Section 15. Standards For Manufacture Of Cannabis-Derived Products

The following are minimum requirements for the manufacture of cannabis-derived products which shall apply to all manufacturers and licensed non-profit producers that manufacture cannabis-derived products: A. General requirements: A licensed non-profit producer and a manufacturer shall ensure the following: (1) that all manufacturing shall be done in premises that are in compliance with state and local laws, including but not limited to zoning, occupancy, licensing, and building codes; (2) that the manufacturing operation and all equipment, implements, and fixtures that are used for the manufacture of cannabis derived products shall be used exclusively for the manufacture of cannabis derived products and that food processing for personal, staff, or the general public shall be prohibited; (3) that all manufacturing is done indoors; with the exception that compressed gas extraction may occur outdoors in accordance with applicable standards of the New Mexico regulation and licensing department; (4) that all manufacturing is conducted in a manner that does not allow cross-contamination from chemical or biological hazards; (5) that manufacturing does not occur at a location that is within 300 feet of a school, church, or daycare center that existed within the 300-foot area before the non-profit producer or manufacturer became licensed to operate at the location; (6) that all non-profit producer and manufacturer staff involved in the handling, transportation, manufacture, testing, or packaging of cannabis derived products must complete general food handler safety training; (7) that any person who, by medical examination or supervisory observation, is shown to have, or appears to have, an illness, open lesion, including a boil, sore, or infected wound, or any other abnormal source of microbial contamination for whom there is a reasonable possibility of contact with preparation surfaces for 7.34.4 NMAC 25 medical cannabis or cannabis derived products, shall be excluded from any operations which may be anticipated to resul

rvisory observation, is shown to have, or appears to have, an illness, open lesion, including a boil, sore, or infected wound, or any other abnormal source of microbial contamination for whom there is a reasonable possibility of contact with preparation surfaces for 7.34.4 NMAC 25 medical cannabis or cannabis derived products, shall be excluded from any operations which may be anticipated to result in such contamination until the condition is corrected; (8) that hand-washing facilities are provided that are adequate, accessible, and conveniently located, and that they are furnished with running water at a suitable temperature; hand-washing facilities shall be located in indoor production facilities, in restrooms, and wherever good sanitary practices require employees to wash or sanitize their hands, and shall be stocked with effective hand-cleaning and sanitizing preparations, and sanitary towel service or suitable drying devices; (9) that all persons involved in preparing or handling medical cannabis or cannabis derived products at the manufacturing operation conform to hygienic practices while on duty, including: (a) maintaining adequate personal cleanliness; (b) washing hands thoroughly in an adequate hand-washing area before starting 0work, at any other time when the hands may have become soiled or contaminated, and both before putting gloves on and after removal of gloves; (c) refraining from preparing or handling medical cannabis or cannabis derived products if the handler has or may have an illness, open lesion, including boils, sores, or infected wounds, or any other abnormal source of microbial contamination, until such condition is corrected; (d) complying with the other requirements of this section

and both before putting gloves on and after removal of gloves; (c) refraining from preparing or handling medical cannabis or cannabis derived products if the handler has or may have an illness, open lesion, including boils, sores, or infected wounds, or any other abnormal source of microbial contamination, until such condition is corrected; (d) complying with the other requirements of this section. (10) that there is sufficient space for placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations for production of medical cannabis derived products; (11) that litter and waste are properly removed, and the operating systems for waste disposal are maintained in an adequate manner so that they do not constitute a source of contamination in areas where medical cannabis or cannabis derived products are exposed; (12) that floors, walls, and ceilings are constructed in such a manner that they are washable, wipeable, and non-absorbent, and can be kept clean, and kept in good repair; (13) that walls and ceilings remain free of water damage, and that fiberglass and other insulation material not be exposed; (14) that there is adequate safety-type lighting in all areas where medical cannabis or cannabis derived products are processed or stored, and where equipment or utensils are cleaned; (15) that the manufacturer provides adequate screening or other protection against the entry of pests; rubbish shall be disposed of so as to minimize the development of odor, minimize the potential for the waste becoming an attractant and harborage, or breeding place for pests; (16) that building, fixtures, and other physical facilities where cannabis derived products are manufactured are maintained in a sanitary condition; (17) that all contact surfaces, including utensils and equipment used for preparation of cannabis derived products are cleaned and sanitized as frequently as necessary to protect against contamination; (18) that all equipment and utensils used for preparation of cannabis deri

res, and other physical facilities where cannabis derived products are manufactured are maintained in a sanitary condition; (17) that all contact surfaces, including utensils and equipment used for preparation of cannabis derived products are cleaned and sanitized as frequently as necessary to protect against contamination; (18) that all equipment and utensils used for preparation of cannabis derived products are designed and of such material and workmanship as to be adequately cleanable, and are properly maintained; (19) that only environmental protection agency (EPA) registered sanitizing agents are used in manufacturing operations and that they are used in accordance with labeled instructions; (20) that toxic cleaning compounds, sanitizing agents, and pesticide chemicals shall be identified, held, and stored in a manner that protects against contamination of medical cannabis or cannabis derived products; (21) that any chemicals used for extraction in the manufacturing process be intended for such usage, and that they be of food or medical grade; (22) that the water supply is sufficient for the operations intended and is derived from a source that is a regulated water system; private water supplies shall be from a water source that is capable of providing a safe, potable, and adequate supply of water to meet the manufacturing facility’s needs; (23) that plumbing shall be of adequate size and design, adequately installed, and maintained to carry sufficient quantities of water to required locations throughout the facility; and properly convey sewage and liquid disposable waste from the facility; (24) that there are no cross-connections between the potable and waste water lines; (25) that the manufacturer provide its employees with adequate, readily accessible, on-site toilet facilities that are maintained in a sanitary condition and good repair; (26) that all operations in the receipt, inspection, transport, segregation, preparation, manufacture, packaging, and storage of medical cannabis or cannabis derived prod

oss-connections between the potable and waste water lines; (25) that the manufacturer provide its employees with adequate, readily accessible, on-site toilet facilities that are maintained in a sanitary condition and good repair; (26) that all operations in the receipt, inspection, transport, segregation, preparation, manufacture, packaging, and storage of medical cannabis or cannabis derived products are conducted in accordance with adequate security and sanitation principles; 7.34.4 NMAC 26 (27) that medical cannabis or cannabis derived products that can support the rapid growth of undesirable microorganisms are stored and transported in a manner that prevents the growth of these microorganisms; (28) that storage and transportation of usable cannabis is accomplished under conditions that will maintain security and protect medical cannabis or cannabis derived products against physical, chemical, and microbial contamination as well as against deterioration of the medical cannabis or cannabis derived product and the container; (29) that current material safety data sheets are kept on the premises for all chemicals used, including but not limited to cleaning compounds, sanitizing agents, and pesticides; (30) that extraction for the purpose of manufacturing concentrates is conducted in a closed system utilizing an oil extractor solvent such as N-butane or carbon dioxide or utilizing ethyl alcohol; (31) that all containers used for storage or transport of usable cannabis are washable, wipeable, and nonabsorbent; (32) that if alcohol is to be used for extraction, only food grade, non-denatured ethyl alcohol is used for that purpose; (33) that all weighting or measuring devices that are used in the production, distribution, or manufacture of usable cannabis be appropriately documented as having undergone certified registration and calibration that is in accordance with applicable requirements of the New Mexico department of agriculture; (34) that the manufacture of a cannabis derived product by a manufacturer from the

