In this chapter, the following terms have the meanings indicated. Terms Defined. “Current Good Manufacturing Practices” or “cGMP” means a manufacturing process that complies with 21 CFR Part 111 or 21 CFR Part 210. “Food” means any substance that is used as food or drink for human beings or as a component of food or drink for human beings. “Food ingredient” means a substance that is used as a component of food, including: Flavoring; Food coloring; and Preservatives. “Ingredient” means any component of an edible cannabis product that is intended for human consumption, approved by the Administration, and composed of: Food or food ingredients; or Cannabis. “Permittee” means a licensed processor authorized by the Administration to manufacture edible cannabis products. A dispensary is only authorized to dispense a finished product that has been sealed, labeled, and packaged in accordance with COMAR 14.17.18. Except as described in Regulation .11 of this chapter, a dispensary shall only obtain finished cannabis products from a licensed grower or processor. Medical Cannabis Products. The Administration shall require that certain finished cannabis products be dispensed only to qualifying patients or registered caregivers to: Ensure adequate supply of medical cannabis products; and Reserve high potency products for medical patients. No part of this section may be construed to prohibit the dispensing of other finished cannabis products to qualifying patients in accordance with COMAR 14.17.12.04, including: Cannabis vaporizing devices; Home cultivation products; Usable cannabis products; and Edible cannabis products containing less than: 10 milligrams of tetrahydrocannabinol per serving; or 100 milligrams of tetrahydrocannabinol per package. Adult-Use Cannabis Products. Individuals purchasing cannabis products for adult-use may purchase: Cannabis vaporizing devices; Concentrated cannabis products with a total weight of 1 gram or less; Home cultivation products; Usable cannabis products; Infused non-edible cannabis products; and Edible cannabis products, tinctures, and capsules containing equal to or less than: 10 milligrams of tetrahydrocannabinol per serving; and 100 milligrams of tetrahydrocannabinol per package. Infused pre-rolls are not subject to the weight limit in §B(2) of this regulation. Licensed dispensaries shall otherwise provide products for retail sale in accordance with COMAR 14.17.12.06. Finished cannabis products for retail sale shall be tested by an independent testing laboratory authorized by the Administration in accordance with COMAR 14.17.08 prior to any sale, distribution, or dispensing. Testing, sampling, and other laboratory protocols shall be performed by the independent testing laboratory in accordance with the Administration’s Technical Authority. General Requirements. Before engaging in the business of possessing, processing, packaging, labeling, transferring, transporting, selling, or distributing edible cannabis products to a dispensary, a licensed processor shall obtain a permit from the Administration in accordance with COMAR 14.17.11.05B. Prior to offering the products for distribution or sale to a licensed dispensary, a permittee shall obtain approval from the Administration for all edible cannabis products by submitting a request in in a manner prescribed by the Administration. A permittee seeking approval to offer an edible cannabis product shall submit: A photograph, digital image, or digital rendering of the product, labeling, and packaging; The varying levels of potency and dosing of the edible cannabis product; The recipe, including the production process, for manufacturing the edible cannabis product; and Any scientific studies or laboratory testing results supporting the stability and approximate expiration date of the edible cannabis product. The Administration shall review and approve each edible cannabis product before the product may be commercially manufactured or sold by a permittee, to ensure the: Product complies with the requirements of this chapter; and Safety of minors. Dosage Requirements. Unless expressly authorized by the Administration, an edible cannabis product may not contain more than: 10 milligrams of THC per serving; and 100 milligrams of THC per package. Each single serving contained in a package of a multiple-serving edible cannabis product shall be physically separated in a way that enables an individual to determine how much of the edible cannabis product constitutes a single serving. An intact product form containing multiple servings does not meet the requirements of §B(2) of this regulation if it has demarcations or delineations on the product to indicate individual servings. The Administration may approve a request to manufacture a high potency edible cannabis product containing more than 10 milligrams of THC per serving or 100 milligrams of THC per package if: A permittee submits a request in a form prescribed by the Administration; and The request complies with §G of this regulation. An edible cannabis product consisting of multiple servings shall be homogenized so that each serving contains the same concentration of THC. Appearance