Minn. R. agency 144, ch. 4770, pt. 4770.0400

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

Part 4770.0400 - MEDICAL CANNABIS MANUFACTURER; OPERATIONS

Subpart 1.Operating documents.

Under Minnesota Statutes, section 152.29, subdivision 1, the operating documents of a medical cannabis manufacturer must describe operational and management practices, including:

A. record keeping;

B. security measures to deter and prevent theft of medical cannabis;

C. unauthorized entrance into areas containing medical cannabis;

D. types and quantities of medical cannabis products that are produced at the manufacturing facility;

E. methods of planting, harvesting, drying, and storage of medical cannabis;

F. estimated quantity of all crop inputs used in production;

G. estimated quantity of waste material to be generated;

H. disposal methods for all waste materials;

I. employee training methods for the specific phases of production;

J. biosecurity measures used in production and in manufacturing;

K. strategies for reconciling discrepancies in plant material or medical cannabis;

L. sampling strategy and quality testing for labeling purposes;

M. medical cannabis packaging and labeling procedures;

N. procedures for the mandatory and voluntary recall of medical cannabis;

O. plans for responding to a security breach at a manufacturing or distribution facility, or while medical cannabis is in transit to a manufacturing or distribution facility;

P. business continuity plan;

Q. records relating to all transport activities; and

R. other information requested by the commissioner.

Subp. 2. Prohibited activities.

A. A person may not own and operate a manufacturing facility unless the person is registered as a medical cannabis manufacturer by the commissioner under Minnesota Statutes, section 152.25.

B. A medical cannabis manufacturer and its employees, agents, or owners may not:

(1) cultivate, produce, or manufacture medical cannabis in any location except in those areas designated for those activities in the registration agreement;

(2) sell or distribute medical cannabis or medical cannabis products from any location except its distribution facilities;

(3) produce or manufacture medical cannabis for use outside of Minnesota;

(4) sell or distribute medical cannabis to any person other than a registered:

(a) patient;

(b) parent or legal guardian; or

(c) designated registered caregiver;

(5) deliver or transport medical cannabis to any location except the manufacturer's production facility or distribution facilities, a waste-to-energy facility, another manufacturer's distribution facilities, a testing laboratory approved by the commissioner, and a laboratory selected by the commissioner to conduct audit testing under part 4770.3035;

(6) sell medical cannabis that is not packaged and labeled in accordance with part 4770.0850; or

(7) permit the consumption of medical cannabis at a distribution facility.

Subp. 3.Criminal background checks.

A medical cannabis manufacturer is prohibited from employing any person who has a disqualifying felony offense as shown by a Minnesota criminal history background check or a federal criminal history background check performed by the Bureau of Criminal Apprehension under Minnesota Statutes, section 152.29, subdivision 1.

Subp. 4.Conflict of interest; health care practitioner activity restrictions.

A medical cannabis manufacturer may not:

A. permit a health care practitioner who certifies qualifying conditions for patients to:

(1) hold a direct or indirect economic interest in the medical cannabis manufacturer;

(2) serve on the board of directors or as an employee of the medical cannabis manufacturer; or

(3) advertise with the medical cannabis manufacturer in any capacity;

B. accept or solicit any form of remuneration from a health care practitioner who certifies qualifying conditions for patients; or

C. offer any form of remuneration from a health care practitioner who certifies qualifying conditions for patients.

Minn. R. agency 144, ch. 4770, pt. 4770.0400

46 SR 1011