TITLE 7 HEALTH
CHAPTER 34 MEDICAL USE OF CANNABIS
PART 4 LICENSING
REQUIREMENTS FOR PRODUCERS, COURIERS, MANUFACTURERS AND LABORATORIES
7.34.4.1 ISSUING AGENCY: New Mexico Department of Health, Medical
Cannabis Program.
[7.34.4.1
NMAC - Rp, 7.34.4.1 NMAC, 6/23/2020]
7.34.4.2 SCOPE: This rule applies to all licensed producers
of medical use cannabis, defined in Subsection D of Section 26-2B-3 NMSA 1978
as “any person or association of persons within New Mexico that the department
determines to be qualified to produce,
possess, distribute, and dispense cannabis pursuant to the Lynn and Erin
Compassionate Use Act and that is licensed by the department.”
[7.34.4.2 NMAC - Rp, 7.34.4.2 NMAC, 6/23/2020]
7.34.4.3 STATUTORY AUTHORITY: The requirements set forth herein are
promulgated by the secretary of the department of health (DOH) pursuant to the authority granted under Subsection E of Section 9-7-6 NMSA
1978, and the Lynn and Erin Compassionate Use Act, 26-2B-1 et seq., NMSA 1978. Although
federal law currently prohibits any use of cannabis, the laws of several states
permit the medical use and cultivation of cannabis. New Mexico joins this effort to provide for
the health and welfare of its citizens.
New Mexico adopts these regulations to accomplish the purpose of the
Lynn and Erin Compassionate Use Act as stated in Section 26-2B-2 NMSA 1978, “to
allow for the beneficial use of medical cannabis in a regulated system for
alleviating symptoms caused by debilitating medical conditions and their
medical treatments,” while at the same time ensuring proper enforcement of any
criminal laws for behavior that has been deemed illicit by the state.
[7.34.4.3 NMAC - Rp, 7.34.4.3 NMAC, 6/23/2020]
7.34.4.4 DURATION: Permanent.
[7.34.4.4 NMAC - Rp, 7.34.4.4 NMAC, 6/23/2020]
7.34.4.5 EFFECTIVE DATE: June 23,
2020 unless a later date is cited at the end of a section.
[7.34.4.5 NMAC - Rp, 7.34.4.5 NMAC, 6/23/2020]
7.34.4.6 OBJECTIVE: Ensuring the safe production, distribution,
and dispensation of cannabis for the sole purpose of medical use for
alleviating symptoms caused by debilitating
medical conditions in a regulated system.
[7.34.4.6 NMAC - Rp, 7.34.4.6 NMAC, 6/23/2020]
7.34.4.7 DEFINITIONS:
A. Definitions
beginning with “A”:
(1) “Act” means the Lynn and Erin Compassionate Use Act, Sections 26-2B-1 through 26-2B-7 NMSA 1978.
(2) “Adequate supply”
means an amount of cannabis, in any form approved by the department, possessed
by a qualified patient or collectively possessed by a qualified patient and the
qualified patient's primary caregiver that is determined by rule of the
department to be no more than reasonably necessary to ensure the uninterrupted
availability of cannabis for a period of three months and that is derived
solely from an intrastate source.
(3) “Administrative review committee” means
an intra-department committee that reviews qualified patient or primary
caregiver application denials, licensed producer denials made by the program
director, or the summary suspension of a producer’s license, in accordance with
department rules. The administrative
review committee shall consist of the chief medical officer of the department
(or that’s person’s designee); a deputy secretary of the department (or that
person’s designee), and the chief nursing officer of the department (or that
person’s designee).
(4) “Administrative
withdrawal” means the procedure for the voluntary withdrawal of a
qualified patient or primary caregiver from the medical cannabis program.
(5) “Advisory board”
means the medical cannabis advisory board
consisting of nine practitioners
knowledgeable about the medical use of cannabis, who are appointed by the
secretary.
(6) “Applicant” means
any person applying for enrollment or re-enrollment in the medical cannabis
program as a qualified patient, primary caregiver,
or licensed producer.
(7) “Approved
entity” means a manufacturer, laboratory, or courier.
B. Definitions beginning with “B”: “Batch” means,
with regard to usable cannabis, an identified quantity of cannabis no greater
than five pounds that is of the same strain of cannabis, that is harvested
during the same specified time period from the same specified cultivation area,
, and with respect to which the same agricultural practices were utilized,
including the use of any pesticides; and with regard to concentrated and
cannabis-derived product, means an identified quantity that is uniform, that is
intended to meet specifications for identity, strength, and composition, and
that is manufactured, packaged, and labeled during a specified time period
according to a single manufacturing, packaging, and labeling protocol.
