Current through Register Vol. 49, No. 13, September 23, 2024
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.