Title HS, Health and Safety Code

Sec. 491.051. PATIENT ELIGIBILITY. A patient is eligible to access and use an investigational sun protection product if the patient's physician: (1) in consultation with the patient, has considered all other sun protection products currently approved by the United States Food and…

Sec. 491.051. ESTABLISHMENT OF CONSORTIUM. (a) A consortium may be established under this section and apply for commission selection under this subchapter to conduct drug development clinical trials with ibogaine and secure the United States Food and Drug Administration's approva…

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. 491.052. INFORMED CONSENT. (a) Before recommending or prescribing an investigational sun protection product, a physician must require an eligible patient to sign a written informed consent form. (b) If the patient is a minor or lacks the mental capacity to provide informed c…

Sec. 491.052. LEAD INSTITUTION; ADMINISTRATION; PERSONNEL. (a) A consortium established under this subchapter shall select a lead institution of higher education from among the consortium's members to represent the consortium and perform administrative functions under this subcha…

Sec. 491.053. PROVISION OF INVESTIGATIONAL SUN PROTECTION PRODUCT. (a) A manufacturer of an investigational sun protection product may make available in accordance with this chapter and any rules adopted under this chapter the manufacturer's product to eligible patients who provi…

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. 491.053. CONSORTIUM PROPOSAL. (a) The lead institution of higher education of a consortium shall submit to the commission a proposal and request for funding on behalf of the consortium for purposes of conducting ibogaine drug development clinical trials in accordance with th…

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. 491.054. COMMISSION SELECTION. The commission, in the commission's sole discretion, shall select a consortium established in accordance with Section 491.051 for the purpose of conducting ibogaine drug development clinical trials under this subchapter. Added by Acts 2025, 89t…

Sec. 491.054. NO CAUSE OF ACTION CREATED. This chapter does not create a private or state cause of action against a manufacturer of an investigational sun protection product or against any other person or entity involved in the care of an eligible patient using the product for an…

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. 491.055. CONTRACT WITH LEAD INSTITUTION. (a) As soon as practicable after selecting a consortium to conduct ibogaine drug development clinical trials under Section 491.054, the commission shall enter into an interagency contract, as provided by Chapter 771, Government Code, …

Sec. 491.055. STATE MAY NOT INTERFERE WITH ACCESS TO INVESTIGATIONAL SUN PROTECTION PRODUCTS. An official, employee, or agent of this state may not block or attempt to block an eligible patient's access to an investigational sun protection product under this chapter. Added by Act…

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. 491.056. INVESTIGATIONAL NEW DRUG APPLICATION. On the commission's notification that a consortium is selected to conduct the drug development clinical trials under this subchapter, a drug developer or hospital member of the selected consortium or the lead institution of high…

Sec. 491.057. DRUG DEVELOPMENT CLINICAL TRIAL SITES. For purposes of conducting a drug development clinical trial under this subchapter, only an institution of higher education or a hospital may serve as a trial site. Added by Acts 2025, 89th Leg., R.S., Ch. 333 (S.B. 2308), Sec.…

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. 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 2025, 89th Leg., R.S., Ch. 352 (S.B. 670), Sec. 2, eff. June 20, 2025. SUBCHAPTER…

Sec. 491.101. APPLICABILITY. This subchapter applies only if ibogaine is approved by the United States Food and Drug Administration to treat a medical condition. Added by Acts 2025, 89th Leg., R.S., Ch. 333 (S.B. 2308), Sec. 1, eff. June 11, 2025.

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. 491.102. MEDICAL SUPERVISION. A physician licensed under Subtitle B, Title 3, Occupations Code, who has prescribed ibogaine for a patient shall supervise the administration of ibogaine at a hospital or other licensed health care facility to ensure the patient's safety while …

Sec. 491.103. ADMINISTRATION UNDER FEDERAL LAW. This subchapter does not preclude a physician from administering ibogaine in accordance with federal law. Added by Acts 2025, 89th Leg., R.S., Ch. 333 (S.B. 2308), Sec. 1, eff. June 11, 2025.

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 PHYSICIAN'S LICENSE. 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. 491.151. 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…