- (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.
Source Note:The provisions of this §1.1 adopted to be effective August 19, 2024, 49 TexReg 6215.