a qualified physician may, but is not required to, prescribe pulmonary inhalation as the means of administration for low-THC cannabis. The rule does not require physicians to prescribe a pulmonary inhalation device, and language was added to §1.63(c) to make this clear.
Comment: Several commenters suggested that §1.63(d) be revised so that dispensing organizations may submit a form to DSHS to request the addition of a pulmonary inhalation device to the list from which a physician may choose when prescribing and removing this responsibility from physicians.
Response: DSHS agrees with this suggestion and rule language in §1.63(d) has been modified to allow qualifying dispensing organizations to submit a form to DSHS requesting the addition of a pulmonary inhalation device.
Comment: A commenter suggested §1.63 be revised so that licensed dispensing organizations may provide an equivalent substitute for a physician prescribed pulmonary inhalation device.
Response: DSHS disagrees and declines to include this language. Instead, §1.63(d) has been modified to allow qualifying dispensing organizations to submit a form to DSHS to request approval of a pulmonary inhalation device that may be dispensed to a patient for the pulmonary inhalation of low-THC cannabis.
Comment: A commenter suggested that §1.63(d) be revised so pulmonary inhalation device manufacturers may submit a form to DSHS to request the addition of a pulmonary inhalation device to the list from which a physician may choose when prescribing and removing this responsibility from physicians.
Response: DSHS disagrees with this request and declines to edit this section. DSHS has modified rule language in §1.63(d) allowing licensed dispensing organizations to submit a form to DSHS requesting the addition of a pulmonary inhalation device.
Comment: Several commenters suggested that §1.63 be revised so that DSHS establishes pulmonary inhalation device safety standards.
Response: DSHS partially agrees. DSHS currently does not have the authority to set pulmonary inhalation device safety standards, but rule language has been added to new §1.63(f) requiring that a request for review of a pulmonary inhalation device must include an attestation from the requester that the proposed pulmonary inhalation device is safe and effective for the pulmonary inhalation of low-THC cannabis. Patients should follow the pulmonary inhalation device manufacturer safety guidelines.
Comment: Several commenters suggested that §1.63(f) be revised so that DSHS must review pulmonary inhalation devices within a shorter time frame than the proposed six months with stakeholders to determine potential changes to this section.
Response: DSHS agrees and has revised rule language in proposed §1.63(f), renumbered for adoption to §1.63(g), so that DSHS must review pulmonary inhalation devices within four months with stakeholders to determine potential changes to this section.
Comment: Several commenters suggested that §1.63 be revised to include cannabis flower as a way of prescription for low-THC cannabis.
Response: DSHS declines to revise the rule to include cannabis flower as a prescription option for low-THC cannabis. This request is out of scope of statutory changes based on HB 46.
DSHS made non substantive changes to the definition of pulmonary inhalation devices in §1.63(a) to clarify that the pulmonary inhalation device will be dispensed to patients.
STATUTORY AUTHORITY
The amendment and new section are adopted under Texas Government Code §524.0151, which provides that the executive commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services system, and Texas Health and Safety Code §1001.075, which authorizes the executive commissioner of HHSC to adopt rules and policies for the operation and provision of health and human services by DSHS and for the administration of Texas Health and Safety Code Chapter 1001 and Texas Occupations Code Chapter 169.
§1.63.
(a) A pulmonary inhalation device is a device designed, marketed, and dispensed to allow a patient to inhale an aerosolized or vaporized substance.
(b) A pulmonary inhalation device must not burn or ignite a substance for the purpose of inhaling smoke.
(c) A qualifying physician under Texas Occupations Code Chapter 169 may, but is not required to, prescribe pulmonary inhalation as the means of administration for low-THC cannabis to a patient who is qualified to receive a low-THC cannabis prescription.
(d) A licensed dispensing organization, as defined in Texas Health and Safety Code Chapter 487, may submit a form to DSHS to request approval of a pulmonary inhalation device that may be dispensed to a patient for the pulmonary inhalation of low-THC cannabis.
(e) A request under subsection (d) of this section must be submitted using the form, Request to Add Medical Conditions for Which a Physician May Prescribe Low-THC Cannabis or Add Pulmonary Inhalation Devices for Low-THC Cannabis, located on the DSHS website.
(f) A request under subsection (d) of this section must include an attestation from the requester that the proposed pulmonary inhalation device is safe and effective for the pulmonary inhalation of low-THC cannabis.
(g) The Texas Department of State Health Services must review pulmonary inhalation devices every four months with stakeholders to determine potential changes to this section.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on November 10, 2025.
TRD-202504111
Cynthia Hernandez
General Counsel
Department of State Health Services
Effective date: November 30, 2025
Proposal publication date: September 5, 2025
For further information, please call: (512) 776-3554