Minnesota Administrative Rules

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 logo.

Subp. 2.

Medical cannabis trade names.

The medical cannabis manufacturer's medical cannabis trade 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; and

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.

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.

Statutory Authority:

MS s 14.389; 152.25; 152.26

History:

39 SR 1080

Published Electronically:

February 20, 2015