Section 1.1 - Purpose and Scope(a) The purpose of this subchapter is to establish the requirements for a patient with a severe chronic disease to access and use an investigational drug, biological product, or device, consistent with Texas Health and Safety Code Chapter 490 and the rules in this subchapter.(b) Texas Health and Safety Code Chapter 490 and the rules in this subchapter do not require a manufacturer to make available an investigational drug, biological product, or device to an eligible patient but a manufacturer choosing to do so must not receive compensation.25 Tex. Admin. Code § 1.1
Adopted by Texas Register, Volume 49, Number 33, August 16, 2024, TexReg 6215, eff. 8/19/2024