H.B. No. 46
 
 
 
 
AN ACT
  relating to the medical use of low-THC cannabis under and the
  administration of the Texas Compassionate-Use Program; requiring
  registration.
         BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
         SECTION 1.  Section 487.053(a), Health and Safety Code, is
  amended to read as follows:
         (a)  The department shall:
               (1)  issue or renew a license to operate as a dispensing
  organization to each applicant who satisfies the requirements
  established under this chapter; and
               (2)  register directors, owners, managers, members,
  and employees of each dispensing organization.
         SECTION 2.  Section 487.054, Health and Safety Code, is
  amended by adding Subsections (c) and (d) to read as follows:
         (c)  Information within the registry regarding patient
  identification, including the fact that a person is listed as a
  patient in the registry, is confidential and may only be accessed by
  the department, registered physicians, and dispensing
  organizations for the purposes of this chapter.  Confidential
  information under this subsection may not be disclosed except as
  authorized under this chapter and is not subject to disclosure
  under Chapter 552, Government Code.
         (d)  Notwithstanding Subsection (c), on request by a
  patient, the department may release patient information contained
  in the registry to the patient or a person designated by the
  patient.
         SECTION 3.  Section 487.101, Health and Safety Code, is
  amended to read as follows:
         Sec. 487.101.  LICENSE REQUIRED.  (a) A license issued by the
  department under this chapter is required to operate a dispensing
  organization.
         (b)  A dispensing organization licensed under this chapter
  is not required to apply for an additional license for the use of a
  satellite location for secure storage of low-THC cannabis if:
               (1)  the address of the satellite location was included
  in the application; or
               (2)  the dispensing organization obtains approval from
  the department under Section 487.1035.
         SECTION 4.  Section 487.102, Health and Safety Code, is
  amended to read as follows:
         Sec. 487.102.  ELIGIBILITY FOR LICENSE.  An applicant for a
  license to operate as a dispensing organization is eligible for the
  license if:
               (1)  as determined by the department, the applicant
  possesses:
                     (A)  the technical and technological ability to
  cultivate and produce low-THC cannabis;
                     (B)  the ability to secure:
                           (i)  the resources and personnel necessary
  to operate as a dispensing organization; and
                           (ii)  premises reasonably located to allow
  patients listed on the compassionate-use registry access to the
  organization through existing infrastructure;
                     (C)  the ability to maintain accountability for
  the raw materials, the finished product, and any by-products used
  or produced in the cultivation or production of low-THC cannabis to
  prevent unlawful access to or unlawful diversion or possession of
  those materials, products, or by-products; and
                     (D)  the financial ability to maintain operations
  for not less than two years from the date of application;
               (2)  each director, owner, manager, member, or employee
  of the applicant is registered under Subchapter D; and
               (3)  the applicant satisfies any additional criteria
  determined by the director to be necessary to safely implement this
  chapter.
         SECTION 5.  Section 487.103(b), Health and Safety Code, is
  amended to read as follows:
         (b)  The application must include:
               (1)  the name and address of the applicant;
               (2)[,] the name and address of each of the applicant's
  directors, owners, managers, members, and employees;
               (3)  the address of any satellite location that will be
  used by the applicant for secure storage of low-THC cannabis under
  Section 487.1035;[,] and
               (4)  any other information considered necessary by the
  department to determine the applicant's eligibility for the
  license.
         SECTION 6.  Subchapter C, Chapter 487, Health and Safety
  Code, is amended by adding Section 487.1035 to read as follows:
         Sec. 487.1035.  SATELLITE LOCATIONS. (a) A dispensing
  organization licensed under this chapter may operate one or more
  satellite locations in addition to the organization's primary
  location to securely store low-THC cannabis for distribution.
         (b)  A satellite location must be approved by the department
  before a dispensing organization may operate the location. A
  dispensing organization may apply for approval in the form and
  manner prescribed by the department.
         (c)  The department must act on an application submitted
  under Subsection (b) not later than the 180th day after the date the
  application is submitted to the department.
         (d)  The director shall adopt rules regarding the design and
  security requirements for satellite locations.
         (e)  A dispensing organization may not operate more than one
  satellite location in a public health region designated under
  Section 121.007 until the dispensing organization operates one
  satellite location in each public health region.
         (f)  A location previously approved by the department as a
  patient pickup location before September 1, 2025, is considered to
  be approved as a satellite location under Subsection (b) for
  purposes of this section and is permitted to:
               (1)  operate as a patient pickup location; and
               (2)  securely store low-THC cannabis for distribution.
         SECTION 7.  Section 487.104, Health and Safety Code, is
  amended by amending Subsection (b) and adding Subsections (b-1),
  (d), (d-1), (e), and (f) to read as follows:
         (b)  Except as provided by Subsection (b-1), if [If] the
