Current through Register Vol. 35, No. 6, March 26, 2024
An applicant for initial or renewal non-profit producer
licensure shall provide materials and information to the department, in
accordance with the provisions of this section, in order to be considered for a
license to produce medical cannabis. A licensed non-profit producer shall also
promptly submit revised versions of any such materials in the event that the
materials or their content change.
A.
Organizational information and materials: An applicant for
non-profit producer licensure shall submit to the department:
(1) proof that the private entity is a
non-profit corporation in good standing with the NM secretary of state pursuant
to Section
53-8-1
et seq., NMSA 1978;
(2) proof that the non-profit producer is in
good standing with the New Mexico taxation and revenue department;
(3) copies of the entity's articles of
incorporation;
(4) copies of the
entity's by-laws;
(5) verification
that the board of directors of the non-profit includes, at a minimum, five
voting members, including one medical provider limited to a physician (MD or
OD), a registered nurse, nurse practitioner, licensed practical nurse, or
physician assistant, and three patients currently qualified under department
regulations and the Lynn and Erin Compassionate Use Act, Section
26-2B-1
et seq., NMSA 1978;
(6) a list of all persons or business
entities having direct or indirect authority over the management or policies of
the private entity;
(7) a list of
all persons or business entities having any ownership interest in any property
utilized by the non-profit producer, whether direct or indirect, and whether
the interest is in land, building(s), or other material, including owners of
any business entity that owns all or part of land or building(s)
utilized;
(8) the identities and
financial information, including information concerning loans and monetary
investments, of all creditors currently holding a security interest in the
non-profit producer or premises of the non-profit producer, if any;
and
(9) a business plan showing how
the private entity intends to fund its operations and become a successful
producer, including information concerning personnel, horticulture, technology,
and funding sources.
B.
Production and distribution information and materials: An
applicant for non-profit producer licensure shall submit to the department:
(1) an acknowledgement that production, at
any time, shall not exceed the total of cannabis plants that the non-profit
entity has been approved to produce as well as an inventory of usable cannabis
that reflects current patient needs;
(2) a production plan that includes the
non-profit entity's plan for the growth, cultivation, and harvesting of medical
cannabis;
(3) a written set of
distribution criteria for qualified patients or primary caregivers appropriate
for cannabis services that describes the method by which and locations at which
distribution will occur;
(4) a
complete written description of the means that the non-profit entity shall
employ to safely dispense cannabis and cannabis-derived products to qualified
patients and qualified patients' primary caregivers;
(5) an attestation that qualified patients
shall not be permitted to consume cannabis or cannabis-derived products on the
entity's property, unless the consumption occurs in a department approved
cannabis consumption area;
(6) an
attestation that the entity will require the presentation of a
department-issued identification card and a valid New Mexico photo
identification card or a passport prior to selling or otherwise distributing
cannabis or cannabis derived products to qualified patients and primary
caregivers;
(7) a description and
sample of the packaging of the usable cannabis and cannabis-derived products
that the non-profit producer shall utilize, including a label that satisfies
the labeling requirements of this rule; and
(8) a written quality assurance
plan.
C.
Facility
information: An applicant for non-profit producer licensure shall submit
to the department:
(1) a description of the
facilities and equipment that shall be used in the production distribution of
cannabis, and manufacture of cannabis-derived products (as
applicable);
(2) proof that the
facilities are not within 300 feet of any school, church, or daycare center; or
alternatively, proof that any school, church, or daycare center that is located
within 300 feet of a building to be used by the applicant did not occupy that
location prior to the applicant initially seeking to become licensed to operate
at the location; and
(3) a
description of the methods and device or series of devices that shall be used
to provide security.
D.
Educational methods and materials: An applicant for non-profit
producer licensure shall submit to the department:
(1) a description of the private entity's
means for educating the qualified patient and the primary caregiver on the
limitation of the right to possess and use cannabis;
(2) a description of the means the private
entity shall employ to make qualified patients or the primary caregiver aware
of the quality of the product;
(3)
a description of ingestion options of usable cannabis provided by the private
entity;
(4) a description of
inhalation techniques that shall be provided to qualified patients;
(5) a description of potential side effects
and how the private entity will educate qualified patients and the qualified
patient's primary caregivers regarding potential side effects;
(6) a description of the means the private
entity shall employ to make qualified patients or the primary caregiver aware
of how to report adverse events related to medical cannabis use; and
(7) a description of the means the private
entity shall employ to make qualified patients or the primary caregiver aware
of how to report concerns regarding the private entity's products and
services.
