In order for a patient to access an investigational drug, biological product, or device under this subchapter, a physician must document in the patient's medical record and chart that the patient:
(1) Has a terminal illness;
(2) Has a determination from a qualified physician that the patient has no comparable or satisfactory treatment options approved by the United States Food and Drug Administration available to treat the terminal illness and that the probable risk to the patient from the investigational drug, biological product, or device is not greater than the probable risk from the terminal illness;
(3) Has been unable to participate in a clinical trial for the terminal illness within one hundred (100) miles of the patient's home address or has not been accepted to the clinical trial within one (1) week of the completion of the clinical trial application process;
(4) Has been given a prescription by a physician for an investigational drug, biological product, or device;
(5) Has given informed consent in writing for the use of the investigational drug, biological product, or device.
(6) If the patient is a minor or lacks the mental capacity to provide informed consent, a parent or legal guardian may provide informed consent on the patient's behalf; and
(7) Has received written documentation from a physician that the patient meets the requirements of this subchapter.