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10.62.37.00.htm 10.62.37.00. Title 10 MARYLAND DEPARTMENT OF HEALTH Subtitle 62 NATALIE M. LAPRADE MEDICAL CANNABIS COMMISSION Chapter 37 Edible Cannabis Products Authority: Health-General Article, §13-3301, 13-3307, 13-3309, 13-3313, and 13-3313.1, Annotated Code of Maryland
10.62.37.01.htm 10.62.37.01. 01 Definitions.. A. In this chapter, the following terms have the meanings indicated.. B. Terms Defined.. 1) “Approved source” means a source of:. a) Medical cannabis approved, licensed, and regulated by the Commission; or. b) Food ingredients regulated by an approving authority.. 2) “Approving authority” means the agency designated in the laws of Maryland, another state, or another country to license or permit a food processing plant.
10.62.37.02.htm 10.62.37.02. 02 Categorization as Edible Cannabis Products.. Food or a food ingredient that is mixed, infused, or comes into contact with medical cannabis is considered and regulated as an edible cannabis product under this chapter.
10.62.37.03.htm 10.62.37.03. 03 Issuance of Permit.. A. Before engaging in the business of possessing, processing, packaging, labeling, transferring, transporting, selling, or distributing to a dispensary edible cannabis products, a licensed processor shall obtain a permit from the Commission.B. To obtain a permit, a licensed processor shall:. 1) Submit a completed permit application;. 2) Pay the registration fee specified in COMAR 10.62.35;. 3) Establish and obtain Commission approval for ea
10.62.37.04.htm 10.62.37.04. 04 General Premises Requirements.. A. The premises and operations shall conform to all local zoning and planning requirements.. B. A permit to process edible cannabis products shall be conspicuously displayed at the premises.. C. No major renovation or modification to the premises may be undertaken unless the Commission:. 1) Has received notice in the form prescribed by the Commission; and. 2) Issues written approval for the renovation or modification.. D. The premises shall be
10.62.37.05.htm 10.62.37.05. 05 Receipt of Ingredients.. A. Ingredients and other supplies necessary to process edible cannabis products shall be received in a designated area identified in the standard operating procedures.B. This regulation does not apply to the receipt of medical cannabis, medical cannabis concentrates, or medical cannabis-infused products that are not intended to be used as an ingredient in edible caC. Each receiving area shall have a barrier that reasonably prevents the entry of:.
10.62.37.06.htm 10.62.37.06. 06 Storage of Ingredients and Edible Cannabis Products.. A. All ingredients and edible cannabis products shall be kept in a secure controlled environment that:1) Meets the requirements set forth in this chapter; and. 2) Is a dry storage area, refrigerated storage area, or freezer storage area.. B. Storage standard operating procedures shall preserve freshness, prevent contamination, and maintain cannabinoid content of any ingredients or edible cannabis products.
10.62.37.07.htm 10.62.37.07. 07 Equipment.. A. General Requirements.. 1) The permittee shall prevent any ingredient or edible cannabis product from coming into contact with a surface or substance other than a clean and sanitary surface or substance intended for food contact or incorporation into food.2) Any heating and cooling equipment in close contact with ingredients or edible cannabis products shall be:a) Food grade;. b) Approved for use in food processing areas; or.
10.62.37.08.htm 10.62.37.08. 08 Cleaning and Sanitation Procedures.. A. General Requirements.. 1) A permittee shall establish standard operating procedures for cleaning and sanitizing any surface, cookware, or equipment that comes into contact with ingredients or edible cannabis products that:a) Ensure proper sanitation throughout the premises;. b) Are available to each agent in a form the agent understands; and. c) Are approved by the Commission.. 2) Any surface that comes into contact with ingred
10.62.37.09.htm 10.62.37.09. 09 Agent Sanitation.. A. The permittee shall establish standard operating procedures, approved by the Commission, for all aspects of agent hygiene and sanitation to ensure that each agent:1) Practices good personal hygiene and does not contaminate ingredients or edible cannabis products;. 2) Wears clean outerwear and, if necessary, a hair or beard covering, or both;. 3) Wears gloves when handling any cannabis plant material or medical cannabis concentrate;. 4) If wearing gloves:.
