N.M. Admin. Code § 7.34.4.14

Current through Register Vol. 35, No. 21, November 5, 2024

Section 7.34.4.14 - DEPARTMENT APPROVAL OF MANUFACTURERS OF CANNABIS DERIVED PRODUCTS; GENERAL MANUFACTURING PROVISIONS

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.

N.M. Admin. Code § 7.34.4.14

7.34.4.14 NMAC - Rp, 7.34.4.12 NMAC, 12/30/2010, Amended by New Mexico Register, Volume XXVI, Issue 04, February 27, 2015, eff. 2/27/2015, Amended by New Mexico Register, Volume XXVII, Issue 04, February 29, 2016, eff. 2/29/2016, Amended by New Mexico Register, Volume XXX, Issue 20, October 29, 2019, eff. 10/4/2019, Adopted by New Mexico Register, Volume XXXI, Issue 12, June 23, 2020, eff. 6/23/2020