15.03.220 Brand Cannabinoid Contents

(a) A registered entity shall only produce such forms of medical marijuana as approved by the Authority according to the following requirements:

(1) Each registered entity may initially produce up to five brands of medical marijuana product with prior approval of the Authority. These brands may be produced in multiple forms as approved by the Authority. Thereafter, additional brands may be approved by the Authority.

(2) Each medical marijuana product brand, in its final form, shall be defined as having a specific concentration of total Tetrahydrocannabinol (THC) and total Cannabidiol (CBD) and shall have a consistent cannabinoid profile. The concentration of the following cannabinoids, at a minimum, must be reported:

(A) Tetrahydrocannabinol (THC)

(B) Tetrahydrocannabinol acid (THCA)

(D) Cannabidiol (CBD)

(E) Cannabinadiolic acid (CBDA)

(F) Cannabidivarine (CBDV)

(G) Cannabinol (CBN)

(H) Cannabigerol (CBG)

(I) Cannabichromene (CBC)

(J) Any other cannabinoid component at > 0.2 percent, for which there is a certified standard available at a customary cost.

(3) The final medical marijuana product shall not contain less than 90 percent or more than 110 percent of the concentration of total THC or total CBD indicated on the label for this brand and shall have no more than 10mg total THC per dose. However:

(4) Where the total THC concentration is less than 5 milligrams per dose, the concentration of total THC shall be within 0.5 milligrams per dose;

(5) Where the total CBD concentration is less than 5 milligrams per dose, the concentration of total CBD shall be within 0.5 milligrams per dose; and

(6) the concentration of total THC and CBD in milligrams per single dose for each sample of a brand lot submitted for testing must be within 25 percent of the mean concentration of total THC and CBD in milligrams per single dose for that submitted lot with the exception that, for brands with a specified total THC and CBD concentration less than 2 milligrams per single dose, the concentration of each sample for that low concentration cannabinoid shall be within 0.5 milligrams per dose of the mean concentration.

(7) The registered entity shall offer and make available to patients at least one brand that has a low THC and a high CBD content (e.g., a 1:20 ratio of THC to CBD).

(8) The registered entity shall offer and make available at least one brand that has approximately equal amounts of THC and CBD.

(9) For each brand offered, the registered entity shall only utilize a distinct name which has been approved by the Authority, consisting of only letters and/or numbers. The name shall not be coined or fanciful, and may not include any "street", slang or other name. No reference shall be made to any specific medical condition.

(10) Each registered entity shall ensure the availability of at least a one-year supply of any offered brand unless otherwise allowed by the Authority.

(b) The registered entity shall not add any additional active ingredients or materials to any approved medical marijuana product that alters the color, appearance, smell, taste, effect or weight of the product unless it has first obtained prior written approval of the Authority. Excipients must be pharmaceutical grade and approved by the Authority.