South Dakota § 34-51-1 - Definitions.

Full text of South Dakota South Dakota Codified Laws § 34-51-1 — Definitions., with citation guidance and answers to common questions.

§ 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.

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

Frequently Asked Questions About South Dakota § 34-51-1

What does South Dakota Codified Laws § 34-51-1 cover?

Section 34-51-1 ("Definitions.") is part of the South Dakota Codified Laws, the codified statutory law of South Dakota. It sets out the legal rule or procedure described in the text above. Statutes are amended regularly, so always verify against the official source.

How do I cite South Dakota § 34-51-1?

A common citation format is "South Dakota Codified Laws § 34-51-1" (South Dakota). Legal writing may require the code abbreviation, section number, and year or edition. Match the style required by your court, professor, or publisher.

Is this the official text of South Dakota law?

No. This page is for research and education and may not include the most recent amendments. For official current law, check the South Dakota official source linked on this page or consult a licensed South Dakota attorney.

How does South Dakota § 34-51-1 apply to my situation?

Statutes are interpreted in context, and application depends on your specific facts. Only a licensed attorney in South Dakota can advise on how this section applies to you. Contact your state or local bar association for a referral.

Sources & Verification

Not legal advice. Verify against the official source and consult a licensed attorney in South Dakota.