GroundRules
Tex. Health and Safety Code § 491.056: INVESTIGATIONAL NEW DRUG APPLICATION.
Where this section sits in the code
- HEALTH AND SAFETY CODE
- TITLE 6. FOOD, DRUGS, ALCOHOL, AND HAZARDOUS SUBSTANCES
- SUBTITLE C. SUBSTANCE ABUSE REGULATION AND CRIMES Chapter 491, consisting of Secs. 491.001 to 491.103, was added by Acts 2025, 89th Leg., R.S., Ch. 333 (S.B. 2308), Sec. 1. For another Chapter 491, consisting of Secs. 491.001 to 491.151, added by Acts 2025, 89th Leg., R.S., Ch. 285 (S.B. 984), Sec. 1, see Sec. 491.001 et seq., post. For another Chapter 491, consisting of Secs. 491.001 to 491.151, added by Acts 2025, 89th Leg., R.S., Ch. 352 (S.B. 670), Sec. 2, see Sec. 491.001 et seq., post.
- CHAPTER 491. IBOGAINE TREATMENT
- SUBCHAPTER B. DRUG DEVELOPMENT OF IBOGAINE TREATMENT
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 higher education of the consortium, as specified by written agreement of the consortium members, shall, as soon as practicable:
(1) submit an investigational new drug (IND) application to the United States Food and Drug Administration in accordance with 21 C.F.R. Part 312; and
(2) seek a breakthrough therapy designation for ibogaine from the United States Food and Drug Administration under 21 U.S.C. Section 356.
Added by Acts 2025, 89th Leg., R.S., Ch. 333 (S.B. 2308), Sec. 1, eff. June 11, 2025.
Collected 2026-08-27T01:47:17Z. Source file · JSON