§ 126-z-1

[RSA 126-Z:1 effective until January 1, 2025; see also RSA 126-Z:1 set out below.] 126-Z:1 Definitions. – In this chapter: I. 'Eligible patient' means a person to whom all of the following apply: (a) The person has a terminal illness as determined by the person's physician and a consulting physician. (b) The person's physician has determined that the person has no comparable or satisfactory United States Food and Drug Administration (FDA) approved treatment options available to diagnose, monitor, or treat the disease or condition involved and that the probable risk to the person from the investigational drug, biological product, or device is not greater than the probable risk from the disease or condition. (c) The person has received a prescription or recommendation from the person's physician for an investigational drug, biological product, or device. (d) The person has given written informed consent for the use of the investigational drug, biological product, or device or, if the patient is a minor or lacks the mental capacity to provide informed consent, a parent or legal guardian has given written informed consent on the patient's behalf.

gical product, or device or, if the patient is a minor or lacks the mental capacity to provide informed consent, a parent or legal guardian has given written informed consent on the patient's behalf. (e) The person has documentation from the person's physician that the person has met the requirements of this paragraph. II. 'Investigational drug, biological product, or device' means a drug, biological product, or device that has successfully completed phase one of a clinical trial, but has not been approved for general use by the FDA and remains under investigation in a clinical trial. III. 'Physician' means the licensed physician who is providing medical care or treatment to the eligible patient for the terminal illness. IV. 'Terminal illness' means a disease that, without life-sustaining procedures, will result in death in the near future or a state of permanent unconsciousness from which recovery is unlikely. [RSA 126-Z:1 effective January 1, 2025; see also RSA 126-Z:1 above.] 126-Z:1 Definitions. – In this chapter: I. 'Eligible patient' means a person to whom all of the following apply: (a) The person has been diagnosed by the person's physician with a life-threatening disease

:1 Definitions. – In this chapter: I. 'Eligible patient' means a person to whom all of the following apply: (a) The person has been diagnosed by the person's physician with a life-threatening disease or condition. (b) The person has already tried or is not a candidate for eligible United States Food and Drug Administration (FDA) approved treatment options for their disease or condition. (c) The person is unable to participate in a clinical trial involving the eligible investigational drug, biologic or device. (d) The person has given written informed consent for the use of the investigational drug, biological product, or device or, if the patient is a minor or lacks the mental capacity to provide informed consent, a parent or legal guardian has given written informed consent on the patient's behalf. (e) The physician providing access to an investigational drug, biologic, or device will not be compensated directly by the manufacturer for providing access to this therapy. II. 'Investigational drug, biologic, or device' means a drug, biologic, or device that has successfully completed phase one of a clinical trial, but has not been approved for general use by the FDA and remains

tigational drug, biologic, or device' means a drug, biologic, or device that has successfully completed phase one of a clinical trial, but has not been approved for general use by the FDA and remains under investigation in a clinical trial. II-a. 'Life-threatening disease' means: (a) Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted; and (b) Diseases or conditions with potentially fatal outcomes, where the end point of clinical trial analysis for new drugs, biologics, or devices for that disease or condition is survival. II-b. 'Other protected access' includes: (a) 'Expanded access' whereby the treating physician requests access to an investigational drug, biologic, or device from the FDA and is subject to oversight from an Institutional Review Board; and (b) 'Off-label use' means prescribing an FDA approved drug, biologic, or device for a use not approved for that specific indication consistent with RSA 329:17, VI-b. III. 'Physician' means the licensed physician who is providing medical care or treatment to the eligible patient for the terminal illness. Source. 2016, 206:2, eff. June 6, 2016. 2024, 124:1, eff. Jan.

I. 'Physician' means the licensed physician who is providing medical care or treatment to the eligible patient for the terminal illness. Source. 2016, 206:2, eff. June 6, 2016. 2024, 124:1, eff. Jan. 1, 2025.