1. (a) A patient is eligible to access and use an investigational drug, biological product, or device, consistent with Texas Health and Safety Code §490.001, if:

   1. (1) the patient's treating physician confirms, in writing, the patient has a diagnosis of a severe chronic disease; and
   2. (2) the patient signs a written informed consent as described in §1.4 of this subchapter (relating to Informed Consent).
2. (b) A treating physician must maintain the written confirmation of a patient's severe chronic disease diagnosis in the medical record of the treating physician in accordance with the applicable records retention requirements.

Source Note:The provisions of this §1.3 adopted to be effective August 19, 2024, 49 TexReg 6215.