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006.02.7-14. Manufacturing and Processing of Medical Marijuana

AR ADC 006.02.7-14Arkansas Administrative Code

West's Arkansas Administrative Code
Title 006. Department of Finance and Administration
Division 02. Alcoholic Beverage Control
Rule 7. Rules Governing the Oversight of Medical Marijuana Cultivation Facilities, Processors and Dispensaries by the Alcoholic Beverage Control Division
Ark. Admin. Code 006.02.7-14
Formerly cited as AR ADC 006.02.7-12
006.02.7-14. Manufacturing and Processing of Medical Marijuana
Currentness
14.1 General Requirements for Manufacturing and Processing Medical Marijuana
a. Medical marijuana and medical marijuana products shall only be manufactured and processed in accordance with these rules;
b. All equipment, counters, and surfaces used for processing shall be food-grade and shall not react adversely with any solvent being used;
c. All counters and surfaces shall be constructed in a manner that reduce the potential for development of microbials, molds and mildews and that can be easily cleaned;
d. Every process lot shall be assigned a unique identification number that shall be entered into the Inventory Tracking System.
e. With the exception of medical marijuana, all ingredients used to make medical marijuana edibles must meet the requirements for food products set forth by the Food and Drug Administration and the Department.
14.2 General Prohibitions for Manufacturing and Processing Medical Marijuana
a. A cultivation facility, processor, or dispensary shall not process or manufacture a medical marijuana product in a non-child proof package or container:
i. That by its shape or design is likely to appeal to minors due to shape, color, taste or design, including but not limited to:
1. Products that are modeled after non-cannabis products primarily consumed by and marketed to children;
2. Products in the shape of an animal, vehicle, person, or character; and
3. Products that contain cannabinoid concentrates or extracts that, as determined by the Division closely resemble foods or beverages that are attractive to minors; and
a. that are commonly sold in retail establishments in individually packaged portions or multiple packs of individually packaged portions, regardless of whether the foods or beverages are generic, trademarked, or branded products, including, but without limitation to, candy, cookies, cakes, pastries, chewing gum and brownies;
ii. That is manufactured by applying cannabinoid concentrates or extracts to trademarked or branded food, candy, or beverages that are commercially available without cannabinoid concentrates or extracts and are commonly sold at retail establishments in individual portions or in multiple packs of individually packaged portions.
b. A cultivation facility, processor, or dispensary shall not treat or otherwise adulterate a cannabinoid product, concentrate, or extract with any non-cannabinoid additive that would increase potency, toxicity or addictive potential, or that would create an unsafe combination, with caffeine or other chemical that may increase carcinogenicity or cardiac effects.
c. A cultivation facility, processor, or dispensary is authorized to sell and possess hemp derived products so long as the product is clearly labeled “hemp derived” and does not violate the restrictions set forth in 14.2(b).
14.3 Manufacturing and Processing Policies and Procedures
a. Cultivation Facilities, processors, and dispensaries shall create and maintain written policies and procedures for the following:
i. Instructions for making each cannabinoid concentrate, extract, or product produced on the premises;
ii. Ingredients and amount of each ingredient used for each process lot;
iii. Process for making each product;
iv. Number of servings in a process lot;
v. Intended amount of THC per serving and in a unit of sale of the product; and
vi. Process for making each process lot homogenous.
b. Licensed facilities that manufacture and process cannabinoid concentrates or extracts shall create and maintain written policies and procedures regarding:
i. Procedures for conducting necessary safety checks prior to processing;
ii. Process for purging any solvent or other unwanted components from a cannabinoid concentrate or extract;
iii. Sanitization procedures for working surfaces and equipment;
iv. Procedures for handling or storage of any solvent, gas, or other chemical used in processing;
v. Quality control procedures; and
vi. Emergency procedures in case of a fire, chemical spill, or other emergency.
14.4 Manufacturing and Processing of Cannabinoid Edibles
Cultivation facilities and dispensaries manufacturing, and processing cannabinoid edibles shall comply with the following:
a. The requirements of this section, the requirements of rule 9.5 and rule 10.6;
b. Any state and local kitchen-related health and safety standards for retail food establishments;
c. Before sale, food or drink that has been combined with usable marijuana shall not exceed ten milligrams (10 mg) of active tetrahydrocannabinol per portion and shall be physically demarked; and
d. If the portions cannot be physically determined, the entirety of the food or drink that has been combined with usable marijuana shall not contain more than ten milligrams (10mg) of active tetrahydrocannabinol.
14.5 Manufacturing and Processing of Cannabinoid Concentrates and Cannabinoid Extracts.
a. Licensed facilities producing cannabinoid concentrates and extracts shall:
i. Not use solvent classified as “Class 1” by the Federal Drug Administration Guidance, Table 1, published in the Federal Register on December 24, 1997 (62 FR 67377);
ii. Only use a hydrocarbon-based solvent that is at least 99 percent purity;
iii. Only use a non-hydrocarbon-based solvent that is food-grade;
iv. Work in an environment with proper ventilation, controlling all sources of ignition where a flammable atmosphere is or may be present; and
v. Use only potable water and ice made from potable water in processing.
b. Licensed facilities producing cannabinoid extracts shall:
i. Not use pressurized canned flammable fuel, including but not limited to butane and other fuels intended for use in camp stoves, handheld torch devices, refillable cigarette lighters and similar consumer products;
ii. Process only in a fully enclosed room clearly designated on the floor plan of the licensed facility;
iii. Ensure that all processing rooms and equipment, including all electrical installations, comply with applicable electrical codes and fire codes;
iv. Use a professional grade closed loop extraction system designed to recover the solvents and built to recognized codes and generally accepted engineering standards, such as those of:
1. American National Standards Institute (ANSI);
2. Underwriters Laboratories (UL); or
3. The American Society for Testing and Materials (ASTM).
v. If using carbon dioxide in processing, use 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;
vi. Have equipment and facilities used in processing approved for use by the local fire code official;
vii. Have a licensed engineer certify that the closed-loop system was commercially manufactured, and is safe for its intended purposes;
viii. Have an emergency eye-wash station in any room in which cannabinoid extract is being processed; and
ix. Have all applicable material safety data sheets readily available in processing areas.
c. Licensed facilities producing cannabinoid concentrates may:
i. Use a mechanical extraction process;
ii. Use a chemical extraction process using a nonhydrocarbon-based or other solvent, such as water, vegetable glycerin, vegetable oils, animal fats, isopropyl alcohol or ethanol; and
iii. Use a chemical extraction process using the hydrocarbon-based solvent carbon dioxide, provided that the process does not involve the use of pressure or heat over 180 degrees.
d. Licensed facilities producing cannabinoid concentrates shall:
i. Not use denatured alcohol;
ii. Not apply pressure or heat over 180 degrees if using carbon dioxide; and
iii. Only use or store dry ice in a well-ventilated room to prevent against the accumulation of dangerous levels of carbon dioxide.

Credits

Adopted July 29, 2017. Amended July 16, 2020; May 30, 2022.
Current with amendments received through August 15, 2023. Some sections may be more current, see credit for details.
Ark. Admin. Code 006.02.7-14, AR ADC 006.02.7-14
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