126-Z:1 Definitions. –
In this chapter:
I. "Eligible patient" means a person to whom all of the following apply:
(a) The person has a terminal illness as determined by the person's physician and a consulting physician.
(b) The person's physician has determined that the person has no comparable or satisfactory United States Food and Drug Administration (FDA) approved treatment options available to diagnose, monitor, or treat the disease or condition involved and that the probable risk to the person from the investigational drug, biological product, or device is not greater than the probable risk from the disease or condition.
(c) The person has received a prescription or recommendation from the person's physician for an investigational drug, biological product, or device.
(d) The person has given written informed consent for the use of the investigational drug, biological product, or device or, if the patient is a minor or lacks the mental capacity to provide informed consent, a parent or legal guardian has given written informed consent on the patient's behalf.
(e) The person has documentation from the person's physician that the person has met the requirements of this paragraph.
II. "Investigational drug, biological product, or device" means a drug, biological product, or device that has successfully completed phase one of a clinical trial, but has not been approved for general use by the FDA and remains under investigation in a clinical trial.
III. "Physician" means the licensed physician who is providing medical care or treatment to the eligible patient for the terminal illness.
IV. "Terminal illness" means a disease that, without life-sustaining procedures, will result in death in the near future or a state of permanent unconsciousness from which recovery is unlikely.