{"data":{"id":"us-sd/sdcl-34-51-1","jurisdiction":"us-sd","citation":"SDCL § 34-51-1","heading":"Definitions.","body":"Terms used in this chapter mean:\n(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);\n(2) \"Eligible patient,\" an individual who has:\n(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;\n(b) Considered all other treatment options approved by the United States Food and Drug Administration;\n(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;\n(d) Given informed consent for the general or individualized investigative treatment; and\n(e) Documentation from the individual's treating physician that the individual meets the requirements of this chapter;\n(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;\n(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\n(5) \"Physician,\" any individual licensed pursuant to chapter 36-4.","path":["TITLE 34. PUBLIC HEALTH AND SAFETY","CHAPTER 34-51. INVESTIGATIONAL TREATMENTS"],"source_url":"https://sdlegislature.gov/Statutes/34-51-1","current_through":"2026-08-31","vintage":"","retrieved_at":"2026-09-03T15:18:57Z","sha256":"c5b1ec1faf9f7d0f90557887042a563913f016df412ab198834ab8cc11d21da2","source_id":"us-sd","stale":true,"prev":"us-sd/sdcl-34-50-6","next":"us-sd/sdcl-34-51-2"},"notice":"GroundRules: Original legal text. Not legal advice."}