Utah Code 58-85-102. Definitions

As used in this chapter:

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

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(a)

meets the definition of "investigational device" in 21 C. See Utah Code 58-85-102

Investigational drug: means a drug that:

(a)

meets the definition of "investigational new drug" in 21 C. See Utah Code 58-85-102

Physician: means an individual who is licensed under:

(a)	Title 58, Chapter 67, Utah Medical Practice Act; or

(b)

Terminal illness: means a condition of a patient that:

(a)

as determined by a physician:

(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

(ii)	will inevitably lead to the patient's death; and

(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. See Utah Code 58-85-102 United States: includes each state, district, and territory of the United States of America. See Utah Code 68-3-12.5
(2)	“Insurer” means the same as that term is defined in Section 31A-1-301.

(3)

“Investigational device” means a device that:

(a)	meets the definition of “investigational device” in 21 C.F.R. § 812.3; and

(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:

(a)	meets the definition of “investigational new drug” in 21 C.F.R. § 312.3; and

(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 the same as that term is defined in Section 58-37-3.6.

(6)

“Physician” means an individual who is licensed under:

(a)	Title 58, Chapter 67, Utah Medical Practice Act; or

(b)	Title 58, Chapter 68, Utah Osteopathic Medical Practice Act.

(7)

“Terminal illness” means a condition of a patient that:

(a)

as determined by a physician:

(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

(ii)	will inevitably lead to the patient’s death; and

(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.

Amended by Chapter 1, 2018 Special Session 3