of Edible Cannabis Products. A permittee shall only manufacture or distribute solid edible cannabis product in geometric shapes. A permittee may not manufacture an edible cannabis product that due to its shape, design, or flavor is likely to appeal to minors. The manufacture or sale of edibles in the following shapes is prohibited: Human, animal, toy, or fruit; A shape that bears the likeness or contains characteristics of a realistic or fictional human, animal, or fruit, including artistic, caricature, or cartoon renderings; and A commercially available food or beverage product that targets or is primarily marketed to minors. Liquid Edible Product Requirements. A liquid edible product container may not contain more than a single serving per container. A single serving of a liquid edible product may not exceed 10 milligrams of THC per container. A liquid edible product shall otherwise comply with this regulation. Prohibited Products. Edible cannabis products may not contain: Meat; Seafood; Unpasteurized eggs; or Unpasteurized dairy of any type. The following types of products may not be sold: Alcoholic beverages, as defined in Alcoholic Beverage and Cannabis Article, §1-101, Annotated Code of Maryland; and Any product containing any non-cannabis additive that would increase potency or toxicity, or that would create an unsafe combination with other psychoactive substances, including nicotine and caffeine. The prohibition in §E(2)(b) of this regulation does not apply to products containing naturally occurring caffeine, such as coffee, tea, or chocolate. Compliance with State and Federal Food Safety Requirements. In addition to the other requirements set forth in this chapter, a permittee shall comply with all applicable food safety regulations, including: 21 CFR, as amended; 21 U.S.C. §343, as amended; 21 U.S.C. §§451—471, as amended; and 21 U.S.C. §§601—695, as amended. High Potency Edible Cannabis Products. Edible products produced with approval by the Administration under §B(4) of this regulation shall comply with Current Good Manufacturing Practices under 21 CFR Part 111 or 21 CFR Part 210. A permittee shall submit to the Administration a third-party certification that demonstrates compliance with §G(1) of this regulation. Demonstration of compliance required under §G(2) of this regulation shall include: Proof of the third party’s accreditation to certify for Current Good Manufacturing Practices that complies with 21 CFR Part 111 or 21 CFR Part 210; An attestation that the third party performed a facility audit of the licensed processor’s facility using an audit checklist within the scope of accreditation that complies with 21 CFR Part 111 or 21 CFR Part 210; The audit checklist for cGMP 21 CFR Part 111 or 21 CFR Part 210, facility score, the audit checklist score scale, and a corrective plan to remediate any deficiencies identified during the audit; and Documentation that the dosage form is recognized by the United States Pharmacopeia, the National Formulary, or the Food and Drug Administration. Edible products produced with approval by the Administration under §B(4) of this regulation may not contain more than: 40 milligrams of THC per serving; and 400 milligrams of THC per package. A dispensary shall only sell or dispense high potency edible products to qualified patients and registered caregivers. A processor shall label high potency edible products in accordance with COMAR 14.17.18.04. The Administration shall maintain permittee trade secrets in conformity with COMAR 14.17.11.05. A tincture shall: Contain no additional non-cannabis ingredients except potable water, unless approved by the Administration; and For vegetable oil tinctures, be manufactured in accordance with the regulation of edible cannabis products under Regulation .05E—H of this chapter and COMAR 14.17.11.05—.14, except for COMAR 14.17.11.05B; and Be dispensed in a container that: Has a resealing, child-resistant cap, or closure; and Includes a dropper measuring device within the package. A licensee is encouraged to manufacture varying levels of potency for each tincture or capsule product the permittee distributes, including products containing: 2.5 milligrams of THC per serving; and 5 milligrams of THC per serving. A dispensary shall only sell or dispense capsule and tincture products with more than 10 milligrams of tetrahydrocannabinol per serving and 100 milligrams tetrahydrocannabinol per package to qualifying patients or registered caregivers. A licensed dispensary is authorized to sell and distribute home cultivation products intended to assist with the home cultivation of cannabis. A licensed dispensary may sell up to: Two actively growing plants or seedlings to an adult use consumer; and Four actively growing plants or seedlings to a qualifying patient who is 21 years old or older or to a registered caregiver. Seedlings not sold by a dispensary shall be destroyed and recorded as green waste in accordance with standard operating procedures if the plant is: Taller than 8 inches; Wider than 8 inches; or Otherwise in a flowering or vegetative state. A licensed dispensary may not cultivate cannabis plants. A