urpose; (33) that all weighting or measuring devices that are used in the production, distribution, or manufacture of usable cannabis be appropriately documented as having undergone certified registration and calibration that is in accordance with applicable requirements of the New Mexico department of agriculture; (34) that the manufacture of a cannabis derived product by a manufacturer from the cannabis material produced by a personal production license holder is recorded in an electronic tracking system specified by the department; (35) that the manufacturer or non-profit producer will prohibit its employees and contractors from being under the influence of drugs or alcohol in the workplace; (36) that the department is notified of any changes to the days or hours of business operation; (37) that staff who are tasked with conducting compressed gas extraction activities be appropriately trained in the of use of extraction equipment, as well as safety and emergency procedures, by a qualified trainer, prior to beginning extraction activities; (38) that hemp, hemp extract, and hemp derived products (other than hemp paper) are not combined in any manner with usable cannabis that is intended to be sold or otherwise distributed in the medical cannabis program; and (39) that cannabis and cannabis derived products that are kept in manufacturing areas at all times be clearly segregated from hemp and hemp derived products. B. Prohibited products: The use of dimethylsulfoxide (DMSO) in the production of cannabis derived products, and the possession of DMSO upon the premises of a manufacturer or licensed non-profit producer, is prohibited. C

cannabis program; and (39) that cannabis and cannabis derived products that are kept in manufacturing areas at all times be clearly segregated from hemp and hemp derived products. B. Prohibited products: The use of dimethylsulfoxide (DMSO) in the production of cannabis derived products, and the possession of DMSO upon the premises of a manufacturer or licensed non-profit producer, is prohibited. C. Imprinting of certain usable cannabis products with universal THC symbol: A manufacturer and a licensed non-profit producer shall ensure that the universal New Mexico THC warning symbol, or a comparable symbol denoting THC content, is embossed or otherwise imprinted directly upon the following usable cannabis products that contain THC, prior to sale or distribution of any such product to a qualified patient or primary caregiver: (1) chocolate; (2) soft confections; (3) hard confections or lozenges; and (4) pressed pills and capsules [7.34.4.15 NMAC - Rp. 7.34.4.13 NMAC, 6/23/2020] 7.34.4.16 LABELING OF USABLE CANNABIS; DRUG INFORMATION SHEETS: A non-profit producer shall not sell or otherwise distribute to the public a usable cannabis product that has not been packaged and labeled in accordance with this rule. A. Packaging and labels not designed to appeal to children: A package containing usable cannabis shall not display any content that reasonably appears to target minors, including but not limited to, cartoon characters or similar images. A product name or package shall not be modeled after a brand of product that is traditionally marketed toward children. B. Labeling requirements: A label shall be securely affixed to all usable cannabis product packages, prior to sale or distribution, that is in the format provided at Table 8, Sample Label for Usable Cannabis Products, that is conspicuous and unobstructed, and that uses a font that is clearly legible, not italicized, and is 7.34.4 NMAC 27 printed in no smaller than 1/16th of an inch

oward children. B. Labeling requirements: A label shall be securely affixed to all usable cannabis product packages, prior to sale or distribution, that is in the format provided at Table 8, Sample Label for Usable Cannabis Products, that is conspicuous and unobstructed, and that uses a font that is clearly legible, not italicized, and is 7.34.4 NMAC 27 printed in no smaller than 1/16th of an inch. The cannabinoid content specified on a cannabis derived product label shall be ninety percent or greater in accuracy. The label shall identify the following: (1) the names of the entities that produced and manufactured the product, respectively; (2) the name of the strain of cannabis contained in the product; (3) a manufacture date and an expiration date; (4) for dried, usable cannabis: the total of THC and CBD per package, which shall be expressed by percentage of weight; (5) for concentrated cannabis derived product: the total of THC and CBD per package, which shall each be expressed by weight in milligrams and by percentage of total weight; (6) for non-concentrated cannabis derived product: the totals of THC and CBD per package, which shall each be expressed by weight in milligrams; (7) total product weight, expressed in milligrams, and if the product is in liquid form, total volume, expressed in milliliters; (8) the name of the strain; (9) the name of the department approved laboratories that analyzed the product or cannabis contained in the product in accordance with department rule; (10) for all products containing THC: the universal New Mexico THC warning symbol, the image file for which can be obtained from the department upon request, which shall be reproduced at a minimum size of 1/2 inch by 1/2 inch; (11) warnings for use that include at a minimum the statements, “Consumption of THC when pregnant, or by a mother who is breastfeeding, may adversely impact an infant’s development”, “Do not drive a vehicle or operate heavy machinery while under the influence of this product”, and “Keep out of reach of children”

ent upon request, which shall be reproduced at a minimum size of 1/2 inch by 1/2 inch; (11) warnings for use that include at a minimum the statements, “Consumption of THC when pregnant, or by a mother who is breastfeeding, may adversely impact an infant’s development”, “Do not drive a vehicle or operate heavy machinery while under the influence of this product”, and “Keep out of reach of children”; (12) for all cannabis-derived products that contain THC and that are intended to be consumed by vaporization: a health warning that states in bolded text, “WARNING: Vaping THC has been associated with cases of severe lung injury, leading to difficulty breathing, hospitalization, and even death.”; (13) a sales barcode that is associated with the product and product batch; (14) a batch number or code that is associated with the product batch and that is recorded by the non-profit producer or manufacturer in the electronic tracking system specified by the department; and (15) instructions for use that are specific to the labeled product. Table 8. Sample Label for Usable Cannabis Products Producer: Manufacturer: Name of strain: Total units: Net weight: mg Manufacture/Production date: / / Expiration date: / / Laboratory Analysis PER CONTAINER: THC: mg / % THC: % CBD: mg / % CBD: % Testing laboratory: Instructions for use: WARNING: This product contains medical cannabis. Do not drive a vehicle or operate heavy machinery while under the influence of this product. Consumption of THC when pregnant, or by a mother who is breastfeeding, may adversely impact an infant’s development. WARNING: Vaping THC has been associated with cases of severe lung injury, leading to difficulty breathing, hospitalization, and even death. KEEP OUT OF REACH OF CHILDREN. THC NM ! THC NM ! 7.34.4 NMAC 28 C

vehicle or operate heavy machinery while under the influence of this product. Consumption of THC when pregnant, or by a mother who is breastfeeding, may adversely impact an infant’s development. WARNING: Vaping THC has been associated with cases of severe lung injury, leading to difficulty breathing, hospitalization, and even death. KEEP OUT OF REACH OF CHILDREN. THC NM ! THC NM ! 7.34.4 NMAC 28 C. Drug information sheets: A non-profit producer shall generate a drug information sheet for every item of cannabis and cannabis derived product that is sold or distributed to a qualified patient or primary caregiver, and shall provide a copy of the drug information sheet to the qualified patient or primary caregiver at the time of sale or distribution, and upon request. A copy of a drug information sheet shall be provided to the department or its designee upon request. A drug information sheet shall be in the format provided at Table 9, Sample Label for Usable Cannabis Products, and shall use a font that is clearly legible, not italicized, and is printed in no smaller than 10 point type. The drug information sheet shall contain, at a minimum, the following: (1) all of the content of the associated product label, as specified in this rule and identified in Table 8; (2) a batch number or code that is associated with the cannabis used for the manufacture of the product, that is recorded by a non-profit producer in the electronic tracking system specified by the department; (3) pesticide(s) used in the production of the cannabis or cannabis-derived product; (4) for dried, usable cannabis and edible cannabis products: the total of THC, THCA, CBD, and CBDA per package, which shall be expressed by percentage of weight; (5) for concentrated cannabis derived product: the totals of THC, THCA, CBD, and CBDA per package, which shall each be expressed by weight in milligrams and by percentage of total weight; (6) for non-concentrated cannabis derived product: the total of THC, THCA, CBD, and CBDA, both per serving and per package, w

