Current through Register Vol. 35, No. 18, September 24, 2024
A.
Submittal of applications: A manufacturer applicant shall submit
an authorized application form to the program with each initial application and
renewal application, together with a fee of five thousand dollars ($5,000)
issued to the medical cannabis program. A manufacturer applicant shall comply
with the application requirements of this rule, and shall submit such other
information as the manufacturer applicant wishes to provide or such information
as the department may request for initial approval or periodic evaluation(s)
during the approval period.
B.
Application requirements: A manufacturer applicant shall submit to
the department:
(1) proof that the
manufacturer applicant is in good standing with the New Mexico taxation and
revenue department;
(2) copies of
the manufacturer applicant's articles of incorporation and by-laws, as
applicable;
(3) a complete written
description of the means that the manufacturer applicant shall employ to safely
manufacture cannabis-derived products, including but not limited to hygiene
standards consistent with the requirements of this rule, and a hazard analysis
critical control point plan (HACCP) for each type of product that the
manufacturer wishes to manufacture;
(4) a detailed list of all cannabis derived
products to be manufactured;
(5) a
list of all persons or business entities having direct or indirect authority
over the management or policies of the manufacturer applicant;
(6) a list of all persons or business
entities having any ownership interest in any property utilized by the
manufacturer applicant, 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;
(7) a description of the facilities that
shall be used in the manufacture of cannabis derived products;
(8) proof that no buildings to be used by the
manufacturer are located 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;
(9) a description of how the manufacturer
applicant will obtain cannabis or cannabis concentrates from a licensed
non-profit producer, and how the manufacturer applicant will transport cannabis
derived products to a licensed non-profit producer, including but not limited
to chain of custody documentation;
(10) testing criteria and procedures, which
shall be consistent with the testing requirements of this rule;
(11) a general written security policy, to
address at a minimum:
(a) safety and security
procedures;
(b) personal
safety;
(c) crime prevention
techniques.
(12) an
attestation that no firearms will be permitted on any premises used for
manufacture of cannabis derived products by the manufacturer
applicant;
(13) a description of
the methods and device or series of devices that shall be used to provide
security, as well as documentation of successful testing of alarms and law
enforcement notification system;
(14) training documentation prepared for each
employee of the manufacturer applicant, statements signed by employees
indicating the topics discussed (to include names and titles of presenters) and
the date, time, and place the employee received said training;
(15) employee policies and procedures to
address the following requirements:
(a) job
descriptions or employment contracts developed for every employee of the
manufacturer applicant that identify duties, authority, responsibilities,
qualifications, and supervision; and
(b) training materials concerning adherence
to state and federal confidentiality laws.
(16) personnel records for each employee of
the manufacturer applicant that include an application for employment and a
record of any disciplinary action taken;
(17) employee safety and security training
materials provided to each employee of the manufacturer applicant at the time
of his or her initial appointment, to include:
(a) training in the proper use of security
measures and controls that have been adopted; and
(b) specific procedural instructions
regarding how to respond to an emergency, including robbery or a violent
accident;
(18) an
attestation that the manufacturer applicant will ensure that all persons who
work at a facility of the manufacturer will be 18 years of age or
older;
(19) a description of how
the manufacturer applicant will utilize the electronic inventory tracking
system required by the department;
(20) a written policy to ensure that no
cross-contamination of cannabis occurs;
(21) copies of any applicable lease
agreements for facilities to be used by the manufacturer applicant;
(22) an attestation that the manufacturer
applicant has complied and will comply with all applicable state and local
zoning, occupancy, licensing and building codes applicable to buildings to be
utilized by the manufacturer;
(23)
proof of prior approval by the New Mexico regulation and licensing department
for the use of any compressed gas extraction equipment to be utilized by the
manufacturer;
(24) an attestation
that the manufacturer applicant will not use dimethylsulfoxide (DMSO) in the
production of cannabis derived products, and will not possess DMSO on the
premises of the manufacturer;
(25)
a written statement of the days and hours that the manufacturer will
operate;
(26) such other materials
as the department may require.
C.
Prohibited additives: A
manufacturer and a non-profit producer shall not manufacture or distribute a
product that is intended to be consumed by inhalation that includes
polyethylene glycol, polypropylene glycol, vitamin E acetate, or medium chain
triglycerides. A manufacturer and a non-profit producer shall not combine
nicotine, caffeine, or any other addictive substance with a usable cannabis
product. This prohibition shall not apply to the combination of cannabis with
sugar, or a product in which caffeine is naturally occurring, such as coffee,
tea, or chocolate.
D.
Term of
approval: Department approval of a manufacturer shall be for a term of
one year, and shall expire after that year, or upon closure of the
manufacturer. An approved manufacturer shall apply for renewal of approval
annually no later than 30 days prior to expiration.
E.
Identification cards: An
employee of an approved manufacturer shall carry their department issued
employee identification card at all times during their work, and shall present
the card to law enforcement officials and to department officials upon request.
An employee who is unable to produce their department issued identification
card upon request shall not remain on the licensed premises, and shall produce
the card for the department's inspection prior to returning to the licensed
premises. Identification cards issued by the department are the property of the
department and shall be returned to the department upon termination of the
holder's employment with the approved manufacturer, suspension, or revocation
of approval by the department, or upon demand of the department.
F.
Amended license:
(1) An approved manufacturer shall submit to
the department an application form for an amended license, and shall obtain
approval from the department, at least 30 business days prior to implementing
any:
(a) change of location of the
manufacturer's facilities, change of directors, change of ownership of the
manufacturer's facilities, change of company name, and any physical
modification or addition to the manufacturer's facilities; and
(b) substantial change to the manufacturer's
methods for manufacturing cannabis-derived products, and any substantial change
to the manufacturer's security plan.
(2)
Process for incomplete application
for amended license: In the event that an application for amended
licensure is determined by the program to be incomplete, the program will
specify the information or materials that remain to be submitted. If the
manufacturer does not submit the requested information or material, and does
not otherwise contact the department regarding the application, within thirty
days of receiving notice of the deficiency, the application will be closed as
incomplete, and the manufacturer will be required to resubmit the application
in order to recommence the application process.
G.
Inventory and sales
equipment: The department may require a licensed manufacturer to utilize
specified equipment, software, and services for purposes of tracking inventory,
sales, and other information, and for the purpose of reporting that information
to the department of health.
H.
Reporting of theft to department: A manufacturer shall submit to
the department notification of any theft, robbery, break-in, or security breach
that occurs on the manufacturer's premises, no later than 10 calendar days
after the manufacturer first becomes aware of the event. The description shall
include a description of any property that was stolen or destroyed, and the
quantity of any usable cannabis that was stolen.
I.
Closure of applications
period: The department may close the applications period during which
applications for manufacturer licenses will be accepted and reviewed.
