Terms used in this chapter mean:
(1) "Eligible facility," an institution operating under a federalwide assurance for the protection of human subjects, pursuant to 45 C.F.R. Part 46 (January 1, 2025);
(2) "Eligible patient," an individual who has:
(a) A disease or condition that is life-threatening or severely debilitating, as those terms are defined in 21 C.F.R § 312.81 (January 1, 2025), attested by the patient's treating physician;
(b) Considered all other treatment options approved by the United States Food and Drug Administration;
(c) Received a recommendation from the individual's treating physician for a general investigative treatment, or an individualized investigative treatment based on an analysis of the individual's genomic sequence, human chromosomes, deoxyribonucleic acid, ribonucleic acid, genes, gene products, or metabolites;
(d) Given informed consent for the general or individualized investigative treatment; and
(e) Documentation from the individual's treating physician that the individual meets the requirements of this chapter;
(3) "General investigative treatment," any 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 approved by the United States Food and Drug Administration;
(4) "Individualized investigative treatment," any drug, biological product, or device, from a manufacturer operating within an eligible facility, which is unique to and produced exclusively for an individual patient's use based on the patient's genetic profile; and
(5) "Physician," any individual licensed pursuant to chapter 36-4.