§ 34-51-1 — Definitions.

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 .

Legislative History

SL 2015, ch 188, § 1; SL 2025, ch 144, § 1.