Missouri regulators have finalized rules creating a licensing framework for marijuana research facilities, allowing approved operators to conduct studies involving human and animal subjects, cultivation, genetics and marijuana products.
The rules appear in the October 1 edition of the Missouri Register, which was posted online ahead of its formal publication date. The regulations, 19 CSR 100-1.200, were adopted by the Missouri Division of Cannabis Regulation following a public rulemaking process that generated 35 comments.
Under the new framework, licensed research facilities will be authorized to cultivate marijuana, manufacture and process marijuana products, store products on-site and conduct research involving marijuana products.
Facilities may also conduct studies involving human and animal subjects and administer marijuana products to participants under approved research protocols.
For human studies, marijuana may be administered to adults 21 and older, as well as participants younger than 21 who have a medical marijuana patient identification card.
Human-subject studies must undergo review by both the department’s Institutional Review Board and an outside Institutional Review Board registered with the U.S. Department of Health and Human Services.
Each study must also have a licensed physician monitoring participants and a principal investigator with at least five years of experience conducting human-subject research.
Animal studies will require the research facility to maintain an animal welfare research registration with the U.S. Department of Agriculture and receive approval from an Institutional Animal Care and Use Committee in good standing with the National Institutes of Health Office of Laboratory Animal Welfare.
A licensed veterinarian must monitor the animals, and the principal investigator must have at least five years of experience conducting animal-subject research.
The rules also provide flexibility for plant and genetics research. Permitted activities can include developing, naming and tracking new marijuana strains, cultivars, phenotypes, chemotypes and genetic lines, as well as testing different cultivation variables and production methods.
Research facilities may acquire marijuana products from licensed cultivators and manufacturers, transfer products to testing laboratories or other research facilities, and sell or donate marijuana products to another licensed research facility.
They may also transfer seeds and clones developed through an approved research study to licensed cultivation facilities. Seeds may be acquired from entities outside Missouri’s regulated marijuana system when doing so does not violate state or federal law.
Research licensees may also contract with public institutions or other research facilities and may share space with licensed cultivation, manufacturing or testing facilities.
Obtaining a research license alone will not authorize a facility to begin conducting studies. Operators must first pass a commencement inspection and receive approval for a specific research study from the state.
Applications for a marijuana research facility license will carry a nonrefundable $500 fee, while each proposed research study will require a separate $250 application fee.
Study applications must include an abstract, research question, rationale, protocol, expected sample size and other information relevant to the proposed project.
The rules will take effect 30 days after publication in the Code of State Regulations.
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