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Agenda - Council Work Session - 04/11/2023
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Agenda - Council Work Session - 04/11/2023
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3/13/2025 11:12:17 AM
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Meetings
Meeting Document Type
Agenda
Meeting Type
Council Work Session
Document Date
04/11/2023
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APPENDIX <br />Repealed Minnesota Statutes: HO100-9 <br />(3) allow each oncologist (clinical investigator) in the state who meets or agrees to meet all <br />applicable federal requirements for investigational new drug research and who so requests to be <br />included in the research program as a clinical investigator to conduct the clinical trials; <br />(4) provide explanatory information and assistance to each clinical investigator in understanding <br />the nature of therapeutic use of THC within program requirements, including the informed consent <br />document contained in the protocol, informing and counseling patients involved in the program <br />regarding the appropriate use and the effects of therapeutic use of THC; <br />(5) apply to contract with the National Institute on Drug Abuse for receipt of dosage forms of <br />THC, fully characterized as to contents and delivery to the human system, pursuant to regulations <br />promulgated by the National Institute on Drug Abuse, and the federal Food and Drug Administration. <br />The principal investigator shall ensure delivery of the THC dosages to clinical investigators as <br />needed for participation in the program; <br />(6) conduct the research program in compliance with federal laws and regulations promulgated <br />by the federal Food and Drug Administration, the Drug Enforcement Administration, the National <br />Institute on Drug Abuse, and the purposes and provisions of this section; <br />(7) submit periodic reports as determined by the commissioner on the numbers of oncologists <br />and patients involved in the program and the results of the program; <br />(8) submit reports on intermediate or final research results, as appropriate, to the major scientific <br />journals in the United States; and <br />(9) otherwise comply with the provisions of this section. <br />Subd. 6. Exemption from criminal sanctions. For the purposes of this section, the following <br />are not violations under this chapter: <br />(1) use or possession of THC, or both, by a patient in the research program; <br />(2) possession, prescribing use of, administering, or dispensing THC, or any combination of <br />these actions, by the principal investigator or by any clinical investigator; and <br />(3) possession or distribution of THC, or both, by a pharmacy registered to handle Schedule I <br />substances which stores THC on behalf of the principal investigator or a clinical investigator. <br />THC obtained and distributed pursuant to this section is not subject to forfeiture under sections <br />609.531 to 609.5316. <br />For the purposes of this section, THC is removed from Schedule I contained in section 152.02, <br />subdivision 2, and inserted in Schedule II contained in section 152.02, subdivision 3. <br />Subd. 7. Citation. This section may be cited as the "THC Therapeutic Research Act." <br />152.22 DEFINITIONS. <br />Subdivision 1. Applicability. For purposes of sections 152.22 to 152.37, the terms defined in <br />this section have the meanings given them. <br />Subd. 2. Commissioner. "Commissioner" means the commissioner of health. <br />Subd. 3. Disqualifying felony offense. "Disqualifying felony offense" means a violation of a <br />state or federal controlled substance law that is a felony under Minnesota law, or would be a felony <br />if committed in Minnesota, regardless of the sentence imposed, unless the commissioner determines <br />that the person's conviction was for the medical use of cannabis or assisting with the medical use <br />of cannabis. <br />Subd. 4. Health care practitioner. "Health care practitioner" means a Minnesota licensed <br />doctor of medicine, a Minnesota licensed physician assistant, or a Minnesota licensed advanced <br />practice registered nurse who has the primary responsibility for the care and treatment of the <br />qualifying medical condition of a person diagnosed with a qualifying medical condition. <br />Subd. 5. Health records. "Health records" means health records as defined in section 144.2911 <br />subdivision 2, paragraph (c). <br />Subd. 5a. Hemp. "Hemp" has the meaning given to industrial hemp in section 18K.02, <br />subdivision 3. <br />Subd. 5b. Hemp grower. "Hemp grower" means a person licensed by the commissioner of <br />agriculture under chapter 18K to grow hemp for commercial purposes. <br />5R <br />
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