25 Tex. Admin. Code § 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.
Notes
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