HC, THCA, CBD, and CBDA per package, which shall be expressed by percentage of weight; (5) for concentrated cannabis derived product: the totals of THC, THCA, CBD, and CBDA per package, which shall each be expressed by weight in milligrams and by percentage of total weight; (6) for non-concentrated cannabis derived product: the total of THC, THCA, CBD, and CBDA, both per serving and per package, which shall each be expressed by weight in milligrams; (7) a “best by” date or freeze date for products capable of supporting the growth of infectious, toxigenic, or spoilage microorganisms; (8) instructions for appropriate storage; (9) complete list of product ingredients; (10) product facts or a nutrition fact panel, a statement that the product is for medical use by qualified patients, and a statement that the product is not for resale; and (11) allergy warnings, including but not limited to information regarding whether the contents of the package were processed in any facility that also processes nuts. Table 9. Sample Drug Information Sheet for Usable Cannabis Products Cannabis Facts Product name: Product strain: Producer of cannabis: Manufacturer of cannabis product: Net product weight: Total units: Manufacture date: Product expiration date: Batch number or code for manufactured product: Batch number or code for cannabis: Instructions for use: Instructions for storage: Nutrition facts: Product ingredients: Allergy warnings: Laboratory Analysis PER CONTAINER: THC: mg / % THC: % 7.34.4 NMAC 29 THCA: mg / % THCA % CBD: mg / % CBD: % CBDA: mg / % CBDA % Testing laboratory: WARNING: This product contains medical cannabis. This product is for medical use by qualified patients only. This product is not for resale. Do not drive a vehicle or operate heavy machinery while under the influence of this product. Consumption of THC when pregnant, or by a mother who is breastfeeding, may adversely impact an infant’s development

/ % CBD: % CBDA: mg / % CBDA % Testing laboratory: WARNING: This product contains medical cannabis. This product is for medical use by qualified patients only. This product is not for resale. Do not drive a vehicle or operate heavy machinery while under the influence of this product. Consumption of THC when pregnant, or by a mother who is breastfeeding, may adversely impact an infant’s development. WARNING: Vaping THC has been associated with cases of severe lung injury, leading to difficulty breathing, hospitalization, and even death. KEEP OUT OF REACH OF CHILDREN. D. Expiration date: An expiration date that is identified on a usable cannabis product label shall not be modified, removed, or obscured. In the event that an expiration date specified on a usable cannabis product label has passed, the product shall be wasted in accordance with the terms of this rule and deducted from inventory in the electronic tracking system specified by the department. E. Failure to comply with packaging or labeling requirements: If a non-profit producer does not comply with any packaging or labeling requirement of this rule, the department may immediately suspend sales and distribution of any such non-compliant product, may order the recall of any such product, may order the relabeling of any such product, and may pursue disciplinary action in accordance with this rule. [7.34.4.16 NMAC - Rp. 7.34.4.14 NMAC, 6/23/2020] 7.34.4.17 DEPARTMENT-APPROVED TESTING LABORATORIES; GENERAL PROVISIONS: A laboratory applicant shall comply with the application requirements of this rule, and shall submit such other information as the laboratory applicant wishes to provide or such information as the department may request for initial approval and periodic evaluations during the approval period. A

- Rp. 7.34.4.14 NMAC, 6/23/2020] 7.34.4.17 DEPARTMENT-APPROVED TESTING LABORATORIES; GENERAL PROVISIONS: A laboratory applicant shall comply with the application requirements of this rule, and shall submit such other information as the laboratory applicant wishes to provide or such information as the department may request for initial approval and periodic evaluations during the approval period. A. Testing categories: A laboratory may apply to become approved by the department as an approved laboratory for the testing of cannabis and cannabis derived products in all or any one of the following categories: (1) mycotoxin analysis; (2) microbiological contaminant analysis; (3) solvent residue analysis; (4) quantity of THC and CBD; and (5) such other testing categories as the department may identify. B. Fee: A laboratory applicant shall submit to the program with each initial application and renewal application for continued approval a non-refundable application fee of two-thousand-two-hundred dollars ($2,200), payable to the medical cannabis program. C. Application materials: A laboratory applicant shall submit to the program with each initial application and renewal application for continued approval the following: (1) standard operating procedures to be followed by the laboratory, including but not limited to policies and procedures to be used in performing analysis of samples; (2) a description of the type of tests to be conducted by the laboratory applicant, which may include, but are not limited to, testing for microbiological contaminants, mycotoxins, solvent residue, THC content, CBD content, identity, purity, strength, composition, or nutritional content, and other quality factors; (3) quality control criteria for the test(s) that the applicant intends to conduct; (4) evidence that validates the accuracy of the test(s) to be conducted by the laboratory applicant as performed in the applicant’s laboratory; (5) proof that the laboratory applicant is in good standing with the New Mexico taxation and revenue dep

th, composition, or nutritional content, and other quality factors; (3) quality control criteria for the test(s) that the applicant intends to conduct; (4) evidence that validates the accuracy of the test(s) to be conducted by the laboratory applicant as performed in the applicant’s laboratory; (5) proof that the laboratory applicant is in good standing with the New Mexico taxation and revenue department; THC NM ! THC NM ! 7.34.4 NMAC 30 (6) copies of the laboratory applicant articles of incorporation and by-laws, as applicable; (7) a list of all persons or business entities having direct or indirect authority over the management or policies of the laboratory applicant; (8) a list of all persons or business entities having any ownership interest in any property utilized by the laboratory 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; (9) a description of the facilities and equipment that shall be used in the operation of the laboratory applicant; (10) a description of how the laboratory applicant will ensure and document chain of custody of any samples held or tested by the laboratory; (11) a general written security policy, to address at a minimum safety and security procedures; (12) an attestation that no firearms will be permitted on any premises used by the laboratory applicant; (13) a description of the methods and device or series of devices that shall be used to provide security; (14) training documentation prepared for each employee of the laboratory 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) personnel records for each employee of the laboratory applicant that include an application for employment and a record of any disciplinary action taken; (16) employee safety and security training materials provided to

, 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) personnel records for each employee of the laboratory applicant that include an application for employment and a record of any disciplinary action taken; (16) employee safety and security training materials provided to each employee of the laboratory applicant at the time of his or her initial appointment, to include training in the proper use of security measures and controls that have been adopted, and specific procedural instructions regarding how to respond to an emergency, including robbery or a violent accident; (17) documented proof of required initial and continuing demonstrations of capability, in accordance with this rule; (18) proof that no buildings to be used by the applicant 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; (19) an attestation that the laboratory will not operate in any location within 300 feet of a school, church or daycare center; and (20) such other materials as the department may require. D. Materials to be maintained on premises: An approved laboratory shall maintain on its premises, and shall promptly present to the department upon request: (1) personnel documentation including, but not limited to employment records, job descriptions, education, and training requirements of the laboratory, and documentation of education and training provided to staff for the purpose of performance of assigned functions; (2) requirements concerning laboratory operations, business licensing, and security procedures; (3) standards for receipt, handling, and disposition of samples of usable cannabis; (4) equipment information detailing the type of

