50-12-104. Patient requirements. A patient is eligible for treatment with an investigational drug, biological product, or device if the patient has:

(1) considered all other treatment options currently approved by the United States food and drug administration;

(2) received a recommendation from the patient's treating health care provider for an investigational drug, biological product, or device;

(3) given written informed consent for the use of the investigational drug, biological product, or device; and

(4) documentation from the treating health care provider that the patient meets the requirements of this section.