(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(14), MCA, on July 1, 2023.
(3) A licensee may continue to operate under their existing marijuana-infused products provider license and may apply for a marijuana manufacturer license at their next renewal date.
(4) Licensees will elect their tier level at their next renewal date and pay the fee provided in ARM 42.39.102.
(5) 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.
(6) 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.
(7) 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;
(c) that the water supply is safe and potable; and
(d) that the storage and transport of finished marijuana products shall be under conditions that will protect products against physical, chemical, and microbial contamination.
(8) 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; and
(c) conduct necessary safety checks prior to commencing processing.
(9) 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 (10)(b);
(b) only use nonhydrocarbon-based solvents that are food grade;
(c) use only potable water and ice made from potable water;
(d) use a professional grade closed-loop extraction system designed to recover the solvents;
(e) have equipment used in processing approved for use by the fire official having jurisdiction over the licensed premises;
(f) have an emergency eye-wash station in any room in which chemical manufacturing is occurring; and
(g) have all applicable safety data sheets readily available.
(10) A marijuana manufacturer licensee that engages in chemical manufacturing may use:
(a) a mechanical and/or physical extraction process;
(b) 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
(c) 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 six hundred pounds per square inch.
(11) A marijuana manufacturer licensee that engages in chemical manufacturing may not use:
(a) 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;
(b) pressurized, canned fuel intended for use in camp stoves, handheld torch devices, refillable cigarette lighters, and similar products; or
(c) denatured alcohol.
(12) A marijuana manufacturer licensee shall not utilize a branded, commercially manufactured food product (e.g., Chex Mix, Nerds Ropes) as an edible marijuana product except when commercially manufactured food products are used as ingredients in an edible marijuana product in a way that renders them unrecognizable as the commercial food product in the final edible marijuana product; and the licensee does not state or advertise to the consumer that the final edible marijuana product contains the commercially manufactured food product.
(13) A marijuana manufacturer licensee may not infuse any food with marijuana that requires heated, time-temperature control or a hot holding unit to keep it safe for human consumption and may not serve hot or heated foods that promote onsite consumption.
(14) Any foods that require refrigeration or freezing to keep them safe for human consumption must be stored in a refrigerator or freezer until the time of sale and must be affixed with a label that indicates the product must be kept refrigerated or frozen, as appropriate.
(15) A marijuana manufacturer licensee may not treat or otherwise alter a marijuana product with any synthetic cannabinoid additive, including Delta-8 tetrahydrocannabinol, that would increase potency, toxicity, or addictive potential.
(16) A marijuana manufacturer licensee must have current, written standard operating procedures at the licensed premises and available for inspection for the following:
(a) each category and type of marijuana product that it produces;
(b) cleaning all equipment, counters, and surfaces thoroughly;
(c) proper handling and storage of any solvent, gas, or other chemical used in processing or on the licensed premises;
(d) proper disposal of any waste produced during processing; and
(e) training employees on how to use the closed-loop system and handle and store the solvents and gasses safely.
(17) A marijuana manufacturer licensee and an employee of a marijuana manufacturer licensee may transport their marijuana and marijuana products in accordance with 16-12-222(4), MCA, and ARM 42.39.413(4) through (15) but may not transport the marijuana or marijuana products of other licensees without a marijuana transporter license.