education, and training requirements of the laboratory, and documentation of education and training provided to staff for the purpose of performance of assigned functions; (2) requirements concerning laboratory operations, business licensing, and security procedures; (3) standards for receipt, handling, and disposition of samples of usable cannabis; (4) equipment information detailing the type of equipment used, inspection standards and practices, testing and calibration schedules and records, and standards for cleaning and maintenance of equipment; (5) reagents, solutions, and reference standards including, but not limited to standards for labeling, storage, expiration, and re-qualification dates and records; (6) reference standards, acquired or internally produced, including the certificate of analysis; (7) sample analysis procedures including but not limited to procedures for the use of only primary or secondary standards for quantitative analyses; (8) documentation demonstrating that the analytical methods used by the laboratory are appropriate for their intended purpose; that staff is proficient in the process; and that deviations from approved standards of practice do not occur without proper authorization; (9) standards for data recording, review, storage, and reporting that include, but are not limited to standards to ensure: (a) that data is recorded in a manner consistent with this rule, and that it is reviewed to verify that applicable standards of practice, equipment calibration, and reference standards were applied before reporting; 7.34.4 NMAC 31 (b) that all data, including raw data, documentation, protocols, and reports are retained in accordance with the requirements of this rule; and (c) that reports are the property of the business or individual who provided the sample, and reports meet the requirements of this rule. (10) current material safety data sheets for all chemicals used; and (11) such other materials as the department may require. E

all data, including raw data, documentation, protocols, and reports are retained in accordance with the requirements of this rule; and (c) that reports are the property of the business or individual who provided the sample, and reports meet the requirements of this rule. (10) current material safety data sheets for all chemicals used; and (11) such other materials as the department may require. E. Proficiency testing and inspection: (1) A laboratory applicant shall be subject to proficiency testing by the department or its designee prior to approval, and an approved laboratory shall be subject to proficiency testing, at a frequency and at times to be determined by the program director or designee. A laboratory applicant or approved laboratory shall cooperate with the department or its designee for purposes of conducting proficiency testing. The department or its designee may require submission of cannabis and cannabis-derived product samples from licensed non-profit producers and approved manufacturers for purposes of proficiency testing. (2) A laboratory applicant and an approved laboratory shall be subject to inspection(s), at times determined by the program director or designee, in accordance with the provisions of this rule. The department may require the inspection of premises, equipment, and written materials to determine compliance with this rule, and to determine compliance with the application submissions of the laboratory applicant or approved laboratory, including but not limited to standard operating procedures and standards for testing. (3) Failure of proficiency testing: If the department determines on the basis of a proficiency test that a laboratory applicant has not satisfactorily identified the presence, quantity, or other relevant factor(s) pertaining to a given analyte, the department may deny the application in whole or in part, require additional tests, or require remedial actions to be taken by the laboratory applicant

(3) Failure of proficiency testing: If the department determines on the basis of a proficiency test that a laboratory applicant has not satisfactorily identified the presence, quantity, or other relevant factor(s) pertaining to a given analyte, the department may deny the application in whole or in part, require additional tests, or require remedial actions to be taken by the laboratory applicant. If the department determines on the basis of a proficiency test that an approved laboratory has not satisfactorily identified the presence, quantity, or other relevant factor(s) pertaining to a given analyte, the department may withdraw approval of the laboratory in whole or in part, require additional tests, or require remedial actions to be taken by the approved laboratory. F. Retention and inspection of testing records: An approved laboratory shall retain all results of laboratory tests conducted on cannabis or cannabis derived products for a period of at least two years and shall make them available to the program upon the program’s request. G. Identification cards: An employee of an approved laboratory 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 the termination of the holder’s employment with the approved laboratory, upon suspension, or revocation, or upon demand of the department. H

ain 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 the termination of the holder’s employment with the approved laboratory, upon suspension, or revocation, or upon demand of the department. H. Reporting of theft to department: A laboratory shall submit to the department notification of any theft, robbery, break-in, or security breach that occurs on the laboratory’s premises, no later than 10 calendar days after the laboratory 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. Term of approval: Department approval of a laboratory for purposes of this rule shall be for a term of one year, and shall expire after that year, or upon closure of the approved laboratory. An approved laboratory shall apply for renewal of approval annually no later than 60 days prior to expiration. J. Amended license: (1) An approved laboratory 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 laboratory’s facilities, change of directors, change of ownership of the laboratory’s facilities, change of company name, and any physical modification or addition to the laboratory’s facilities; and (b) substantial change to the laboratory’s standard operating procedures or substantial change to the types of tests to be conducted. (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

tory’s facilities; and (b) substantial change to the laboratory’s standard operating procedures or substantial change to the types of tests to be conducted. (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 laboratory does not submit the requested information or material, and does not otherwise contact the department regarding the application, within thirty days of receiving 7.34.4 NMAC 32 notice of the deficiency, the application will be closed as incomplete, and the laboratory will be required to resubmit the application in order to recommence the application process. K. Termination: The department may deny, withdraw, or suspend approval of a laboratory in accordance with this rule, upon determination by the department that the laboratory has violated a provision of this rule, upon failure of a proficiency test, upon the refusal of the laboratory to provide requested access to premises or materials, or upon the failure of a laboratory to comply with any standard, procedure, or protocol developed, submitted, or maintained pursuant to this rule. [7.34.4.17 NMAC - Rp. 7.34.4.15 NMAC, 6/23/2020] 7.34.4.18 DEPARTMENT-APPROVED TESTING LABORATORIES; GENERAL OPERATIONAL REQUIREMENTS: A. Receipt of test samples: An approved laboratory may receive test samples of cannabis or cannabis derived products from any licensed producer, qualified patient or primary caregiver, and shall apply the testing standards of this rule, including the testing parameters, action levels, reporting levels, and other criteria identified in Tables 1 through 6, to determine whether a sample passes a given test. B

t of test samples: An approved laboratory may receive test samples of cannabis or cannabis derived products from any licensed producer, qualified patient or primary caregiver, and shall apply the testing standards of this rule, including the testing parameters, action levels, reporting levels, and other criteria identified in Tables 1 through 6, to determine whether a sample passes a given test. B. Testing policies: An approved laboratory or laboratory applicant shall establish and implement policies for sample preparation, documentation, and transport, including: (1) accepted test sample types; (2) minimum test sample size; (3) recommended test sample container; (4) test sample labeling; (5) transport and storage conditions, such as refrigeration, as appropriate; (6) other requirements, such as use of preservatives, inert gas, or other measures designed to protect sample integrity; and (7) creation of chain of custody documentation for each sample. C. Recording of samples received: An approved laboratory shall: (1) record the receipt of every test sample received, the record of which shall include: (a) the name and contact information of the licensed producer that was the source of the sample; (b) an appropriately specific description of the sample; (c) the date of receipt of the sample; (d) a statement of the quantity (weight, volume, number, or other amount) of the sample; and (e) a batch number or code that is associated with the product batch and that is recorded by the non-profit producer or manufacturer in the electronic tracking system specified by the department. (2) inform each licensed producer or individual who submits a test sample of the policies established in accordance with this section. D. Sample handling, storage and disposal: An approved laboratory shall establish sample handling procedures for the tracking of test samples through the analytical process (by weight, volume, number, or other appropriate measure) to prevent diversion

he department. (2) inform each licensed producer or individual who submits a test sample of the policies established in accordance with this section. D. Sample handling, storage and disposal: An approved laboratory shall establish sample handling procedures for the tracking of test samples through the analytical process (by weight, volume, number, or other appropriate measure) to prevent diversion. (1) An approved laboratory shall store each test sample under the appropriate conditions to protect the physical and chemical integrity of the sample. (2) Analyzed test samples consisting of cannabis or cannabis-derived product shall be appropriately segregated, controlled, and held in a controlled access area pending destruction or other disposal. (3) Any portion of a cannabis or cannabis-derived test sample that is not destroyed during analysis shall be: (a) returned to the licensed producer who provided the sample; or (b) destroyed in accordance with the wastage requirements of this rule. E. State and local laws: An approved laboratory and a laboratory applicant shall comply with all applicable state and local laws, including but not limited to zoning, occupancy, licensing, and building codes. F. Laboratory premises: An approved laboratory and a laboratory applicant shall maintain the premises of the laboratory in a clean and orderly condition; shall equip the premises with such utensils and equipment as necessary to conduct the operations of the laboratory; and shall ensure adequate space for laboratory operations, sample storage, and document storage. G. Storage: An approved laboratory and a laboratory applicant shall be equipped with one or more secure, controlled access areas for storage of cannabis and cannabis-derived product test samples, cannabis-derived 7.34.4 NMAC 33 waste, and reference standards. Access to such storage areas shall be limited by the laboratory to authorized individuals. H

