Rule 42.39.402 - MARIJUANA MANUFACTURER LICENSE - CHEMICAL MANUFACTURING(1) A marijuana manufacturer licensee that applies to engage in chemical manufacturing must indicate that type of manufacturing activity on its initial license or license renewal application. There is no additional cost for a marijuana manufacturer licensee who elects a chemical manufacturing designation on its initial license or license renewal application.(2) A marijuana manufacturer licensee that engages in chemical manufacturing must: (a) use only hydrocarbon-based solvents that are at least 99 percent pure, except when using solvents outlined in (3)(a);(b) only use food grade nonhydrocarbon-based solvents, such as water, vegetable glycerin, vegetable oils, or animal fats;(c) use a professional grade, closed-loop extraction system designed to recover the solvents;(d) have processing equipment approved for use by the fire code official with jurisdiction over the licensed premises;(e) have an emergency eye-wash station in any room in which chemical manufacturing is occurring;(f) have all applicable safety data sheets readily available at the licensed premises; and(g) have a current, written standard operating procedure available for inspection at the licensed premises that details employee training on closed-loop extraction system operation and proper handling of solvents and gasses used in processing or stored on the licensed premises.(3) A marijuana manufacturer licensee that engages in chemical manufacturing may use: (a) a chemical extraction process using a nonhydrocarbon-based or other solvent, such as water, vegetable glycerin, vegetable oils, animal fats, isopropyl alcohol, or ethanol; or(b) a chemical extraction process using the solvent carbon dioxide, provided that the process: (i) does not involve the use of heat over 180 degrees Fahrenheit; and(ii) uses a professional grade closed-loop carbon dioxide gas extraction system where every vessel is rated to a minimum of 600 pounds per square inch.(4) A marijuana manufacturer licensee that engages in chemical manufacturing may not use class 1 solvents according to the Q3 Tables and List Guidance for Industry published by the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research.Mont. Admin. r. 42.39.402
NEW, 2024 MAR p. 616, Eff. 3/23/2024AUTH: 16-12-104, 16-12-112, 16-12-221, MCA; IMP: 16-12-104, 16-12-109, 16-12-112, 16-12-201, 16-12-203, 16-12-207, 16-12-208, 16-12-210, 16-12-221, 16-12-301, MCA