New Mexico Administrative Code › Title 7 - HEALTH › Chapter 34 - MEDICAL USE OF CANNABIS › Part 4 - LICENSING REQUIREMENTS FOR PRODUCERS, PRODUCTION FACILITIES AND DISTRIBUTION › Section 7.34.4.14 - DEPARTMENT APPROVAL OF MANUFACTURERS OF CANNABIS DERIVED PRODUCTS; GENERAL MANUFACTURING PROVISIONS

Current through Register Vol. 35, No. 13, July 16, 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.