erations, sample storage, and document storage. G. Storage: An approved laboratory and a laboratory applicant shall be equipped with one or more secure, controlled access areas for storage of cannabis and cannabis-derived product test samples, cannabis-derived 7.34.4 NMAC 33 waste, and reference standards. Access to such storage areas shall be limited by the laboratory to authorized individuals. H. Equipment: (1) Equipment used for the analysis of test samples shall be adequately inspected, cleaned, and maintained. Equipment used for the generation or measurement of data shall be adequately tested and calibrated on an appropriate schedule, as applicable. (2) Laboratory operations shall document procedures setting forth in sufficient detail the methods and schedules to be used in the routine inspection, cleaning, maintenance, testing, and calibration of equipment, and shall specify, as appropriate, remedial action to be taken in the event of failure or malfunction of equipment. The procedures shall designate the personnel responsible for the performance of each operation. (3) Records shall be maintained of all inspection, maintenance, testing, and calibrating operations. These records shall include the date of the operation, the person who performed it, the written procedure used, and any deviations from the written procedure. Records shall be kept of non-routine repairs performed on equipment as a result of failure and malfunction. Such records shall document the nature of the repair, how and when the need for the repair was discovered, and any remedial action taken in response to the repair

he date of the operation, the person who performed it, the written procedure used, and any deviations from the written procedure. Records shall be kept of non-routine repairs performed on equipment as a result of failure and malfunction. Such records shall document the nature of the repair, how and when the need for the repair was discovered, and any remedial action taken in response to the repair. (4) Computer systems used for the analysis of samples, retention of data, sample tracking, calibration scheduling, management of reference standards, or other critical laboratory management functions shall ensure that electronic records, electronic signatures, and handwritten signatures executed to electronic records are trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. I. Reagents, solutions, and reference standards: (1) An approved laboratory is authorized to possess reagents, solutions, and reference standards. Such items shall be: (a) secured in accordance with the approved laboratory’s storage policies; labeled to indicate identity, date received or prepared, and expiration or requalification date; and, where applicable, concentration or purity, storage requirements, and date opened; (b) stored under appropriate conditions to minimize degradation or deterioration of the material; and (c) used only within the item’s expiration or requalification date. (2) Deteriorated or outdated reagents and solutions shall be properly destroyed. (3) An approved laboratory may acquire commercial reference standards for cannabinoids and other chemicals or contaminants, for the exclusive purpose of conducting testing for which the laboratory is approved. An approved laboratory may elect to internally produce reference standards. When internally produced, an approved laboratory shall utilize standard analytical techniques to document the purity and concentration of the internally produced reference standards

ds for cannabinoids and other chemicals or contaminants, for the exclusive purpose of conducting testing for which the laboratory is approved. An approved laboratory may elect to internally produce reference standards. When internally produced, an approved laboratory shall utilize standard analytical techniques to document the purity and concentration of the internally produced reference standards. An approved laboratory is authorized to obtain cannabis or cannabis- derived product from a licensed non-profit producer for this purpose. (4) An approved laboratory shall obtain or, for internally-produced standards, shall create a certificate of analysis (COA) for each lot of reference standard. Each COA shall be kept on file and the lot number of the reference standard used shall be recorded in the documentation for each analysis, as applicable. J. Analysis: An approved laboratory shall: (1) utilize analytical methods that are appropriate for the purpose of testing cannabis and cannabis-derived products; (2) require analysts to demonstrate proficiency in the performance of the analytical methods used; (3) maintain written procedures for the analytical method used for the analysis of each test sample, including: (a) sample preparation; (b) reagent, solution, and reference standard preparation; (c) instrument setup, as applicable; (d) standardization of volumetric reagent solutions, as applicable; (e) data acquisition; and (f) calculation of results. (4) specify, as applicable to each analytical method used, requirements for accuracy, precision, linearity, specificity, limit of detection, limit of quantitation, and other data quality parameters; (5) ensure that no deviations from approved protocols or standard operating procedures are made during any analytical process without proper authorization and documentation; and (6) use only primary standards or secondary standards for quantitative analyses. 7.34.4 NMAC 34 K

r accuracy, precision, linearity, specificity, limit of detection, limit of quantitation, and other data quality parameters; (5) ensure that no deviations from approved protocols or standard operating procedures are made during any analytical process without proper authorization and documentation; and (6) use only primary standards or secondary standards for quantitative analyses. 7.34.4 NMAC 34 K. Recording of analytical data: (1) An approved laboratory shall ensure that all data generated during the testing of a test sample, except data generated by automated data collection systems, is recorded directly, promptly, and legibly in ink. All data shall be annotated with the date of entry and signed or initialed by the person recording the data. Any change in entries shall be made so as not to obscure the original entry, shall indicate the reason for such change, and shall be dated and signed or initialed at the time of the change. (2) In automated data collection systems, the individual responsible for direct data input shall be identified at the time of data input. Any change in an entry shall be made so as not to obscure the original entry, shall indicate the reason for such change, and shall be dated and signed or initialed at the time of the change. A corrective action report (CAR) shall accompany such change and shall be made available to the department, a non- profit producer, and a manufacturer upon their request for up to two years after the analysis is completed

n an entry shall be made so as not to obscure the original entry, shall indicate the reason for such change, and shall be dated and signed or initialed at the time of the change. A corrective action report (CAR) shall accompany such change and shall be made available to the department, a non- profit producer, and a manufacturer upon their request for up to two years after the analysis is completed. (3) For each final result reported, an approved laboratory shall verify that: (a) any calculations or other data processing steps were performed correctly; (b) the data meet any data quality requirements such as for accuracy, precision, linearity, etc.; (c) any reference standards used were of the appropriate purity and within their expiration or requalification dates; (d) any volumetric solutions were properly standardized before use; and (e) any test or measuring equipment used has been properly tested, verified, and calibrated, and is within its verification or calibration period. L. Data storage: (1) An approved laboratory shall ensure that all raw data, documentation, protocols, and final reports associated with analysis of a test sample are retained for two years from the date of the completion of analysis. (2) An approved laboratory shall maintain the records identified in this section. Such records must be maintained: (a) in a manner that allows retrieval as needed; (b) under conditions of storage that minimize deterioration throughout the retention period; and (c) in a manner that prevents unauthorized alteration. M. Records maintenance and access: An approved laboratory or laboratory applicant shall designate an individual as responsible for records maintenance. Only authorized personnel may access the maintained records. N

