Minn. R. agency 144, ch. 4770, pt. 4770.0850

Current through Register Vol. 49, No. 19, November 4, 2024

Part 4770.0850 - PACKAGING AND LABELING

Subpart 1.Medical cannabis packaging.

The medical cannabis manufacturer must package all medical cannabis intended for distribution according to the following standards:

A. In addition to the requirements in Minnesota Statutes, section 152.29, subdivision 3, paragraph (c), clause (5), medical cannabis containers must be:

(1) plain;

(2) designed to maximize the shelf life of contained medical cannabis;

(3) tamper-evident; and

(4) child-resistant.

B. Medical cannabis packaging must not bear a reasonable resemblance to any commercially available product.

C. Medical cannabis packaging must be packaged to minimize its appeal to children and must not depict images other than the medical cannabis manufacturer's business name or logo.

Subp. 2. Medical cannabis brand names.

The medical cannabis manufacturer's medical cannabis brand names must comply with the following standards and are subject to approval by the commissioner:

A. names that are limited to those that clearly reflect the product's medical cannabis nature;

B. any name that is identical to, or confusingly similar to, the name of an existing noncannabis product is prohibited;

C. any name that is identical to, or confusingly similar to, the name of an unlawful product or substance is prohibited;

D. any name that contains language that suggests using medical cannabis for recreational purposes or for a condition other than a qualifying medical condition is prohibited;

E. any name that is likely to be attractive to children; and

F. a brand name for dried raw cannabis may include the use of strain names. Brand names that include strain names that are likely to appeal to children may only be published or advertised on the manufacturer's website and in its distribution facilities.

Subp. 3.Labeling.

A. A medical cannabis manufacturer must ensure that all medical cannabis that is distributed is labeled with the following information:

(1) the patient's registry identification number, name, and date of birth;

(2) the name and date of birth of the designated registered caregiver, if applicable;

(3) the name of the patient's parent or legal guardian, if listed on the registry verification, if applicable;

(4) the patient's address;

(5) the name and address of the medical cannabis manufacturer where the medical cannabis was manufactured;

(6) the medical cannabis's chemical composition;

(7) the recommended dosage;

(8) directions for use of the product;

(9) all ingredients of the product shown with common or usual names, including any colors, artificial flavors, and preservatives, listed in descending order by predominance of weight;

(10) the date of manufacture and batch number;

(11) a notice with the statement, including capitalization: "This product has not been analyzed or approved by the United States Food and Drug Administration. There is limited information on the side effects of using this product, and there may be associated health risks. Do not drive or operate heavy machinery when under the influence of this product. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN."; and

(12) a notice with the statement: "This medical cannabis is for therapeutic use only. Diversion of this product is unlawful and may result in the revocation of the patient's registration."

B. Labeling text must not include any false or misleading statements regarding health or physical benefits to the patient.

C. A package may contain multiple labels if the information required by this part is not obstructed.

Subp. 4.Supplemental label information.

A. A manufacturer must include a supplemental label that contains information about each pesticide, including the manufacturer's name and brand name of the pesticide, that was applied to the cannabis plant or growth medium prior to or after harvest.

B. A manufacturer may include additional information, including:

(1) cannabis strain name(s) of the finished good;

(2) the results of terpene profile testing under part 4770.3032 and the date of testing;

(3) testing laboratory certificates of analysis for safety and potency;

(4) a warning to avoid operating a motor vehicle if impaired by medical cannabis;

(5) labeling information translated into another language; and

(6) other information approved by the commissioner.

C. The manufacturer may also provide the additional information required or permitted by this subpart on a product-specific page on the manufacturer's website, or through written material made available in its distribution facilities.

Minn. R. agency 144, ch. 4770, pt. 4770.0850

46 SR 1011