  department denies the issuance or renewal of a license under
  Subsection (a), the applicant is entitled to a hearing. Chapter
  2001, Government Code, applies to a proceeding under this section.
         (b-1)  If the department denies the issuance of a license
  under this section to an applicant that has never held a license
  under this section, the applicant is not entitled to a hearing.
         (d)  The department shall issue 15 licenses under this
  section to dispensing organizations in this state provided that the
  department receives applications from a sufficient number of
  applicants meeting the requirements for eligibility under this
  subchapter.
         (d-1)  The department shall issue initial licenses to
  dispensing organizations under this section based on a competitive
  evaluation of applicant qualifications relative to other
  applicants.
         (e)  The department shall issue and renew licenses under this
  section in a manner that ensures adequate access to low-THC
  cannabis for patients registered in the compassionate-use registry
  in each public health region designated under Section 121.007.
         (f)  The director shall adopt rules to establish a timeline
  for reviewing and taking action on an application submitted under
  this section.
         SECTION 8.  Subchapter C, Chapter 487, Health and Safety
  Code, is amended by adding Section 487.1045 to read as follows:
         Sec. 487.1045.  REQUIREMENT OF LICENSE HOLDER TO BEGIN AND
  MAINTAIN OPERATIONS. (a) An applicant issued a license to operate a
  dispensing organization must begin dispensing low-THC cannabis not
  later than 24 months after the date the license is issued and
  continue dispensing low-THC cannabis during the term of a license
  issued under this subchapter.
         (b)  The director shall adopt rules to:
               (1)  monitor whether a dispensing organization is using
  a license issued under this subchapter to dispense low-THC
  cannabis; and
               (2)  revoke the license of a dispensing organization
  that does not dispense low-THC cannabis within the time required by
  this section or that discontinues dispensing low-THC cannabis
  during the term of a license.
         SECTION 9.  Section 487.105, Health and Safety Code, is
  amended by amending Subsections (a) and (b) and adding Subsection
  (c-1) to read as follows:
         (a)  An applicant for the issuance or renewal of a license to
  operate as a dispensing organization shall provide the department
  with the applicant's name and the name of each of the applicant's
  directors, owners, managers, members, and employees.
         (b)  Before a dispensing organization licensee hires a
  manager or employee for the organization, the licensee must provide
  the department with the name of the prospective manager or
  employee. The licensee may not transfer the license to another
  person before that prospective applicant and the applicant's
  directors, owners, managers, members, and employees pass a criminal
  history background check and are registered as required by
  Subchapter D.
         (c-1)  This section does not apply to a director, owner,
  manager, member, or employee who does not exercise direct control
  over the daily operations of the dispensing organization.
         SECTION 10.  Section 487.107, Health and Safety Code, is
  amended by adding Subsection (c) to read as follows:
         (c)  A dispensing organization may not dispense to a person
  low-THC cannabis in a:
               (1)  package or container that contains more than a
  total of one gram of tetrahydrocannabinols; or
               (2)  medical device for pulmonary inhalation that
  contains more than one gram of tetrahydrocannabinols.
         SECTION 11.  Subchapter C, Chapter 487, Health and Safety
  Code, is amended by adding Section 487.1071 to read as follows:
         Sec. 487.1071.  CANNABINOIDS ELIGIBLE FOR DISPENSING. (a)
  In this section, "phytocannabinoid" means a chemical substance:
               (1)  created naturally by a plant of the species
  Cannabis sativa L. that is separated from the plant by a mechanical
  or chemical extraction process;
               (2)  created naturally by a plant of the species
  Cannabis sativa L. that binds to or interacts with the cannabinoid
  receptors of the endocannabinoid system; or
               (3)  produced by decarboxylation from a naturally
  occurring cannabinoid acid without the use of a chemical catalyst.
         (b)  A dispensing organization may not dispense a low-THC
  cannabis product that contains a cannabinoid that is not a
  phytocannabinoid.
         SECTION 12.  Section 487.151(a), Health and Safety Code, is
  amended to read as follows:
         (a)  An individual who is a director, owner, manager, member,
  or employee of a dispensing organization must apply for and obtain a
  registration under this section.
         SECTION 13.  Section 487.201, Health and Safety Code, is
  amended to read as follows:
         Sec. 487.201.  COUNTIES AND MUNICIPALITIES MAY NOT PROHIBIT
  LOW-THC CANNABIS. A municipality, county, or other political
  subdivision may not enact, adopt, or enforce a rule, ordinance,
  order, resolution, or other regulation that prohibits the
  cultivation, production, storage, dispensing, or possession of
  low-THC cannabis, as authorized by this chapter.
         SECTION 14.  Section 169.001, Occupations Code, is amended
  to read as follows:
         Sec. 169.001.  DEFINITIONS.  In this chapter:
               (1)  "Chronic pain" means pain that is not relieved
  with acute, post-surgical, post-procedure, or persistent
  non-chronic pain treatment and is associated with a chronic
  pathological process that causes continuous or intermittent severe
  pain for more than 90 days and for which tetrahydrocannabinol is a
  viable method of treatment.
               (1-a)  "Department" means the Department of Public
  Safety.
               (1-b)  "Executive commissioner" means the executive
  commissioner of the Health and Human Services Commission.