that allows retrieval as needed; (b) under conditions of storage that minimize deterioration throughout the retention period; and (c) in a manner that prevents unauthorized alteration. M. Records maintenance and access: An approved laboratory or laboratory applicant shall designate an individual as responsible for records maintenance. Only authorized personnel may access the maintained records. N. Data reporting: (1) Contents of report: A laboratory report of a test conducted at the request of a licensed producer or qualified patient shall contain the following information: (a) the date of receipt of the test sample; (b) the description of the type or form of the test sample (leaf, flower, powder, oil, specific edible product, etc.); (c) the batch number or code that is associated with the product batch and that is recorded in the electronic tracking system specified by the department; (d) information on whether sampling was performed by the laboratory operation, by the compliant business or individual which submitted the test sample, or by a third-party; (e) date on which analysis occurred; (f) the analytical method used, including at a minimum identification of the type of analytical equipment used (e.g., GC, HPLC, UV, etc.); (g) the analytical results, including units of measure where applicable; (h) the identity of the supervisory or management personnel who reviewed and verified the data and results and ensured that data quality, calibration, and other applicable requirements were met; and (i) the name, address, and contact information of the approved laboratory that conducted the test. (2) The laboratory report shall state that reported analytical results apply only to the test sample received. O. Department access to materials and premises: An approved laboratory shall promptly provide the department or the department’s designee access to a report of a test, and any underlying data, that is conducted 7.34.4 NMAC 35 on a sample at the request of a licensed producer or qualified patient

laboratory report shall state that reported analytical results apply only to the test sample received. O. Department access to materials and premises: An approved laboratory shall promptly provide the department or the department’s designee access to a report of a test, and any underlying data, that is conducted 7.34.4 NMAC 35 on a sample at the request of a licensed producer or qualified patient. An approved laboratory shall also provide access to the department or the department’s designee to laboratory premises, and to any material or information requested by the department, for the purpose of determining compliance with the requirements of this rule. P. Drugs and alcohol: A laboratory shall prohibit its employees and contractors from being under the influence of drugs or alcohol in the workplace. Q. Failures to meet testing requirements: Repeated failures by a laboratory to comply with the testing requirements of department rule may result in disciplinary action against the laboratory. [7.34.4.18 NMAC - Rp. 7.34.4.16 NMAC, 6/23/2020] 7.34.4.19 DEPARTMENT-APPROVED TESTING LABORATORIES; INSTRUMENTATION; INITIAL AND CONTINUING DEMONSTRATIONS OF CAPABILITY: A. Mycotoxin test instrumentation: A laboratory shall utilize HPLC, LCMS, or LCMSMS instrumentation to test for the presence of mycotoxins in usable cannabis and shall analyze for mycotoxins at a concentration as low as 1 µg/kg (ppb). Mycotoxin testing shall be conducted in accordance with the requirements of Table 2, Mycotoxins Testing Requirements. B. Residual solvents test instrumentation: A laboratory shall utilize gas chromatography – flame ionization detector (GC-FID), gas chromatography tandem photoionization detector/flame ionization detector (GC- PID/FID), or GCMS instrumentation to test for the presence of residual solvents and shall analyze for residual solvents at a concentration as low as 2µg/g (ppm). Residual solvent testing shall be conducted in accordance with the requirements of Table 3, Residual Solvent Testing Requirements. C

tion detector (GC-FID), gas chromatography tandem photoionization detector/flame ionization detector (GC- PID/FID), or GCMS instrumentation to test for the presence of residual solvents and shall analyze for residual solvents at a concentration as low as 2µg/g (ppm). Residual solvent testing shall be conducted in accordance with the requirements of Table 3, Residual Solvent Testing Requirements. C. Potency test instrumentation: A laboratory shall utilize HPLC or LCMS instrumentation to test for potency in usable cannabis and shall analyze usable cannabis in accordance with the provisions at Table 4 Potency Testing Requirements. D. Heavy metals test instrumentation: A laboratory shall utilize Inductively coupled plasma mass spectrometry (ICP-MS) or flow injection mercury system (FIMS) instrumentation to test for the presence of heavy metals in usable cannabis and shall analyze for heavy metals at a concentration as low as 0.2 µg/g (ppm) for lead (Pb) and cadmium (Cd), as low as 1.0 µg/g (ppm) for arsenic (As) and 0.1 µg/g (ppm) for mercury (Hg). Heavy metals testing shall be conducted in accordance with the requirements of Table 5, Heavy Metals Testing Requirements. E. Pesticide test instrumentation: A laboratory shall utilize high performance liquid chromatography (HPLC), gas chromatography mass spectrometry (GCMS), liquid chromatography - mass spectrometry (LCMS), or liquid chromatography with tandem mass spectrometry (LCMSMS) instrumentation to test for the presence of pesticides in usable cannabis and shall analyze for pesticides at a concentration as low as 100 µg/kg (ppb). Pesticide testing shall be conducted in accordance with the provisions of Table 6, Pesticide Testing Requirements. F. Initial and continuing demonstrations of capability required: A laboratory or laboratory applicant shall submit to the department an initial demonstration of capability (IDC) for every test identified in this rule that the laboratory or applicant intends to conduct

100 µg/kg (ppb). Pesticide testing shall be conducted in accordance with the provisions of Table 6, Pesticide Testing Requirements. F. Initial and continuing demonstrations of capability required: A laboratory or laboratory applicant shall submit to the department an initial demonstration of capability (IDC) for every test identified in this rule that the laboratory or applicant intends to conduct. A laboratory shall submit a continuing demonstration of capability (CDC) annually as part of the laboratory’s application for renewal of licensure. The IDC shall be submitted to the department prior to the laboratory or laboratory applicant conducting tests pursuant to this rule. Each IDC and CDC shall describe how quality control samples (negative control samples, positive control samples, low-positive controls, and instrument performance check controls), internal standards, and surrogate standards are to be assessed to determine if the data from an analytical batch are acceptable. The laboratory shall maintain a documented procedure for performing every IDC and CDC. The laboratory shall retain documentation verifying the IDC and CDC for each test required by this rule and make this documentation available to the department upon request. The IDC and CDCs shall follow the same parameters as outlined in the requirements of this rule. Every IDC and CDC that is submitted shall be conducted within one year of application (excluding mycotoxins). (1) An IDC shall be reconducted and resubmitted to the department: (a) whenever there is a change in method; (b) whenever an instrument has been moved; (c) whenever a new instrument is installed; and (d) whenever the method has not been performed by the laboratory or sampler within a 12-month period. (2) Every IDC and CDC shall include the following elements: (a) Demonstration of method calibration: The calibration range shall use at least five calibration points consisting of five different concentration levels of target compounds

as been moved; (c) whenever a new instrument is installed; and (d) whenever the method has not been performed by the laboratory or sampler within a 12-month period. (2) Every IDC and CDC shall include the following elements: (a) Demonstration of method calibration: The calibration range shall use at least five calibration points consisting of five different concentration levels of target compounds. The calibration range 7.34.4 NMAC 36 shall include a low calibration point equal to, or less, than the required minimum reporting level for each targeted compound. The calibration range shall include a calibration point equal to the action level for each targeted compound (mycotoxins and residual solvents). A laboratory or laboratory applicant shall provide the equation and the type of curve fit used for the calibration range, and the percent relative standard deviation or the goodness of fit. The percent relative standard deviation shall be less than twenty percent, or the goodness of fit (correlation coefficient) shall be 0.995 or better. (b) Demonstration of method accuracy and precision: A laboratory or laboratory applicant shall supply the quantitation data for five positive control samples analyzed by its testing method utilizing a median or mid-level calibration concentration. A laboratory or laboratory applicant shall calculate and provide the calculated mean (average) result and the standard deviation. The percent relative standard deviation shall be less than fifteen percent, and the mean shall be within fifteen percent of the expected concentration. For laboratories using GC-FID, GC-PID/FID, or GCMS platforms for residual solvents, the percent relative standard deviation may be within twenty percent, and the mean may be within twenty percent, of the expected concentration for the targeted compounds propane, n-butane, isobutane, and methanol

