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RSA 126-Z:1 · Definitions

Title: X: PUBLIC HEALTH
Chapter: 126-Z · RIGHT TO TRY ACT
Status: current
Official source linked: Yes

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126-Z:1 Definitions. – In this chapter:

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"Eligible facility" means a licensed New Hampshire institution that is operating under a Federalwide Assurance ("FWA") for the Protection of Human Subjects under 42 U.S.C. section 289(a) and 45 C.F.R. part 46. Any eligible facility is subject to the FWA laws, regulations, policies, and guidelines including renewals or updates. I-a. "Eligible patient" means a person to whom all of the following apply:

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(a)

The person has been diagnosed with a terminal illness by the person's physician.

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(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.

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(c)

The person is unable to participate in a clinical trial involving the eligible investigational drug, biologic or device.

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(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.

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(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. I-b. "Health care provider" means a physician licensed to practice medicine in the state of New Hampshire. I-c. "Individualized investigational treatment" means drugs, biologics, or devices unique to and produced exclusively for use for an individual patient, based on their own genetic profile, including but not limited to individualized gene therapy antisense oligonucleotides (ASO), individualized neoantigen vaccines, and any other individualized treatment.

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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 under investigation in a clinical trial. II-a. "Other protected access" includes:

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(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

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(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.

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III.

"Physician" means the licensed allopathic or osteopathic physician who is providing medical care or treatment to the eligible patient for the terminal illness.

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IV.

"Remote signing" means the signing of any form, witnessed by a notary public or a licensed health care provider, providing written informed consent for a person diagnosed by a physician with a terminal illness to participate in a clinical trial or receive a drug, biologic, or device, by the patient or, if the patient is a minor or lacks the mental capacity to provide consent, by a parent or legal guardian on the patient's behalf.

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"Telehealth prescreening" means any remote, real-time discussion intended, in part, to determine whether a person with a terminal illness may be:

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(a)

Ineligible for or not selected to participate in a clinical trial; or

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(b)

Ineligible to receive or not be offered a drug, biologic, or device.

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VI.

"Terminal illness" means diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted, and diseases or conditions with potentially fatal outcomes, where the endpoint of a clinical trial analysis is survival, which is the definition of "life threatening" under 21 C.F.R. section 312.81. Source. 2016, 206:2, eff. June 6, 2016. 2024, 124:1, eff. Jan. 1, 2025. 2025, 304:2, eff. Jan. 1, 2026.

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Source note

Source. 2016, 206:2, eff. June 6, 2016. 2024, 124:1, eff. Jan. 1, 2025. 2025, 304:2, eff. Jan. 1, 2026.

Source history

2016, 206:2, eff. June 6, 2016
2024, 124:1, eff. Jan. 1, 2025
2025, 304:2, eff. Jan. 1, 2026