E.
Sales record forms: A licensed non-profit producer that applies for
renewal of licensure shall submit to the department a sample of the non-profit
producer's sales record form(s), which shall identify (among other items) the
name of the purchaser, the date of the sale, the quantity, and price of medical
cannabis sold. A non-profit producer that applies for renewal of licensure
shall additionally submit a profit and loss statement and balance sheet
quarterly and as requested by the department.
F.
Business licensure; TRD
certificate: An applicant for non-profit producer licensure shall submit
a current business license and tax and revenue registration
certificate.
G.
Policies and
procedures: An applicant for non-profit producer licensure shall submit
to the department copies of policies and procedures developed, implemented, and
to be maintained on the premises of the private entity's facility. The
applicant shall verify that the private entity will comply with the stated
terms of the policies and procedures as written and submitted to the
department.
H.
Personnel
records: An applicant for non-profit producer licensure shall submit to
the department:
(1) separate nationwide and
statewide criminal history screening documentation, in accordance with the
provisions of this rule;
(2)
samples of the personnel records to be retained by the private entity for each
employee as required by this rule, including:
(a) a sample application for
employment;
(b) state and federal
employment documentation;
(c) a
sample written job descriptions or employment contracts developed for all
employee positions, to include duties, authority, responsibilities,
qualifications, and supervision;
(d) payment or payroll records for all
individuals associated with a non-profit producer renewal applicant's
production and distribution facility, to include board members, persons having
direct or indirect authority over management or policies, and employees
submitted quarterly and as requested by the department.
(3) an on-site training curriculum (unless
the private entity intends to enter into contractual relationships with outside
resources capable of meeting employee training needs) that addresses, at a
minimum, the following topics:
(a) state and
federal confidentiality laws, including the Health Insurance Portability and
Accountability Act of 1996 (HIPAA);
(b) professional conduct and
ethics;
(c) the Lynn and Erin
Compassionate Use Act and department of health rules;
(d) informational developments in the field
of medical use of cannabis;
(e)
employee safety and security training addressing, at a minimum, the proper use
of the security measures and controls that have been adopted, and specific
procedural instructions on how to respond to an emergency, including a robbery
or violent accident;
(f) robbery
awareness and conflict de-escalation training for all employees;
(g) general food safety training.
(4) proof of HIPAA certification
for all individuals associated with the private entity, including all board
members, persons having direct or indirect authority over management or
policies, and employees.
I.
Other materials: An applicant
for non-profit producer licensure shall submit to the department:
(1) a description of the department approved
laboratory or laboratories that the non-profit entity will utilize for testing
usable cannabis in accordance with this rule, and the type(s) of testing that
the approved laboratory or laboratories will perform for the non-profit
entity;
(2) the name of any courier
that the non-profit entity intends to use for transport of usable cannabis to
qualified patients and primary caregivers; and
(3) such other information as the private
entity wishes to provide and such other information as the department may
reasonably request.
J.
Patient identification and sales records: A licensed non-profit
producer shall retain clear, legible photocopies or electronic copies of
current registry identification cards and current New Mexico photo
identification cards of all qualified patients and primary caregivers served by
the non-profit entity. A licensed non-profit producer shall also create and
retain materials that document every instance in which usable cannabis was sold
or otherwise distributed to another person or entity, including documentation
of the recipient, type, quantity, and batch of the usable cannabis.
K.
Material safety data sheets:
A licensed non-profit producer shall maintain current material safety data
sheets on-site for all chemicals used, including but not limited to cleaning
compounds, sanitizing agents, and pesticides.
L.
State and local laws: A
licensed non-profit producer shall comply with all applicable state and local
laws regarding construction, occupancy, and operation of a facility or
building, including but not limited to zoning, occupancy, licensing, and
building codes.
