Availability of investigational drug, biological product or device; prohibition on preventing access to investigational drug, biological product or device; penalty.

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1. The manufacturer of an investigational drug, biological product or device may provide or make available the investigational drug, biological product or device to a patient in this State who has been diagnosed with a terminal condition if a physician has prescribed or recommended the investigational drug, biological product or device to the patient as authorized pursuant to NRS 630.3735 or 633.6945.

2. A manufacturer who provides or makes available an investigational drug, biological product or device to a patient pursuant to subsection 1 may:

(a) Provide the investigational drug, biological product or device to the patient without charge; or

(b) Charge the patient only for the costs associated with the manufacture of the investigational drug, biological product or device.

3. An officer, employee or agent of this State shall not prevent or attempt to prevent a patient from accessing an investigational drug, biological product or device that is authorized to be provided or made available to a patient pursuant to this section.

4. A violation of any provision of this section is a misdemeanor.

5. As used in this section:

(a) "Biological product" has the meaning ascribed to it in 42 U.S.C. § 262.

(b) "Investigational drug, biological product or device" means a drug, biological product or device that:

(1) Has successfully completed Phase 1 of a clinical trial;

(2) Has not been approved by the United States Food and Drug Administration; and

(3) Is currently being tested in a clinical trial that has been approved by the United States Food and Drug Administration.

(c) "Terminal condition" means an incurable and irreversible condition that, without the administration of life-sustaining treatment, will, in the opinion of the attending physician, result in death within 1 year.

(Added to NRS by 2015, 982)


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