Code of Massachusetts Regulations › 935 CMR - Cannabis Control Commission › Title 935 CMR 500.000 - Adult Use of Marijuana › Section 500.147 - Operational Requirements for Marijuana Research Facility Licensees and Research Permits

Current through Register 1525, July 5, 2024
(1) In addition to
			 the security requirements provided in
			 935 C
			 500.110, Marijuana Research Facility
			 Licensees shall comply with the operational requirements required under 935 CMR
			 500.147.
(2)
General
			 Requirements
(a) For each
			 research project to be conducted on the Premises, a Marijuana Research Facility
			 Licensee shall have a valid Research Permit issued by the Commission pursuant
			 to 935 CMR 500.147(4) prior to beginning a research project. The Research
			 Permit shall be renewed at least annually, or sooner depending on the nature
			 and duration of the approved research project.
(b) All individuals engaging in research at
			 the Marijuana Research Facility shall be registered with the Commission as
			 Marijuana Establishment Agents under
			 935 CMR
			 500.030.
(c) A Marijuana Research Facility Licensee
			 may submit an application for a Research Permit to conduct research in areas
			 including, but not limited to, the following:
1. Chemical potency and composition levels of
			 Marijuana and Marijuana Products;
2. Clinical investigations of Marijuana
			 Products, including dosage forms;
3. Efficacy and safety of administering
			 Marijuana or Marijuana Products as a component of medical treatment under the
			 supervision of a Certifying Healthcare Provider;
4. Genomic research on Marijuana;
5. Horticultural research on
			 Marijuana;
6. Agricultural research
			 on Marijuana; and
7. Other research
			 topics upon the approval of the Commission, provided however that research
			 conducted under the Marijuana Research Facility License may not be a substitute
			 for processes for drug approval established by the U.S. Food and Drug
			 Administration (FDA) pursuant to 21 CFR 312; and the Commission may impose
			 additional standards necessary to ensure the safety and efficacy of Marijuana
			 and Marijuana-derived compounds for their intended research
			 application.
(d)
			 Marijuana or Marijuana Products used in research conducted under a Marijuana
			 Research Facility License shall be cultivated by, produced by or acquired from
			 a licensed MTC or Marijuana Establishment authorized to cultivate, produce or
			 sell Marijuana or Marijuana Products, which includes a Marijuana Cultivator,
			 Marijuana Product Manufacturer, Marijuana Retailer, a Microbusiness or a Craft
			 Marijuana Cooperative. A Marijuana Research Facility Licensee not authorized to
			 cultivate its own Marijuana may enter into an agreement with a licensed MTC or
			 Marijuana Cultivator, Microbusiness or Craft Marijuana Cooperative to grow
			 Marijuana specifically for research.
(e) Any Marijuana or Marijuana Product
			 cultivated, produced or acquired for use in a Commission-approved research
			 project shall be entered by the Marijuana Establishment providing it to the
			 Marijuana Research Facility Licensee into the Seed-to-sale SOR in a form and
			 manner to be determined by the Commission.
(f) All Marijuana or Marijuana Products used
			 in research and consumed by human or animal subjects shall comply with the
			 following
1. Be adequately described in the
			 Informed Consent Form.
2. Tested in
			 accordance with
			 935 CMR
			 500.160 prior to consumption by human or
			 animal subjects.
(g) Any
			 research project where human research subjects are participants shall include
			 one or more licensed physicians in good standing to monitor the
			 participants.
(h) For any research
			 project other than a survey-only research project, human participants in
			 research conducted by a Marijuana Research Facility Licensee where consumption
			 of Marijuana or Marijuana Products is a component of the research project
			 design shall reside in the Commonwealth.
(i) Any research project where animal
			 research subjects are participants shall include one or more licensed
			 veterinary doctors in good standing to monitor the participants.
(j) For any research project other than a
			 survey-only research project, research conducted pursuant to a license granted
			 by the Commission shall be conducted solely within the boundaries of the
			 Commonwealth.
(k) A Marijuana
			 Research Facility Licensee shall supply the Commission with copies of all final
			 reports, findings or documentation regarding the outcomes of approved research
			 projects receiving a Research Permit. Any records received by the Commission
			 may be subject to release pursuant to the Public Records Law, M.G.L. c. 66,
			 § 10 and M.G.L. c. 4, § 7, cl. 26, or other compulsory legal process,
			 or at the Commission's discretion.