NDAC 33-44-01-11
Operations manual
Cite as N.D. Admin. Code ยง 33-44-01-11
1.
A compassion center operations manual must include:
a.
Procedures for the oversight of the compassion center, including documentation of the
reporting and management structure of the compassion center. The procedures must
include a business continuity plan.
b.
Procedures to ensure accurate recordkeeping.
c.
Employee security policies, including information related to the unauthorized entrance
into restricted access areas.
d.
Personal safety and crime prevention techniques.
e.
Safety and security procedures, including a disaster plan with procedures to be followed
in case of fire, security breach, or other emergency. Security breach procedures must
include an event occurring during the transportation of marijuana, usable marijuana, and
marijuana waste.
f.
An overview of the inventory control provisions consistent with North Dakota Century
Code section 19-24.1-26 and these rules.
g.
A job description or employment contract developed for all employees and volunteers
which includes duties, responsibilities, authority, qualification, and supervision.
h.
An alcohol-free and drug-free workplace policy.
i.
A description of the usable marijuana containers the compassion center utilizes in
accordance with North Dakota Century Code section 19-24.1-21 and these rules.
j.
A description of the documentation required to accompany a registered compassion
center agent while transporting marijuana, usable marijuana, and medical marijuana
waste on behalf of the compassion center. Documentation must be in accordance with
these rules.
k.
Procedures for the mandatory, or voluntary, recall of usable marijuana in accordance with
these rules.
l.
Any other information requested by the department.
2.
A manufacturing facility's operations manual must also include:
a.
Detailed procedures regarding the producing, processing, and testing of marijuana and
usable marijuana. The procedures must include a description of how marijuana will be
sampled and tested in accordance with these rules.
b.
Procedures for ensuring compliance with quality control and quality assurance
requirements in accordance with these rules.
c.
Procedures for ensuring manufacturing areas are maintained in a clean and orderly
condition.
d.
Procedures for addressing infestation by insects, rodents, birds, or vermin of any kind.
e.
A description of the types of usable marijuana produced and processed by the
manufacturing facility.
3.
A dispensary's operations manual also must include:
a.
Procedures for safely dispensing usable marijuana to registered qualifying patients and
registered designated caregivers.
b.
A distribution plan to provide registered qualifying patients and registered designated
caregivers access to usable marijuana.
c.
A description of the dispensary's outreach activities for registered qualifying patients and
registered designated caregivers which must include:
(1)
Offering each new registered qualifying patient who visits the dispensary with a
department-issued document that explains the state and federal law limitations of
usable marijuana;
(2)
Offering information regarding the forms of usable marijuana available at the
dispensary;
(3)
Offering information regarding potential side effects of marijuana use; and
(4)
A plan regarding the implementation of outreach activities.
4.
A compassion center shall maintain and follow its operations manual at all times. A
compassion center shall provide the department with written notice of any updates or
revisions to the operations manual within thirty days of the changes.