10.62.37.10.htm 10.62.37.10. 10 Manufacture.. A. A permittee shall establish standard operating procedures to ensure the consistent and safe manufacture of edible cannabis products.B. A standard operating procedure for the manufacture of edible cannabis products shall:. 1) Be available to each agent in a form the agent understands;. 2) Accurately reflect the procedures used at the premises; and. 3) Be approved by the Commission.. C. Potentially hazardous edible cannabis products may not be manufactured u
10.62.37.11.htm 10.62.37.11. 11 Trade Secrets.. A. A permittee shall provide the Commission with the recipe for each edible cannabis product prior to offering the product for distribution or sale to a licensed dispensary.B. A permittee shall notify the Commission of any ingredient or recipe that the permittee considers a trade secret.C. The Commission shall maintain the confidentiality of trade secret information in accordance with State Government Article, §10-617, and Health-General Article, §21-259, Ann
10.62.37.12.htm 10.62.37.12. 12 Edible Cannabis Product Requirements.. A. General Requirements.. 1) A permittee shall obtain approval from the Commission for all edible cannabis products prior to offering the products for distribution or sale to a licensed dispensary by submitting a request in the perpetual inventory control system.2) A permittee seeking approval to offer an edible cannabis product shall submit:. a) A photograph, digital image, or digital rendering of the product, labeling, and packaging;.
10.62.37.13.htm 10.62.37.13. 13 Edible Cannabis Packaging Requirements.. A. All edible cannabis product packaging shall comply with the requirements established in COMAR 10.62.24 and COMAR 10.62.29.B. Any container or packaging containing edible cannabis products shall protect the contents from contamination.C. Edible cannabis product packaging:. 1) Shall be designed and installed to maintain product safety and integrity;. 2) Shall be made from materials that are food safe, are appropriate for the
10.62.37.14.htm 10.62.37.14. 14 Edible Cannabis Product Labeling Requirements.. A. An edible cannabis product label shall comply with the requirements established in COMAR 10.62.24 and COMAR 10.62.29.B. An edible cannabis product label shall include:. 1) A list of:. a) Ingredients and sub-ingredients in descending order of prominence; and. b) Any natural or synthetic preservative added;. 2) A statement of any common food allergens, as indicated in the Food Allergen Labeling and Consumer Protection Act of 2004,
10.62.37.15.htm 10.62.37.15. 15 Limited Testing for Research and Development Purposes.. A. A licensed processor may process edible cannabis products for research and development purposes to facilitate safe edible cannabis product development and innovation.B. The research and development of the edible cannabis products under this regulation may not include testing of any type on human or animal subjects.C. Edible Cannabis Product Development. A licensed processor who processes edible cannabis products
10.62.37.16.htm 10.62.37.16. 16 Transport of Edible Cannabis Products.. A. The transport of edible cannabis products shall comply with the medical cannabis shipment requirements established in COMAR 10.62.18.B. If transporting edible cannabis products that require temperature control for safety and stability, a permittee shall ensure the vehicle or transportation equipment:1) Provides adequate temperature control to prevent the edible cannabis products from becoming unsafe during transport; and
10.62.37.17.htm 10.62.37.17. 17 Dispensary Responsibilities.. A. A licensed dispensary may not store or distribute edible cannabis products unless the licensed dispensary:1) Submits to the Commission the licensee’s standard operating procedures for receipt, storage, and distribution of all edible cannabis products; and2) Passes a Commission inspection, and the operations conform to the standard operating procedures for the receipt, storage, and distribution of all edible cannabis products.
10.62.37.18.htm 10.62.37.18. 18 Laboratory Testing.. A. Each lot of edible cannabis products shall be tested by a registered independent testing laboratory for:1) Cannabinoid content, including:. a) THC, which shall be +10 percent of any amount indicated on the edible cannabis product label;. b) Any other cannabinoids indicated in the Commission’s current version of technical authority; and. c) Any cannabinoid identified on the package or label of the edible cannabis product;.
10.62.37.19.htm 10.62.37.19. 19 Exceptions.. A licensee may not use an alternative method of receiving, storing, sanitizing, delivering, processing, monitoring, or verifying edible cannabis products or edible cannabis product equipment, cookware, or procedures unless authorized by the Commission.
10.62.37.20.htm 10.62.37.20. 20 Compliance with State and Federal Food Safety Requirements.. Although edible cannabis products are not defined as or regulated by the same approving authority as food, in addition to the other requirements set forth in this chapter, a permittee shall comply with all applicable food safety regulations including:A. 21 CFR, as amended;. B. 21 U.S.C. §343, as amended;. C. 21 U.S.C. §451―471, as amended; and. D. 21 U.S.C. §601―695, as amended..
10.62.37.21.htm 10.62.37.21. 21 Medical Cannabis Products and Components Not Subject to This Chapter.. A. Regulations .01―19 of this chapter do not apply to the following:. 1) Dried leaves and flowers of the cannabis plant;. 2) Medical cannabis concentrates; and. 3) Medical cannabis-infused products as defined in COMAR 10.62.23.01B(3)c). B. A licensed processor may submit a request to the Commission to exempt a medical cannabis product intended for human consumption by oral ingestion, in whole or part, from Re
10.62.37.9999.htm 10.62.37.9999. Administrative History Effective date: April 19, 2021 (48:8 Md. R. 309).
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