Minnesota Administrative Rules
Agency 144 - Health Department
Chapter 4770 - MEDICAL CANNABIS
Part 4770.0850 - PACKAGING AND LABELING
Universal Citation: MN Rules 4770.0850
Current through Register Vol. 49, No. 13, September 23, 2024
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.
Disclaimer: These regulations may not be the most recent version. Minnesota may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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