Title HS, Health and Safety Code

Sec. 489.151. ACTION AGAINST PHYSICIAN'S LICENSE PROHIBITED. Notwithstanding any other law, the Texas Medical Board may not revoke, fail to renew, suspend, or take any action against a physician's license under Subchapter B, Chapter 164, Occupations Code, based solely on the phys…

Sec. 490.001. DEFINITIONS. In this chapter: (1) "Commissioner" means the commissioner of state health services. (2) "Executive commissioner" means the executive commissioner of the Health and Human Services Commission. (3) "Investigational drug, biological product, or device" mea…

Sec. 490.002. DESIGNATION OF SEVERE CHRONIC DISEASES. The commissioner shall designate the medical conditions considered to be severe chronic diseases under this chapter. Added by Acts 2023, 88th Leg., R.S., Ch. 1082 (S.B. 773), Sec. 2, eff. June 18, 2023.

Sec. 490.003. RULES. The executive commissioner shall adopt rules necessary to administer this chapter. Added by Acts 2023, 88th Leg., R.S., Ch. 1082 (S.B. 773), Sec. 2, eff. June 18, 2023. SUBCHAPTER B. ACCESS TO INVESTIGATIONAL DRUGS, BIOLOGICAL PRODUCTS, AND DEVICES FOR PATIEN…

Sec. 490.051. PATIENT ELIGIBILITY. A patient is eligible to access and use an investigational drug, biological product, or device under this chapter if: (1) the patient has a severe chronic disease the commissioner designates under Section 490.002 that the patient's treating phys…

Sec. 490.052. INFORMED CONSENT. (a) Before receiving an investigational drug, biological product, or device, an eligible patient must sign a written informed consent. If the patient is a minor or lacks the mental capacity to provide informed consent, a parent, guardian, or conser…

Sec. 490.053. PROVISION OF INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT, OR DEVICE BY MANUFACTURER. (a) A manufacturer of an investigational drug, biological product, or device may make available the manufacturer's investigational drug, biological product, or device to eligible patie…

Sec. 490.054. CAUSE OF ACTION NOT CREATED. This chapter does not create a private or state cause of action against a manufacturer of an investigational drug, biological product, or device or against any other person or entity involved in the care of an eligible patient using the …

Sec. 490.055. STATE MAY NOT INTERFERE WITH ACCESS TO INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT, OR DEVICE. An official, employee, or agent of this state may not block or attempt to block an eligible patient's access to an investigational drug, biological product, or device under t…

Sec. 490.101. EFFECT ON HEALTH CARE COVERAGE FOR CLINICAL TRIAL ENROLLEES. This chapter does not affect the coverage of enrollees in clinical trials under Chapter 1379, Insurance Code. Added by Acts 2023, 88th Leg., R.S., Ch. 1082 (S.B. 773), Sec. 2, eff. June 18, 2023. SUBCHAPTE…

Sec. 490.151. ACTION AGAINST PHYSICIAN'S LICENSE PROHIBITED. Notwithstanding any other law, the Texas Medical Board may not revoke, fail to renew, suspend, or take any action against a physician's license under Subchapter B, Chapter 164, Occupations Code, based solely on the phys…

Sec. 491.001. DEFINITIONS. In this chapter: (1) "Individualized investigational treatment" means a drug, biological product, or device unique to and produced exclusively for use by a patient, based on the patient's genetic profile. The term includes individualized gene therapy an…

Sec. 491.051. HEALTH CARE FACILITY ELIGIBILITY. A health care facility is eligible to provide an individualized investigational treatment under this chapter if the facility is operating under a federal assurance for the protection of human subjects under 42 U.S.C. Section 289(a) …

Sec. 491.052. PATIENT ELIGIBILITY. A patient is eligible to access an individualized investigational treatment under this chapter if: (1) the patient: (A) has a life-threatening illness or severely debilitating illness; (B) has considered all other treatment options currently app…

Sec. 491.053. INFORMED CONSENT. (a) An eligible patient may not access an individualized investigational treatment unless the patient provides written informed consent. If the patient is a minor or lacks the mental capacity to provide informed consent, a parent, legal guardian, m…