less than fifteen percent, and the mean shall be within fifteen percent of the expected concentration. For laboratories using GC-FID, GC-PID/FID, or GCMS platforms for residual solvents, the percent relative standard deviation may be within twenty percent, and the mean may be within twenty percent, of the expected concentration for the targeted compounds propane, n-butane, isobutane, and methanol. (c) Demonstration of method detection limit: A laboratory or laboratory applicant shall supply the quantitation data of seven low-level or minimum action level positive control samples. The concentration of these low-level positive control samples is set equal to the lowest calibration point the laboratory uses. These data are then used to calculate a standard deviation, which is then used to calculate method detection limit (MDL) using the following equation: (3.14267 x standard deviation = method detection limit). The calculated method detection limit for each targeted mycotoxin and residual solvent shall be less than the required method reporting level. For potency testing, quantitation values of all the seven low-level positive controls fall within fifty perecent to one hundred and fifty percent% of the expected concentration for the cannabinoids THC, THCA, CBD, and CDBA (d) Demonstration of low system background: A laboratory or laboratory applicant shall supply the analytical data of at least three negative control samples that do not contain any mycotoxins, residual solvents, or cannabinoids. For mycotoxins and residual solvents, the quantitation values shall be less than the minimum detection limit or a non-detect. For potency testing, the quantitation values shall be less than one-third of the value of the method reporting level

applicant shall supply the analytical data of at least three negative control samples that do not contain any mycotoxins, residual solvents, or cannabinoids. For mycotoxins and residual solvents, the quantitation values shall be less than the minimum detection limit or a non-detect. For potency testing, the quantitation values shall be less than one-third of the value of the method reporting level. (e) Demonstration of analyte identification: A laboratory that uses, and a laboratory applicant than intends to use, HPLC, GC-FID, or GC-PID/FID instrumentation shall supply analytical data where each targeted compound is analyzed as a single compound giving it its characteristic retention time. A laboratory that uses, and a laboratory applicant than intends to use, GCMS, LCMS, or LCMSMS instrumentation shall supply analytical data with the characteristic mass spectrum of each targeted compound. G. Use of internal standards: A laboratory shall utilize an internal standard chemical compound in the instrumental analysis (testing methods) of cannabinoids, residual solvents, mycotoxins, heavy metals, and pesticides, which are collectively referred to as the tested analytes. The internal standard compound shall be used to determine the characteristic relative chromatographic retention times of these tested analytes to ensure proper analyte identifications (qualification) whenever mass spectral data are not obtained by an instrument. The internal standard compound shall be used to determine the relative instrument response of the tested analytes to ensure the proper measurement of analyte concentrations (quantitation). H. Reporting results: A laboratory shall use no more than two significant figures to report a positive result. A laboratory shall report a non-detect of an analyte as less than the laboratory’s minimum reporting level. A laboratory shall also report a pass or fail evaluation with the reported result. A pass evaluation is assigned to a reported result less than the analytes action level listed

on). H. Reporting results: A laboratory shall use no more than two significant figures to report a positive result. A laboratory shall report a non-detect of an analyte as less than the laboratory’s minimum reporting level. A laboratory shall also report a pass or fail evaluation with the reported result. A pass evaluation is assigned to a reported result less than the analytes action level listed. A fail evaluation is assigned to a reported result equal to or greater than the action level for each given analysis, consistent with the requirements of this rule. [7.34.4.19 NMAC - N, 6/23/2020] 7.34.4.20 DEPARTMENT-APPROVED COURIERS; GENERAL PROVISIONS: A. Approval of couriers: The department may approve a courier for the purpose of transporting usable cannabis from one or more licensed non-profit producers to qualified patients, primary caregivers, other non- profit producers, approved manufacturers and approved laboratories. B. Application requirements: An applicant who seeks department approval to operate as a courier shall provide the following materials and information to the department in order to be considered for approval; and an approved courier shall promptly submit revisions in the event that the materials or information changes: (1) a plan for delivery; 7.34.4 NMAC 37 (2) a plan for security, including a description of facilities and containers intended for use in storing and transporting usable cannabis; (3) a plan for safety, to include at a minimum a description of measures to be taken by the courier and its employees to ensure the safety of qualified patients, primary caregivers, and courier staff; (4) a description of all vehicles used or intended to be used for the transport of usable cannabis; (5) a complete list of employees; (6) clear, legible photocopies of current New Mexico state-issued identification cards of all courier personnel; (7) completed nationwide and statewide criminal history screening documentation; (8) a description of the courier’s hours of operation; (9) a description of the l

cription of all vehicles used or intended to be used for the transport of usable cannabis; (5) a complete list of employees; (6) clear, legible photocopies of current New Mexico state-issued identification cards of all courier personnel; (7) completed nationwide and statewide criminal history screening documentation; (8) a description of the courier’s hours of operation; (9) a description of the locations or type(s) of locations where the courier will offer delivery of usable cannabis; (10) a description of all licensed non-profit producers for whom the courier will deliver usable cannabis, and copies of all agreements between the courier and licensed non-profit producers for the delivery of usable cannabis; (11) a description of all fees to be charged by the courier; (12) protocols for contacting and communicating with qualified patients and primary caregivers regarding deliveries; (13) training materials for drivers; (14) confidentiality training materials that address the confidentiality of qualified patient and primary caregiver information; (15) proof that the applicant is in good standing with the New Mexico taxation and revenue department (TRD); (16) copies of the applicant’s articles of incorporation or organization, as applicable; (17) copies of the applicant’s by-laws, as applicable; (18) a list of all persons or business entities having direct or indirect authority over the management or policies of the courier, as applicable; (19) a list of all persons or business entities having any ownership interest in any property utilized by the courier, whether direct or indirect, whether the interest is in land, building(s), or other material; (20) proof that no buildings to be used by the courier 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 l

ng(s), or other material; (20) proof that no buildings to be used by the courier 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; (21) if the courier will base its business at a location that is not owned by the applicant: a written statement from the property owner or landlord of the location that grants to the courier permission to possess cannabis on the premises; (22) an attestation that the courier will not distribute cannabis within 300 feet of a school, church or daycare center, in accordance with the provisions of this rule; (23) an attestation that no firearms will be permitted on any premises or in any vehicle used by the courier; and that no employee will possess a firearm when transporting or distributing cannabis; and (24) an attestation that the courier will not transport cannabis across state lines. C. Application fee: A courier applicant shall submit to the program with each initial application and renewal application for continued approval a non-refundable application fee of one-thousand-five-hundred dollars ($1,500), payable to the medical cannabis program. D. General requirements: An approved courier shall adhere to each of the following requirements: (1) a courier may contract with a licensed non-profit producer to deliver usable cannabis from the non-profit producer to qualified patients, primary caregivers, other non-profit producers, approved manufacturers and approved laboratories; a courier that provides service to more than one licensed non-profit producer shall offer their service at a uniform price for all non-profit producers for whom they deliver; an approved courier shall not transport a cannabis product that is not individually packaged, or that is not labeled in accordance with this rule; (2) an approved co