               (2) [(1-a)]  "Incurable neurodegenerative disease"
  means a disease designated as an incurable neurodegenerative
  disease by rule of the executive commissioner [of the Health and
  Human Services Commission], adopted in consultation with the
  National Institutes of Health.
               (3)  "Low-THC cannabis" means the plant Cannabis sativa
  L., and any part of that plant or any compound, manufacture, salt,
  derivative, mixture, preparation, resin, or oil of that plant that
  contains not more than 10 milligrams [one percent by weight] of
  tetrahydrocannabinols in each dosage unit.
               (4)  "Medical use" means the ingestion, absorption, or
  insertion by a means of administration other than by smoking of a
  prescribed amount of low-THC cannabis by a person for whom low-THC
  cannabis is prescribed under this chapter.
               (5)  "Smoking" means burning or igniting a substance
  and inhaling the smoke.  The term does not include inhaling a
  medication or other substance that is otherwise aerosolized or
  vaporized for administration by pulmonary inhalation.
         SECTION 15.  Section 169.003, Occupations Code, is amended
  to read as follows:
         Sec. 169.003.  PRESCRIPTION OF LOW-THC CANNABIS.  (a)  A
  physician described by Section 169.002 may prescribe low-THC
  cannabis to a patient if:
               (1)  the patient is a permanent resident of the state;
               (2)  the physician complies with the registration
  requirements of Section 169.004; and
               (3)  the physician certifies to the department that:
                     (A)  the patient is diagnosed with:
                           (i)  epilepsy;
                           (ii)  a seizure disorder;
                           (iii)  multiple sclerosis;
                           (iv)  spasticity;
                           (v)  amyotrophic lateral sclerosis;
                           (vi)  autism;
                           (vii)  cancer;
                           (viii)  an incurable neurodegenerative
  disease;
                           (ix)  post-traumatic stress disorder;
                           (x)  a condition that causes chronic pain;
                           (xi)  traumatic brain injury;
                           (xii)  Crohn's disease or other inflammatory
  bowel disease;
                           (xiii)  a terminal illness or a condition
  for which a patient is receiving hospice or palliative care; or
                           (xiv) [(x)]  a medical condition that is
  approved for a research program under Subchapter F, Chapter 487,
  Health and Safety Code, and for which the patient is receiving
  treatment under that program; and
                     (B)  the physician determines the risk of the
  medical use of low-THC cannabis by the patient is reasonable in
  light of the potential benefit for the patient.
         (b)  Each prescription issued by a physician to a patient for
  low-THC cannabis:
               (1)  may only provide for a 90-day supply of low-THC
  cannabis based on the dosage prescribed to the patient; and
               (2)  may provide up to four refills of a 90-day supply
  of low-THC cannabis.
         (c)  A physician may prescribe more than one package in a
  90-day period.
         (d)  A physician may submit to the Department of State Health
  Services a request that the department report to the legislature
  that low-THC cannabis may be beneficial to treat a specific medical
  condition not listed in Subsection (a)(3)(A).  The request must be
  accompanied by medical evidence such as peer-reviewed published
  research demonstrating that low-THC cannabis may be beneficial to
  treat that medical condition.  The executive commissioner by rule
  shall prescribe the manner in which a physician may submit a request
  under this subsection.
         SECTION 16.  Chapter 169, Occupations Code, is amended by
  adding Section 169.006 to read as follows:
         Sec. 169.006.  ADMINISTRATION OF LOW-THC CANNABIS BY
  PULMONARY INHALATION.  (a) A physician may prescribe pulmonary
  inhalation of an aerosol or vapor as a means of administration of
  low-THC cannabis if the physician determines that based on the
  patient's condition there is a medical necessity for that means of
  administration.
         (b)  The prescription under Subsection (a) must specify the
  amount of tetrahydrocannabinols in each dosage unit to be
  administered by pulmonary inhalation that is medically necessary
  based on the patient's condition.
         (c)  The executive commissioner shall adopt rules:
               (1)  related to medical devices for pulmonary
  inhalation of low-THC cannabis; and
               (2)  establishing a reasonable timeline for reviewing
  and granting approval for medical devices for pulmonary inhalation.
         SECTION 17.  Not later than October 1, 2025:
               (1)  the director of the Department of Public Safety
  shall adopt the rules necessary to implement the changes in law made
  by this Act to Chapter 487, Health and Safety Code; and
               (2)  the executive commissioner of the Health and Human
  Services Commission shall adopt the rules necessary to implement
  Section 169.006, Occupations Code, as added by this Act.
         SECTION 18.  Provided that applicants for a license to
  operate as a dispensing organization have met the requirements for
  approval provided by Subchapter C, Chapter 487, Health and Safety
  Code, as amended by this Act, the Department of Public Safety shall:
               (1)  not later than December 1, 2025, license at least
  nine new dispensing organizations from applications submitted
  before July 1, 2025; and
               (2)  not later than April 1, 2026, in addition to any
  licenses issued by the Department of Public Safety under
  Subdivision (1) of this section, license at least three new
  dispensing organizations from applications submitted at any time.
         SECTION 19.  This Act takes effect September 1, 2025.
 
