18- 691 C.M.R. ch. 4, § 8

Current through 2024-36, September 4, 2024

Section 691-4-8 - Packaging, Labeling and Marketing Manufactured Marijuana

Packaging and labeling for all transfers, including wholesale, must specify content and declare the quantity of contents in terms of weight, measure or count; list the registry identification card number and registry identification number of the source, if applicable; date of transfer; the identifier(s) required for the Department's monitoring system, if any; and results of any required testing conducted by a licensed marijuana testing facility, if any. Marijuana for medical use on the premises, whether in process, stored or displayed, must be secure, measured and distinguishable from other products. Packaging and labeling must be in accordance with 22 MRS §§2423-F and 2430-G.

8.1 - Packaging Requirements A registered caregiver, dispensary or manufacturing facility must package all marijuana products and marijuana concentrates prior to transfer to a qualifying patient. The packaging must:

A. Be tamper-evident and maintain an unbroken seal;

B. Completely enclose the entirety of marijuana product or concentrate;

C. Contain labeling on an easily identifiable portion of the packaging as specified in Section 8.2 of this rule; and

D. Conform to packaging and labeling requirements under applicable licenses held by the manufacturing facility, including required food establishment licenses, if any.

However, nothing in these rules shall be construed to prohibit the packaging of marijuana products or concentrates in reusable packaging provided to the registered caregiver, dispensary, or manufacturing facility by a qualifying patient for the packaging of marijuana products or marijuana concentrates for use by that same qualifying patient, so long as such packaging conforms with the requirements above.

8.2 - Labeling Requirements

A. All manufactured marijuana products and marijuana concentrates must be labeled and include the following information:

(1) The registry identification number of the manufacturing facility;

(2) Ingredients other than marijuana contained in the marijuana product or marijuana concentration;

(3) Any pesticides, chemicals, solvents or other substances used to manufacture the marijuana product or concentrate;

(4) A unique identifier to trace the marijuana used to manufacture the marijuana product or marijuana concentrate. This could be a batch number, track and trace identifier or other means required by the Department.

(5) Results from the certificate of analysis for testing required by the Department and performed by a valid licensed marijuana testing facility, if any:

(a) If the marijuana product or concentrate has undergone testing by a valid marijuana testing facility, the product or concentrate must bear a label displaying the THC and CBD content of the cannabinoid profile; a yes-or-no indication that the product has passed testing for pesticides, residual solvents and other contaminants; and a link to the online results of the full certificate of analytical results;

(b) If the marijuana product or concentrate has not been tested by a licensed marijuana testing facility, and no such test is required, the product or concentrate must display a label with the following disclosure "THIS PRODUCT HAS NOT UNDERGONE TESTING FOR CONTAMINANTS, PESTICIDES, RESIDUAL SOLVENTS OR OTHER CONTAMINANTS BY A LICENSED MARIJUANA TESTING FACILITY.

THIS PRODUCT MAY CONTAIN HARMFUL MATERIAL AND COULD BE HAZARDOUS TO YOUR HEALTH.";

(6) A warning indicating that medical marijuana is present, that the marijuana product is not FDA approved, and, the Department's universal symbol indicating the presence of marijuana; and

(7) A warning that marijuana product or concentrate should be kept away from minors and that caution must be exercised before driving or using heavy machinery.

B. No marijuana product or concentrate label from a registered manufacturing facility may include information about the THC or CBD contents or the profile of the product, or values of any test required by the Department unless the values are based on a homogenized sample tested by an accredited marijuana testing facility, and, if the Department has licensed a marijuana testing facility, values must be reported as provided in the certificate of analysis from a licensed marijuana testing facility, if any.

8.3 - Education Materials A manufacturing facility must have available for the recipient of the manufactured marijuana educational materials related to the marijuana product or concentrate and any solvents used by the facility. The educational materials must include the following, as applicable:

A. Identification of the source of each informational material;

B. Information about methods of administration, the marijuana product or concentrate and how it should be correctly used;

C. Information on the risks of using marijuana, including prior to driving or operating heavy machinery, during pregnancy or while breast feeding;

D. Information about the manufacturing process used to manufacture the marijuana product or concentrate, including any solvents used; and

E. A recommended dosage guide for edible or tincture products and a warning that effects may take up to two hours to experience. Each 10mg of THC will be considered a dose for purposes of the guide.

18- 691 C.M.R. ch. 4, § 8