89R26091 RDR-F     By: King, et al. H.B. No. 46     Substitute the following for H.B. No. 46:     By:  VanDeaver C.S.H.B. No. 46       A BILL TO BE ENTITLED   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.          SECTION 7.  Section 487.104, Health and Safety Code, is   amended by amending Subsection (b) and adding Subsections (b-1),   (d), (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 11 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.          (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.  Sections 487.105(a) and (b), Health and Safety   Code, are amended 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.          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 package or container that contains more than a   total of 1.2 grams 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.          (c)  A dispensing organization may not include in a product   any naturally occurring chemical substance from the cannabis plant   that is not a phytocannabinoid, unless the dispensing organization   obtains approval from the department.          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   by adding Subdivisions (2) and (6) and amending Subdivisions (3),   (4), and (5) to read as follows:                (2)  "Executive commissioner" means the executive   commissioner of the Health and Human Services Commission.                (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:                      (A)  one percent by weight of   tetrahydrocannabinols in each dosage unit; or                      (B)  for tetrahydrocannabinol administered by   pulmonary inhalation, an amount of tetrahydrocannabinol equivalent   to the amount described by Paragraph (A), as prescribed by rule by   the executive commissioner.                (4)  "Medical use" means the ingestion, absorption,   inhalation, 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.                (6)  "Veteran" means a person who has served in:                      (A)  the army, navy, air force, coast guard, or   marine corps of the United States;                      (B)  the state military forces as defined by   Section 431.001, Government Code; or                      (C)  an auxiliary service of one of those branches   of the armed forces.          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:                            (i)  is diagnosed with:                                  (a) [(i)]  epilepsy;                                  (b) [(ii)]  a seizure disorder;                                  (c) [(iii)]  multiple sclerosis;                                  (d) [(iv)]  spasticity;                                  (e) [(v)]  amyotrophic lateral   sclerosis;                                  (f) [(vi)]  autism;                                  (g) [(vii)]  cancer;                                  (h) [(viii)]  an incurable   neurodegenerative disease;                                  (i) [(ix)]  post-traumatic stress   disorder; [or]                                  (j)  a condition that causes chronic   pain, for which a physician would otherwise prescribe an opioid;                                  (k)  glaucoma;                                  (l)  traumatic brain injury;                                  (m)  spinal neuropathy;                                  (n)  Crohn's disease or other   inflammatory bowel disease;                                  (o)  degenerative disc disease;                                  (p)  a terminal illness or a condition   for which a patient is receiving hospice or palliative care;                                  (q) [(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; or                                  (r)  a medical condition designated by   the Department of State Health Services under Subsection (c); or                            (ii)  is an honorably discharged veteran who   would benefit from medical use to address a medical condition; 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)  The Department of State Health Services may designate   medical conditions for which a physician may prescribe low-THC   cannabis under this section.  The executive commissioner shall   adopt rules for the approval of medical conditions under this   section.          (d)  If a patient is diagnosed with a medical condition not   listed in Subsection (a)(3)(A)(i), a physician may submit to the   Department of State Health Services a request for the department to   designate the condition as a medical condition for which a   physician may prescribe low-THC cannabis under this section. 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 executive commissioner shall adopt rules:                (1)  related to medical devices for pulmonary   inhalation of low-THC cannabis; and                (2)  establishing an amount of tetrahydrocannabinols   when administered by pulmonary inhalation that is medically   equivalent to other means of administering low-THC cannabis.          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 169.003, Occupations Code, as amended by this Act, and   Section 169.006, Occupations Code, as added by this Act.          SECTION 18.  This Act takes effect September 1, 2025.