Utah § 58-85-102 Definitions.

Utah Statutes

§ 58-85-102 — Definitions.

Utah·Title 58 Occupations and Professions·Ch. 58-85 Utah Right to Try Act

As used in this chapter:

(1)"Eligible patient" means an individual who has been diagnosed with a terminal illness by a physician.

(2)"Insurer" means the same as that term is defined in Section 31A-1-301.

(3)"Investigational device" means a device that:

(3)(a) meets the definition of "investigational device" in 21 C.F.R. Sec. 812.3; and

(3)(b) has successfully completed the United States Food and Drug Administration Phase 1 testing for an investigational device described in 21 C.F.R. Part 812.

(4)"Investigational drug" means a drug that:

(4)(a) meets the definition of "investigational new drug" in 21 C.F.R. Sec. 312.3; and

(4)(b) has successfully completed the United States Food and Drug Administration Phase 1 testing for an investigational new drug described in 21 C.F.R. Part 312.

(5)

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As used in this chapter:
(1) "Eligible patient" means an individual who has been diagnosed with a terminal illness by a physician.
(2) "Insurer" means the same as that term is defined in Section 31A-1-301.
(3) "Investigational device" means a device that:
(3)(a) meets the definition of "investigational device" in 21 C.F.R. Sec. 812.3; and
(3)(b) has successfully completed the United States Food and Drug Administration Phase 1 testing for an investigational device described in 21 C.F.R. Part 812.
(4) "Investigational drug" means a drug that:
(4)(a) meets the definition of "investigational new drug" in 21 C.F.R. Sec. 312.3; and
(4)(b) has successfully completed the United States Food and Drug Administration Phase 1 testing for an investigational new drug described in 21 C.F.R. Part 312.
(5) "Medicinal dosage form" means:
(5)(a) a tablet;
(5)(b) a capsule;
(5)(c) a concentrated oil;
(5)(d) a liquid suspension;
(5)(e) a transdermal preparation; or
(5)(f) a sublingual preparation.
(6) "Physician" means an individual who is licensed under:
(6)(a) Title 58, Chapter 67, Utah Medical Practice Act; or
(6)(b) Title 58, Chapter 68, Utah Osteopathic Medical Practice Act.
(7) "Terminal illness" means a condition of a patient that:
(7)(a) as determined by a physician:
(7)(a)(i) is likely to pose a greater risk to the patient than the risk posed to the patient by treatment with an investigational drug or investigational device; and
(7)(a)(ii) will inevitably lead to the patient's death; and
(7)(b) presents the patient, after the patient has explored conventional therapy options, with no treatment option that is satisfactory or comparable to treatment with an investigational drug or device.