Sec. 491.054. ACCESS TO TREATMENT; COSTS. (a) A manufacturer operating within an eligible health care facility and in compliance with all applicable federal assurance laws and regulations may make available an individualized investigational treatment, and an eligible patient may …

Sec. 491.055. DEBT LIABILITY ON DEATH OF PATIENT. If a patient dies while receiving an individualized investigational treatment, the patient's heirs are not liable for any outstanding debt related to the treatment or lack of health coverage due to the treatment. Added by Acts 202…

Sec. 491.056. NO PRIVATE CAUSE OF ACTION. This chapter does not create a private cause of action against a manufacturer of an individualized investigational treatment or against any other person involved in the care of an eligible patient using the treatment for any harm to the p…

Sec. 491.057. PROHIBITED STATE INTERFERENCE WITH ACCESS TO TREATMENT. (a) An officer, employee, or agent of this state may not block or attempt to block an eligible patient's access to an individualized investigational treatment that complies with this chapter and rules adopted u…

Sec. 491.058. FUNDING; DISBURSEMENT BY COMMISSION. (a) The commission and consortium members may solicit and accept gifts, grants, and donations of any kind received from sources other than the state for purposes of funding drug development clinical trials under this subchapter. …

Sec. 491.059. REPORTING REQUIREMENTS. (a) A consortium selected to conduct ibogaine drug development clinical trials shall quarterly prepare and submit to the commission: (1) a report on the progress of the drug development clinical trials conducted under this subchapter; and (2)…

Sec. 491.060. ALLOCATION OF REVENUE ATTRIBUTABLE TO INTELLECTUAL PROPERTY AND OTHER RIGHTS. (a) The revenue attributable to all intellectual property rights and other commercial rights arising from drug development clinical trials conducted by a consortium under this subchapter d…

Sec. 491.061. USE OF STATE REVENUE. (a) The comptroller shall deposit the revenue received under Section 491.060 to the credit of the general revenue fund. (b) Of the amount deposited under Subsection (a), 25 percent may be appropriated only to programs that assist veterans in th…

Sec. 491.101. HEALTH COVERAGE. This chapter does not affect: (1) the coverage required of an insurer under the Insurance Code; or (2) health care coverage of enrollees in clinical trials under Chapter 1379, Insurance Code. Added by Acts 2025, 89th Leg., R.S., Ch. 285 (S.B. 984), …

Sec. 491.102. COVERAGE OPTIONAL. A health benefit plan issuer, third-party administrator, or governmental agency may, but is not required to, provide coverage for the cost of an individualized investigational treatment or the cost of services related to the use of an individualiz…

Sec. 491.103. HOSPITAL SERVICES. This chapter does not require a hospital or health care facility licensed under Subtitle B, Title 4, to provide new or additional services unless approved by the hospital or facility. Added by Acts 2025, 89th Leg., R.S., Ch. 285 (S.B. 984), Sec. 1…

Sec. 491.104. GOVERNMENTAL AGENCY NOT RESPONSIBLE FOR COSTS. This chapter does not require a governmental agency to pay costs associated with the use, care, or treatment of a patient accessing an individualized investigational treatment. Added by Acts 2025, 89th Leg., R.S., Ch. 2…

Sec. 491.151. PROHIBITED ACTION AGAINST LICENSE HOLDER OR MEDICAID PARTICIPANT. (a) A state licensing board may not revoke, fail to renew, suspend, or take any action against a health care provider's license issued under Title 3, Occupations Code, based solely on the provider's r…

Sec. 501.001. DEFINITIONS. In this chapter: (1) Repealed by Acts 2015, 84th Leg., R.S., Ch. 1, Sec. 3.1639(96), eff. April 2, 2015. (2) "Commerce" includes the operation of a business or service establishment and other commerce in this state that is subject to the jurisdiction of…

Sec. 501.002. HAZARDOUS SUBSTANCE DESCRIBED. (a) A hazardous substance is: (1) a substance or mixture of substances that is toxic, corrosive, extremely flammable, flammable, combustible, an irritant, or a strong sensitizer, or that generates pressure through decomposition, heat, …

