Definitions.

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35-7-1802. Definitions.

(a) As used in this article:

(i) "Eligible patient" means a person who has:

(A) A terminal illness;

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

(C) Received a recommendation from a physician for an investigational drug, biological product or device;

(D) 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; and

(E) Documentation from a physician that the person meets 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 yet been approved for general use by the United States Food and Drug Administration and remains under investigation in a clinical trial;

(iii) "Terminal illness" means a disease that, without life-sustaining procedures, will soon result in death or a state of permanent unconsciousness from which recovery is unlikely.


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