Section 1.3 - Patient Eligibility(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) the patient's treating physician confirms, in writing, the patient has a diagnosis of a severe chronic disease; and(2) the patient signs a written informed consent as described in §1.4 of this subchapter (relating to Informed Consent).(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.25 Tex. Admin. Code § 1.3
Adopted by Texas Register, Volume 49, Number 33, August 16, 2024, TexReg 6215, eff. 8/19/2024