Minnesota Administrative Rules

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)

produce or manufacture medical cannabis in any location except in those areas designated in the registration agreement;

(2)

sell, deliver, transport, or distribute medical cannabis or medical cannabis products from any location except its manufacturing facility or its distribution facility;

(3)

produce or manufacture medical cannabis for use outside of Minnesota;

(4)

sell or distribute medical cannabis to any person other than a:

(a)

patient;

(b)

parent or legal guardian; or

(c)

designated registered caregiver;

(5)

deliver or transport medical cannabis to any location except its distribution facilities and a laboratory approved by the commissioner;

(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.

Statutory Authority:

MS s 14.389; 152.25; 152.26

History:

39 SR 1080

Published Electronically:

February 20, 2015