roducers, approved manufacturers and approved laboratories; a courier that provides service to more than one licensed non-profit producer shall offer their service at a uniform price for all non-profit producers for whom they deliver; an approved courier shall not transport a cannabis product that is not individually packaged, or that is not labeled in accordance with this rule; (2) an approved courier shall not request or receive payment from a qualified patient or primary; (3) upon obtaining a package of usable cannabis from a licensed non-profit producer, an approved courier shall hold the package in a secured area or areas that are locked and otherwise resistant to 7.34.4 NMAC 38 tampering or theft, until the package is delivered to its intended recipient or returned to the licensed non-profit producer; (4) an approved courier shall not relinquish possession of usable cannabis unless and until the package of usable cannabis is either successfully delivered or returned to the licensed non-profit producer; for purposes of this section, a package of usable cannabis is successfully delivered only upon the approved courier’s verification that an intended recipient has taken actual, physical possession of the package; an approved courier shall not leave a package at any location for any reason, unless the package is successfully delivered to its intended recipient; (5) an approved courier shall not deliver a package to any person or entity who is not identified by the licensed non-profit producer as an intended, authorized recipient; (6) at the time of delivery, an approved courier shall verify the recipient’s identity by requiring presentation of the recipient’s department-issued medical cannabis identification card and New Mexico- issued photo identification card or a passport; an approved courier shall not deliver usable cannabis to any person whose identity is not verified in accordance with this rule; an approved courier shall document having verified the recipient’s identification in accordance with this rule

requiring presentation of the recipient’s department-issued medical cannabis identification card and New Mexico- issued photo identification card or a passport; an approved courier shall not deliver usable cannabis to any person whose identity is not verified in accordance with this rule; an approved courier shall document having verified the recipient’s identification in accordance with this rule for each transaction; (7) an approved courier shall not possess usable cannabis for a time period greater than seven days; an approved courier shall return any usable cannabis that is not successfully delivered to its intended recipient to a licensed non-profit producer within this time period; (8) an approved courier shall not distribute cannabis at locations that are within 300 feet of a school, church, or daycare center; provided that, for purposes of this provision, delivery to the residence of a qualified patient or primary caregiver shall not be deemed “distribution”; (9) an approved courier and its personnel shall at all times take measures to ensure confidentiality and safety in the transport and delivery of usable cannabis; (10) an approved courier shall appropriately train its personnel regarding the confidentiality of information concerning qualified patients and primary caregivers; confidentiality training shall describe confidentiality requirements applicable under both federal and state law; an approved courier shall conduct confidentiality training of its personnel at least once annually, and shall maintain training materials on its premises, and document the training of individual staff; (11) personnel of an approved courier shall not possess a firearm while distributing or otherwise possessing cannabis; an approved courier shall not possess or permit the possession of a firearm on any premises, including a building or vehicle, utilized by the courier; and (12) an approved courier shall not, when transporting usable cannabis to a qualified patient or primary caregiver, utilize a delivery vehicle that adv

roved courier shall not possess a firearm while distributing or otherwise possessing cannabis; an approved courier shall not possess or permit the possession of a firearm on any premises, including a building or vehicle, utilized by the courier; and (12) an approved courier shall not, when transporting usable cannabis to a qualified patient or primary caregiver, utilize a delivery vehicle that advertises or otherwise displays signage, logos, or symbols that would indicate that the vehicle is used for the transport of cannabis. E. Identification cards: The department shall issue an identification card to each authorized employee of an approved courier authorizing that individual to transport cannabis from a non-profit producer to a qualified patient or primary caregiver. An employee of an approved courier 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 an approved courier’s withdrawal from the program, upon the termination of a card holder’s employment with the approved courier, upon suspension or revocation, or upon demand of the department. F. Term of approval: Department approval of a courier shall be for a term of one year, and shall expire after that year, or upon closure of the courier. A courier shall apply for renewal of approval annually no later than 30 days prior to expiration. G

ram, upon the termination of a card holder’s employment with the approved courier, upon suspension or revocation, or upon demand of the department. F. Term of approval: Department approval of a courier shall be for a term of one year, and shall expire after that year, or upon closure of the courier. A courier shall apply for renewal of approval annually no later than 30 days prior to expiration. G. Amended license: (1) An approved courier 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 courier’s facilities, change of directors, change of ownership of the courier’s facilities, change of company name, and any physical modification or addition to the courier’s facilities; and (b) substantial change to the courier’s methods for storing, transporting and delivering cannabis-derived products, and any substantial change to the courier’s security plan. 7.34.4 NMAC 39 (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 courier 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 courier will be required to resubmit the application in order to recommence the application process. H. Reporting of theft to department: A courier shall submit to the department notification of any theft, robbery, break-in, or security breach that occurs on the courier’s premises, no later than 10 calendar days after the courier 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

of theft to department: A courier shall submit to the department notification of any theft, robbery, break-in, or security breach that occurs on the courier’s premises, no later than 10 calendar days after the courier 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. Drugs and alcohol: A courier shall prohibit its employees and contractors from being under the influence of drugs or alcohol in the workplace. J. Inventory and sales equipment: The department may require a licensed courier to utilize specified equipment, software, and services for purposes of tracking distribution, inventory, and other information, and for the purpose of reporting that information to the department of health. K. Chain of custody: A courier shall adopt, maintain, and enforce chain of custody procedures and documentation requirements to ensure appropriate tracking and inventory of usable cannabis. A courier shall also adopt, maintain, and enforce security requirements to ensure that usable cannabis transported by the courier is secured, and to promote the safety of courier personnel, as well as qualified patients and primary caregivers who receive packages from the courier. L. Confidentiality: An approved courier may obtain contact information of a purchasing qualified patient or primary caregiver, as permitted by agreement between the courier and a respective licensed non-profit producer, and may utilize such information solely for the purpose of arranging a delivery location and time with the qualified patient or primary caregiver. An approved courier shall not otherwise disseminate, disclose, or use identifying information or contact information concerning a qualified patient or primary caregiver. [7.34.4.20 NMAC - Rp. 7.34.4.17 NMAC, 6/23/2020] 7.34.4.21 QUALIFIED PERSONAL PRODUCTION APPLICATION AND LICENSURE REQUIREMENTS: A

purpose of arranging a delivery location and time with the qualified patient or primary caregiver. An approved courier shall not otherwise disseminate, disclose, or use identifying information or contact information concerning a qualified patient or primary caregiver. [7.34.4.20 NMAC - Rp. 7.34.4.17 NMAC, 6/23/2020] 7.34.4.21 QUALIFIED PERSONAL PRODUCTION APPLICATION AND LICENSURE REQUIREMENTS: A. A qualified patient may apply for a personal production license for either the qualified patient or the qualified patient’s primary caregiver to produce medical cannabis solely for the qualified patient’s own use. B. A qualified patient may obtain no more than one personal production license, which license may be issued for production to occur either indoors or outdoors in no more than one single location. C. No more than two personal production licenses may be issued for a given location, with proof that a second registered patient currently resides at the location. Multiple personal production licenses may not be issued for non-residential locations. D. Qualified patients shall provide the following in order to be considered for a personal production license to produce medical cannabis: (1) applicable non-refundable fee; (2) a description of the single indoor or outdoor location that shall be used in the production of cannabis; (3) if the location is on property that is not owned by the applicant: a written statement from the property owner or landlord that grants to the applicant permission to grow cannabis on the premises; (4) a written plan that ensures that the cannabis production shall not be visible from the street or other public areas; (5) a written acknowledgement that the applicant will ensure that all cannabis, cannabis- derived products and paraphernalia is accessible only by the applicant and their primary caregiver (if any), and kept secure and out of reach of children; (6) a description of any device or series of devices that shall be used to provide security and proof of the secure grounds; and (7) a

other public areas; (5) a written acknowledgement that the applicant will ensure that all cannabis, cannabis- derived products and paraphernalia is accessible only by the applicant and their primary caregiver (if any), and kept secure and out of reach of children; (6) a description of any device or series of devices that shall be used to provide security and proof of the secure grounds; and (7) a written acknowledgement of the limitations of the right to use and possess cannabis for medical purposes in New Mexico.