Rule 42.39.401 - MARIJUANA MANUFACTURER LICENSES - GENERAL PROVISIONS(1) A marijuana manufacturer license allows a marijuana manufacturer to convert or to compound marijuana into marijuana products. A marijuana manufacturer licensee may buy marijuana and marijuana products from licensed marijuana cultivators and licensed marijuana manufacturers and may sell marijuana products to licensed marijuana dispensaries.(2) The department shall begin accepting applications for marijuana manufacturers that are not former medical marijuana licensees, as defined in 16-12-102, MCA, on July 1, 2025. (3) Licensees will elect their tier level at their next renewal date and pay the fee provided in ARM 42.39.104.(4) A marijuana manufacturer licensee that manufactures above its licensure level may be subject to administrative proceedings. In determining whether a marijuana manufacturer licensee has manufactured above its licensure level, the department will determine the average amount of concentrate produced each month over the previous 12 months. (5) The licensed premises of a former medical marijuana licensee that is located in a red county is not eligible to apply to increase its licensure level until the local government approval process in 16-12-301, MCA, allows for marijuana manufacturing. (6) A marijuana manufacturer licensee must take all reasonable measures and precautions to ensure the following: (a) that the placement of equipment and storage of materials allow for the maintenance of sanitary operations for the manufacture of marijuana products; (b) that all surfaces, including utensils and equipment used for the preparation of marijuana products, shall be cleaned and sanitized as frequently as is necessary to protect against contamination; and (c) that the storage and transport of finished marijuana products shall be under conditions that will protect products against physical, chemical, and microbial contamination. (7) A marijuana manufacturer licensee must: (a) use equipment, counters, and surfaces for manufacturing that are food grade, do not react adversely with any solvent being used, reduce the potential for development of microbials, molds, and fungi, and can be easily cleaned; (b) maintain detailed instructions for making each infused product, concentrate, or extract, which shall be kept confidential by the department; (c) conduct necessary safety checks prior to commencing manufacturing; (d) use only potable water and ice made from potable water; and (e) provide hand-washing facilities designed to ensure that employee hands are not a source of contamination of marijuana-infused products, contact surfaces, or packaging materials used for marijuana-infused products. (8) A marijuana manufacturer licensee may not use: (a) pressurized, canned fuel intended for use in camp stoves, handheld torch devices, refillable cigarette lighters, and similar products; or(9) A marijuana manufacturer licensee may not manufacture, process, or offer for sale a synthetic marijuana product as defined in 16-12-102, MCA.(10) A marijuana manufacturer licensee must have current, written SOPs at the licensed premises and available for inspection for the following: (a) each category and type of marijuana product that it produces; (b) how all equipment, counters, and surfaces are thoroughly cleaned; (c) proper handling and storage of any solvent, gas, or other chemical used in processing or on the licensed premises; and (d) proper disposal of any waste produced during processing in accordance with ARM 42.39.310. (11) A marijuana manufacturer licensee and an employee of a marijuana manufacturer licensee may only transport marijuana and marijuana products that are in the licensee's seed-to-sale tracking system inventory in accordance with 16-12-222(4), MCA, and ARM 42.39.413(3) through (16) and may not transport the marijuana or marijuana products of other licensees without a marijuana transporter license.Mont. Admin. r. 42.39.401
NEW, 2021 MAR p. 1937, Eff. 1/1/2022; AMD, 2024 MAR p. 616, Eff. 3/23/2024AUTH: 16-12-112, MCA; IMP: 16-12-221, 16-12-222, MCA