<html xmlns="http://www.w3.org/1999/xhtml" lang="en-US"><head><meta charset="UTF-8"><meta http-equiv='content-language' content='en-us'/><title>SDLRC - Codified Law 34-51-1 - Definitions.</title><meta name="Generator" content="PowerTools for Open XML"><style>span { white-space: pre-wrap; } p.s8d681334002f464591a17930896a7984Normal { text-indent: 0.50in; text-align: justify; font-family: 'Times New Roman', 'serif'; font-size: 12pt; line-height: 108%; margin-top: 0; margin-left: 0; margin-right: 0; margin-bottom: .001pt; } span.s8d681334002f464591a17930896a7984SENU { font-family: 'Times New Roman', 'serif'; font-size: 12pt; font-style: normal; font-weight: bold; margin: 0; padding: 0; } span.s8d681334002f464591a17930896a7984CL { font-family: 'Times New Roman', 'serif'; font-size: 12pt; font-style: normal; font-weight: bold; margin: 0; padding: 0; } p.s8d681334002f464591a17930896a7984Statute { text-indent: 0.50in; text-align: justify; font-family: 'Times New Roman', 'serif'; font-size: 12pt; line-height: 108%; margin-top: 0; margin-left: 0; margin-right: 0; margin-bottom: .001pt; } span.s8d681334002f464591a17930896a7984DefaultParagraphFont { font-family: 'Times New Roman', 'serif'; font-size: 12pt; font-style: normal; font-weight: normal; margin: 0; padding: 0; } p.s8d681334002f464591a17930896a7984StatuteNumber1 { margin-left: 0.75in; text-indent: -0.50in; text-align: justify; font-family: 'Times New Roman', 'serif'; font-size: 12pt; line-height: 108%; margin-top: 0; margin-right: 0; margin-bottom: .001pt; } p.s8d681334002f464591a17930896a7984StatuteNumber2 { margin-left: 1.25in; text-indent: -0.50in; text-align: justify; font-family: 'Times New Roman', 'serif'; font-size: 12pt; line-height: 108%; margin-top: 0; margin-right: 0; margin-bottom: .001pt; } span.s8d681334002f464591a17930896a7984000000 { font-size: 12pt; font-style: normal; font-weight: normal; margin: 0; padding: 0; } p.s8d681334002f464591a17930896a7984NoIndent { text-indent: 0.00in; text-align: justify; font-family: 'Times New Roman', 'serif'; font-size: 12pt; line-height: 108%; margin-top: 0; margin-left: 0; margin-right: 0; margin-bottom: .001pt; } span.s8d681334002f464591a17930896a7984DefaultParagraphFont-000001 { font-family: 'Times New Roman', 'serif'; font-size: 12pt; font-style: normal; font-weight: bold; margin: 0; padding: 0; } span.s8d681334002f464591a17930896a7984SCL { font-family: 'Times New Roman', 'serif'; font-size: 12pt; font-style: normal; font-weight: normal; margin: 0; padding: 0; } body { text-decoration-skip-ink: none; } </style><meta name="viewport" content="width=device-width, initial-scale=1"><meta name="twitter:card" content="summary"><meta property="og:title" content="SD 34-51-1 - Definitions."><meta property="og:description" content="SDLRC Codified Law 34-51-1 - Definitions."><meta property="og:type" content="website"><meta property="og:url" content="https://sdlegislature.gov/Statutes/34-51-1"><meta property="og:image" content="https://lawmakerdocuments.blob.core.usgovcloudapi.net/photos/logoshape.webp"><meta property="og:site_name" content="South Dakota Legislature"></head><body><div><p dir="ltr" class="s8d681334002f464591a17930896a7984Normal"><a href="https://sdlegislature.gov/Statutes?Statute=34-51-1" rel="noopener"><span class="s8d681334002f464591a17930896a7984SENU">34-51-1</span></a><span xml:space="preserve" class="s8d681334002f464591a17930896a7984SENU">. </span><span class="s8d681334002f464591a17930896a7984CL">Definitions.</span></p><p dir="ltr" class="s8d681334002f464591a17930896a7984Statute"><span class="s8d681334002f464591a17930896a7984DefaultParagraphFont">Terms used in this chapter mean:</span></p><p dir="ltr" class="s8d681334002f464591a17930896a7984StatuteNumber1"><span class="s8d681334002f464591a17930896a7984DefaultParagraphFont">(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);</span></p><p dir="ltr" class="s8d681334002f464591a17930896a7984StatuteNumber1"><span class="s8d681334002f464591a17930896a7984DefaultParagraphFont">(2)    "Eligible patient," an individual who has:</span></p><p dir="ltr" class="s8d681334002f464591a17930896a7984StatuteNumber2"><span class="s8d681334002f464591a17930896a7984DefaultParagraphFont">(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;</span></p><p dir="ltr" class="s8d681334002f464591a17930896a7984StatuteNumber2"><span class="s8d681334002f464591a17930896a7984DefaultParagraphFont">(b)    Considered all other treatment options approved by the United States Food and Drug Administration;</span></p><p dir="ltr" class="s8d681334002f464591a17930896a7984StatuteNumber2"><span class="s8d681334002f464591a17930896a7984DefaultParagraphFont">(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;</span></p><p dir="ltr" class="s8d681334002f464591a17930896a7984StatuteNumber2"><span class="s8d681334002f464591a17930896a7984DefaultParagraphFont">(d)    Given informed consent for the general or individualized investigative treatment; and</span></p><p dir="ltr" class="s8d681334002f464591a17930896a7984StatuteNumber2"><span class="s8d681334002f464591a17930896a7984DefaultParagraphFont">(e)    Documentation from the individual's treating physician that the individual meets the requirements of this chapter;</span></p><p dir="ltr" class="s8d681334002f464591a17930896a7984StatuteNumber1"><span class="s8d681334002f464591a17930896a7984DefaultParagraphFont">(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;</span></p><p dir="ltr" class="s8d681334002f464591a17930896a7984StatuteNumber1"><span class="s8d681334002f464591a17930896a7984DefaultParagraphFont">(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</span></p><p dir="ltr" class="s8d681334002f464591a17930896a7984StatuteNumber1"><span xml:space="preserve" class="s8d681334002f464591a17930896a7984DefaultParagraphFont">(5)    "Physician," any individual licensed pursuant to chapter </span><a href="https://sdlegislature.gov/Statutes?Statute=36-4" rel="noopener"><span class="s8d681334002f464591a17930896a7984DefaultParagraphFont">36-4</span></a><span class="s8d681334002f464591a17930896a7984DefaultParagraphFont">.</span></p><p dir="ltr" class="s8d681334002f464591a17930896a7984Normal"><span xml:space="preserve" class="s8d681334002f464591a17930896a7984000000"> </span></p><p dir="ltr" class="s8d681334002f464591a17930896a7984NoIndent"><span xml:space="preserve" class="s8d681334002f464591a17930896a7984DefaultParagraphFont-000001">Source: </span><span class="s8d681334002f464591a17930896a7984SCL">SL 2015, ch 188, § 1; SL 2025, ch 144, § 1.</span></p></div></body></html>