Sec. 501.003. DESIGNATION OF RADIOACTIVE SUBSTANCE AS HAZARDOUS. The executive commissioner by rule shall designate a radioactive substance to be a hazardous substance if, with respect to the substance as used in a particular class of article or as packaged, the executive commiss…

Sec. 501.004. DESIGNATION OF STRONG SENSITIZER. Before designating a substance as a strong sensitizer, the department must determine that the substance has a significant potential for causing hypersensitivity considering the frequency of occurrence and the severity of the reactio…

Sec. 501.005. EXCLUSION. This chapter does not apply to the manufacture, distribution, sale, or use of diapers. Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. SUBCHAPTER B. REGULATION OF SUBSTANCES

Sec. 501.021. FLAMMABILITY STANDARDS; DETERMINATION OF FLAMMABILITY. (a) The executive commissioner by rule shall establish the methods for determining the flammability of solids, fabrics, children's clothing, household furnishings, and the contents of self-pressurized containers…

Sec. 501.022. DESIGNATION OF BANNED HAZARDOUS SUBSTANCES. (a) The executive commissioner by rule shall designate as a banned hazardous substance any article, including clothing intended for the use of children, that is not properly packaged or that does not comply with applicable…

Sec. 501.023. GENERAL LABELING AND PACKAGING REQUIREMENTS. (a) The department shall ensure that each hazardous substance is labeled sufficiently to inform its user of the dangers involved in using, storing, or handling the substance, of actions to be taken or avoided, and to give…

Sec. 501.0231. LABELING OF CERTAIN TOYS AND GAMES. (a) Toys or games intended for use by children, including the parts of those toys or games, shall be labeled in the manner required by department rule. The rules adopted under this subsection shall be consistent with federal guid…

Sec. 501.0232. REVIEW AND LABELING OF HAZARDOUS ART MATERIALS. (a) Art materials shall be reviewed by a toxicologist. (b) Art materials shall be labeled in the manner required by department rule. The rules adopted under this subsection shall be consistent with the Federal Hazardo…

Sec. 501.0233. PACKAGING OF HAZARDOUS SUBSTANCES. Hazardous substances shall be packaged in the manner required by special packaging rules adopted by the executive commissioner. The rules adopted under this section shall be consistent with federal special packaging regulations ad…

Sec. 501.024. REGISTRATION. (a) A person who manufactures, imports, or repacks a hazardous substance that is distributed in this state or who distributes a hazardous substance in this state under the person's private brand name shall have on file with the department a registratio…

Sec. 501.0245. NOTICE OF RADIOACTIVE SUBSTANCE RELEASE. (a) In this section, "radioactive substance" has the meaning assigned by Section 401.003. (b) Notwithstanding Subchapter H, Chapter 418, Government Code, or any other law requiring confidentiality, the department or any othe…

Sec. 501.025. RULES. The executive commissioner may adopt reasonable rules necessary for the efficient administration and enforcement of this chapter. The rules must conform with regulations adopted under the Federal Hazardous Substances Act (15 U.S.C. Section 1261 et seq.), as a…

Sec. 501.026. FEES. The executive commissioner by rule shall set reasonable registration fees in an amount as prescribed by Section 12.0111. Added by Acts 2001, 77th Leg., ch. 360, Sec. 9, eff. Sept. 1, 2001. Amended by: Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1269, …

Sec. 501.031. EXAMINATIONS AND INVESTIGATIONS. (a) To enforce this chapter, an officer, employee, or agent of the department, on the presentation of appropriate credentials to the owner, operator, or agent, at reasonable times may enter a factory, warehouse, or establishment in w…

Sec. 501.032. RECORDS OF HAZARDOUS SUBSTANCE IN COMMERCE. (a) For the enforcement of this chapter, a carrier engaged in commerce, a person receiving a hazardous substance in commerce, or a person holding a hazardous substance received in commerce, on request of the department sha…

Sec. 501.033. SEIZURE AND DISPOSITION OF BANNED OR MISBRANDED HAZARDOUS SUBSTANCE. (a) If an authorized agent of the department has good reason to believe that a hazardous substance is a banned or misbranded hazardous substance, the agent shall affix to the article a tag or other…