licensed dispensary shall only acquire home cultivation products under this regulation from a licensed grower. A dispensary may sell cannabis vaporizing devices to: Individuals 21 years old or older; or Registered patients and qualifying caregivers. A cannabis vaporizing device may include a cartridge containing a concentrated or infused cannabis liquid for the purposes of heating and producing a vapor. Except as authorized by COMAR 14.17.12.04, cannabis vaporizing devices may not include any solvent, solution, or other substance deemed to be a risk to public health or safety by the Administration. A dispensary may dispense infused non-edible products to qualifying patients, registered caregivers, or adult use consumers. A dispensary shall only sell or dispense concentrated cannabis products with a total weight that exceeds 1 gram to qualifying patients or registered caregivers. Concentrated cannabis products with a total weight that exceeds 1 gram shall be labeled in accordance with COMAR 14.17.18.04. Usable cannabis products may be sold to: Individuals 21 years old or older; or Qualifying patients and registered caregivers. A licensed dispensary may package, repackage, wrap, roll, or otherwise create usable cannabis products from usable cannabis in accordance with §§C and D of this regulation. Repackaging Requirements. Handwashing Sinks. A dispensary shall ensure that agents engaged in creating usable cannabis products have easy access to a handwashing sink that provides warm water of sufficient volume under pressure for effective handwashing procedures. A dispensary shall maintain at least one handwashing sink for the following number of agents who are engaged in repackaging while on duty at the same time: Every 15 agents; and Any fraction of 15 agents. Scales. A scale used by a licensed dispensary for the creation of usable cannabis products shall be: A National Type Evaluation Program approved device; Calibrated and recertified annually. A licensed dispensary shall make records and certifications required under §C(2)(a) of this regulation available to the Administration available upon request. Sanitation. Scales, surfaces, and other equipment use for the purposes of creating usable cannabis products shall be cleaned and sanitized: Between shifts; Between packaging, repackaging, or otherwise creation of usable cannabis products with different usable cannabis batches; Before beginning any packaging, repackaging, or otherwise creation of usable cannabis products; and After the completion of any packaging, repackaging, or otherwise creation of usable cannabis products. Licensed dispensaries shall maintain an accurate log of cleaning and sanitation required under §C(3)(a) of this regulation. Products produced by dispensaries under this regulation shall be packaged and labeled in accordance with COMAR 14.17.18. Transfer limits and Inventory Controls on Usable Cannabis. Usable cannabis transferred from a licensed grower to a licensed dispensary for the purposes of creation of usable cannabis products may not exceed: 1 pound in a single package; or 50 pounds in a single transfer. A licensed dispensary shall have no more than 50 pounds of usable cannabis in inventory at a given time for the purposes of creating usable cannabis products. The Administration may query the seed-to-sale tracking system to ensure compliance with this section. A dispensary may not weigh, package, repackage, or create usable cannabis products at the point of sale, or conduct deli-style sales. In this regulation, “novel product” means a cannabis product that is: Not presently authorized in Maryland; and Lawfully produced in another jurisdiction. A licensed processor may submit a request to the Administration in a manner prescribed by the Administration to approve a novel product. A valid novel product request shall include: A detailed product description; An explanation of how the product deviates from current regulations; Evidence that the same product type is permitted in at least one other state’s regulated cannabis market; and Health and safety information, including but not limited to: Available information or studies regarding any beneficial or adverse effects from the use of the product; and Packaging and labeling strategies to minimize risk to patients, consumers, and children. The Administration may: Make its own determination to approve or deny the request; or Defer the request to the Public Health Advisory Council. The Administration reserves the right to make a final determination on the request Alcoholic Beverages and Cannabis Article, §§36-202, 36-203, and 36-203.1, Annotated Code of Maryland Effective date: Regulations .01—.11 adopted as an emergency provision effective July 1, 2023 (50:14 Md. R. 559); emergency status expired June 30, 2024 Regulations .01—.11 adopted as an emergency provision effective June 7, 2024 (51:14 Md. R. 676) Regulations .01—.11 adopted effective July 22, 2024 (51:14 Md. R. 678) Regulation .05G amended effective March 16, 2026 (53:5 Md. R. 244) Regulation .08C amended effective April 14, 2025 (52:7 Md. R. 324) Regulation .12 adopted effective April 14, 2025 (52:7 Md. R. 324)