Related materials

Bill relationships

2026 HB1292 amend · effective 2027-01-01
l and qualifying severe illness. This chapter shall be construed consistently with the general court's stated purpose. 5 New Section; Regenerative Stem Cell Therapies. Amend RSA 126-Z by inserting after section 8 the following new section: 126-Z:9 Regenerative Stem Cell Therapies. I. A physician may perform stem cell therapy that is not approved by the United States Food and Drug Administrati
2026 HB1292 amend · effective 2027-01-01
lls, tissues, or cellular or tissue-based products, the state will advance regenerative medicine in a manner consistent with the values of this state. 2 Right to Try Act. Amend RSA 126-Z:1 through 126-Z:4 to read as follows: 126-Z:1 Definitions. In this chapter: I. "Eligible facility" means a licensed New Hampshire institution that is operating under a Federalwide Assurance ("FWA") for the Protec
2026 HB1292-FN amend · effective 2027-01-01
lls, tissues, or cellular or tissue-based products, the state will advance regenerative medicine in a manner consistent with the values of this state. 2 Right to Try Act. Amend RSA 126-Z:1 through 126-Z:4 to read as follows: 126-Z:1 Definitions. In this chapter: I. "Eligible facility" means a licensed New Hampshire institution that is operating under a Federalwide Assurance ("FWA") for the Protec
2026 HB1292-FN amend · effective 2027-01-01
l and qualifying severe illness. This chapter shall be construed consistently with the general court's stated purpose. 5 New Section; Regenerative Stem Cell Therapies. Amend RSA 126-Z by inserting after section 8 the following new section: 126-Z:9 Regenerative Stem Cell Therapies. I. A physician may perform stem cell therapy that is not approved by the United States Food and Drug Administrati
2026 HB1735 amend
tment of certain severe illness under the right to try act. Be it Enacted by the Senate and House of Representatives in General Court convened: 1 Right to Try Act. Amend RSA 126-Z:1 through 126-Z:4 to read as follows: 126-Z:1 Definitions. In this chapter: I. "Eligible facility" means a licensed New Hampshire institution that is operating under a Federalwide Assurance ("FWA") for the Protec
2026 HB1735-FN amend
tment of certain severe illness under the right to try act. Be it Enacted by the Senate and House of Representatives in General Court convened: 1 Right to Try Act. Amend RSA 126-Z:1 through 126-Z:4 to read as follows: 126-Z:1 Definitions. In this chapter: I. "Eligible facility" means a licensed New Hampshire institution that is operating under a Federalwide Assurance ("FWA") for the Protec
2026 HB1809 reference · effective 2030-11-01
ryptamine, found in certain mushrooms, but does not include synthetic or synthetic analogs of psilocybin. VI. “Qualifying patient” means a patient whom a provider, as defined by RSA 126-ZZ:1, II, has diagnosed a medically appropriate candidate for the use of medical psilocybin based on being diagnosed with a qualifying condition. VII. “Qualifying condition” means any of the following: (a) Major treat
2026 HB1809-FN reference · effective 2030-11-01
ryptamine, found in certain mushrooms, but does not include synthetic or synthetic analogs of psilocybin. VI. “Qualifying patient” means a patient whom a provider, as defined by RSA 126-ZZ:1, II, has diagnosed a medically appropriate candidate for the use of medical psilocybin based on being diagnosed with a qualifying condition. VII. “Qualifying condition” means any of the following: (a) Major treat
2026 SB504 amend · effective 2027-01-01
ith all review and patient protection standards described therein, it shall not be required to obtain a license except as provided in that chapter. 17 Right to Try Act. Amend RSA 126-Z:1 through 126-Z:4 to read as follows: 126-Z:1 Definitions. In this chapter: I. "Eligible facility" means a licensed New Hampshire institution that is operating under a Federalwide Assurance ("FWA") for the Protec
2026 SB504 reference · effective 2027-01-01
nt, if applicable, that patient is liable for treatment expenses; and (6) A prominent statement that the patient is seeking treatment from an experimental treatment center under RSA 126-ZZ. II. “Experimental treatment” means the provision of a medical intervention by a health care provider involving an investigational drug, biologic, or device that has successfully completed phase one of a clinical t
2026 SB504-FN amend · effective 2027-01-01
ith all review and patient protection standards described therein, it shall not be required to obtain a license except as provided in that chapter. 17 Right to Try Act. Amend RSA 126-Z:1 through 126-Z:4 to read as follows: 126-Z:1 Definitions. In this chapter: I. "Eligible facility" means a licensed New Hampshire institution that is operating under a Federalwide Assurance ("FWA") for the Protec
2026 SB504-FN reference · effective 2027-01-01
nt, if applicable, that patient is liable for treatment expenses; and (6) A prominent statement that the patient is seeking treatment from an experimental treatment center under RSA 126-ZZ. II. “Experimental treatment” means the provision of a medical intervention by a health care provider involving an investigational drug, biologic, or device that has successfully completed phase one of a clinical t