 
  ______________________________ ______________________________
     President of the Senate Speaker of the House     
 
 
         I certify that H.B. No. 46 was passed by the House on May 13,
  2025, by the following vote:  Yeas 122, Nays 21, 2 present, not
  voting; that the House refused to concur in Senate amendments to
  H.B. No. 46 on May 30, 2025, and requested the appointment of a
  conference committee to consider the differences between the two
  houses; that the House adopted the conference committee report on
  H.B. No. 46 on June 1, 2025, by the following vote:  Yeas 138, Nays
  1, 2 present, not voting; that the House adopted S.C.R. No. 56
  authorizing certain corrections in H.B. No. 46 on June 1, 2025, by
  the following vote: Yeas 137, Nays 0, 1 present, not voting; and
  that the House adopted H.C.R. No. 171 authorizing certain
  corrections in H.B. No. 46 on June 2, 2025, by the following vote:
  Yeas 138, Nays 0, 1 present, not voting.
 
  ______________________________
  Chief Clerk of the House   
 
         I certify that H.B. No. 46 was passed by the Senate, with
  amendments, on May 27, 2025, by the following vote:  Yeas 31, Nays
  0; at the request of the House, the Senate appointed a conference
  committee to consider the differences between the two houses; that
  the Senate adopted the conference committee report on H.B. No. 46 on
  June 1, 2025, by the following vote:  Yeas 31, Nays 0; that the
  Senate adopted S.C.R. No. 56 authorizing certain corrections in
  H.B. No. 46 on June 1, 2025, by the following vote: Yeas 31, Nays 0;
  and that the Senate adopted H.C.R. No. 171 authorizing certain
  corrections in H.B. No. 46 on June 2, 2025, by the following vote:
  Yeas 31, Nays 0.
 
  ______________________________
  Secretary of the Senate   
  APPROVED: __________________
                  Date       
   
           __________________
                Governor