Md. Code Regs. 14.17.13.05

Current through Register Vol. 51, No. 24, December 2, 2024

Section 14.17.13.05 - Edible Cannabis Products

A. General Requirements.

(1) 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.

(2) 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.

(3) 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;

(b) The varying levels of potency and dosing of the edible cannabis product;

(c) The recipe, including the production process, for manufacturing the edible cannabis product; and

(d) Any scientific studies or laboratory testing results supporting the stability and approximate expiration date of the edible cannabis product.

(4) 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:

(a) Product complies with the requirements of this chapter; and

(b) Safety of minors.

B. Dosage Requirements.

(1) Unless expressly authorized by the Administration, an edible cannabis product may not contain more than:

(a) 10 milligrams of THC per serving; and

(b) 100 milligrams of THC per package.

(2) 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.

(3) 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.

(4) 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) A permittee submits a request in a form prescribed by the Administration; and

(b) The request complies with §G of this regulation.

(5) An edible cannabis product consisting of multiple servings shall be homogenized so that each serving contains the same concentration of THC.

C. Appearance of Edible Cannabis Products.

(1) A permittee shall only manufacture or distribute solid edible cannabis product in geometric shapes.

(2) A permittee may not manufacture an edible cannabis product that due to its shape, design, or flavor is likely to appeal to minors.

(3) The manufacture or sale of edibles in the following shapes is prohibited:

(a) Human, animal, toy, or fruit;

(b) 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

(c) A commercially available food or beverage product that targets or is primarily marketed to minors.

D. Liquid Edible Product Requirements.

(1) A liquid edible product container may not contain more than a single serving per container.

(2) A single serving of a liquid edible product may not exceed 10 milligrams of THC per container.

(3) A liquid edible product shall otherwise comply with this regulation.

E. Prohibited Products.

(1) Edible cannabis products may not contain:

(a) Meat;

(b) Seafood;

(c) Unpasteurized eggs; or

(d) Unpasteurized dairy of any type.

(2) The following types of products may not be sold:

(a) Alcoholic beverages, as defined in Alcoholic Beverage and Cannabis Article, §1-101, Annotated Code of Maryland; and

(b) 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.

(3) The prohibition in §E(2)(b) of this regulation does not apply to products containing naturally occurring caffeine, such as coffee, tea, or chocolate.

F. 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:

(1) 21 CFR, as amended;

(2)21 U.S.C. § 343, as amended;

(3)21 U.S.C. §§ 451-471, as amended; and

(4)21 U.S.C. §§ 601-695, as amended.

G. High Potency Edible Cannabis Products.

(1) 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.

(2) A permittee shall submit to the Administration a third-party certification that demonstrates compliance with §G(1) of this regulation.

(3) Demonstration of compliance required under §G(2) of this regulation shall include:

(a) 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;

(b) 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;

(c) 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

(d) Documentation that the dosage form is recognized by the United States Pharmacopeia, the National Formulary, or the Food and Drug Administration.

(4) Edible products produced with approval by the Administration under §B(4) of this regulation may not:

(a) Be a liquid edible product as described in §D of this regulation; or

(b) Contain more than:

(i) 40 milligrams of THC per serving; and

(ii) 400 milligrams of THC per package.

(5) A dispensary shall only sell or dispense high potency edible products to qualified patients and registered caregivers.

(6) A processor shall label high potency edible products in accordance with COMAR 14.17.18.04.

H. The Administration shall maintain permittee trade secrets in conformity with COMAR 14.17.11.05.

Md. Code Regs. 14.17.13.05

Regulation .05 adopted effective 50:14 Md. R. 559, eff. 7/1/2023 (EMERGENCY); adopted effective 51:14 Md. R. 676, eff. 6/7/2024, exp. 8/31/2024 (Emergency); adopted effective 51:14 Md. R. 678, eff. 7/22/2024.