C. Definitions beginning with “C”:
(1) “Cannabis” means all parts of the plant Cannabis sativa L. containing
a delta-9-tetrahydrocannabinol concentration of more than three-tenths percent
on a dry weight basis, whether growing or not; the seeds of the plant; the
resin extracted from any part of the plant; and every compound, manufacture,
salt, derivative, mixture or preparation of the plant, its seeds or its resin;
and does not include the mature stalks of the plant; fiber produced from the
stalks; oil or cake made from the seeds of the plant; any other compound,
manufacture, salt, derivative, mixture or preparation of the mature stalks,
fiber, oil or cake; the sterilized seed of the plant that is incapable of
germination; the weight of any other ingredient combined with cannabis to
prepare topical or oral administrations, food, drink or another product; or
hemp.
(2) “Cannabis consumption area” means an area within a licensed nonprofit producer’s premises that is
approved by the department, where cannabis may be consumed by qualified
patients, in accordance with department rules.
(3) “Cannabis-derived product” means a product, other than cannabis itself, which contains or is
derived from cannabis, not including hemp.
(4) “Cannabis establishment” means:
(a) a licensed
cannabis courier;
(b) a licensed
cannabis testing facility;
(c) a licensed
cannabis manufacturer;
(d) a licensed
non-profit producer; or
(e) such other
person that the department may by rule approve for participation in the medical
cannabis program.
(5) “CBD means cannabidiol, a cannabinoid
and the primary non-psychoactive ingredient found in cannabis.
(6) “CBDA” means cannabidiolic acid, a
non-psychoactive ingredient found in cannabis and an acid precursor to CBD.
(7) “Concentrated
cannabis-derived product (“concentrate”)” means a cannabis-derived product
that is manufactured by a mechanical or chemical process that separates any
cannabinoid from the cannabis plant, and that contains (or that is intended to
contain at the time of sale or distribution) no less than thirty-percent THC by
weight.
(8) “Courier” means a cannabis courier as
defined by the Lynn and Erin Compassionate Use Act, Subsection D of Section
26-2B-3 NMSA 1978, that has been approved by the department specifically to
transport usable cannabis and cannabis products within the state of New Mexico,
from a cannabis establishment to a qualified patient, a primary caregiver, or
another cannabis establishment.
D. Definitions beginning
with “D”:
(1) “Debilitating medical condition” means:
(a) cancer;
(b) glaucoma;
(c) multiple sclerosis;
(d) damage to the nervous tissue of
the spinal cord, with objective neurological indication
of intractable spasticity;
(e) epilepsy;
(f) positive status for human
immunodeficiency virus or acquired immune deficiency syndrome;
(g) admission into hospice care in
accordance with rules promulgated by the
department;
(h) amyotrophic
lateral sclerosis;
(i) Crohn’s
disease;
(j) hepatitis
C infection;
(k) Huntington’s
disease;
(l) inclusion
body myositis;
(m) inflammatory
autoimmune-mediated arthritis;
(n) intractable
nausea or vomiting;
(o) obstructive
sleep apnea;
(p) painful
peripheral neuropathy;
(q) Parkinson’s
disease;
(r) posttraumatic
stress disorder;
(s) severe
chronic pain;
(t) severe
anorexia or cachexia;
(u) spasmodic
torticollis;
(v) ulcerative
colitis; or
(w) any
other medical condition, medical treatment, or disease as approved by the
department which results in pain, suffering, or debility for which there is
credible evidence that medical use cannabis could be of benefit.
(2) “Department”
means the department of health or its agent.
(3) “Diversion” means the unlawful transfer
of a cannabis plant, plant material, or cannabis-derived product.
(4) “Dried usable cannabis” means the dried leaves, flowers, and trim of the female
cannabis plant, but does not include the seeds, stalks, or roots of the
cannabis plant.
E. Definitions
beginning with “E”: [RESERVED]
F. Definitions beginning with “F”: “Facility”
means any building, space, or grounds licensed for the production, possession,
testing, manufacturing, or distribution of cannabis, concentrates, or
cannabis-derived products.
G. Definitions
beginning with “G”: [RESERVED]
H. Definitions
beginning with “H”: “Hemp” means the plant cannabis sativa L.
and any part of the plant, whether growing or not, containing a
delta-9-tetrahydrocannabinol concentration of no more than three-tenths percent
on a dry weight basis.
I. Definitions
beginning with “I”:
(1) “Intrastate” means existing or occurring within the state boundaries of
New Mexico.
(2) “Inversion”
means the unlawful acquisition of a cannabis plant, plant material, or
cannabis-derived product.
J. Definitions
beginning with “J”: [RESERVED]
K. Definitions beginning with “K”: [RESERVED]
L. Definitions
beginning with “L”:
(1) “Laboratory” means a licensed cannabis testing facility as defined in the Lynn and
Erin Compassionate Use Act, Subsection I of Section 26-2B-3 NMSA 1978, that has been approved by the department specifically for the
testing of cannabis, concentrates, and cannabis derived products.
(2) “Laboratory applicant” means a
laboratory that seeks to become an approved laboratory, or that seeks renewal
of approval as an approved laboratory, in accordance with this rule.
(3) “Licensed producer”
means a person or entity licensed to produce medical cannabis.
(4) “Lot” means an identified portion of a batch, that is uniform and that is
intended to meet specifications for identity, strength, and composition; or, in
the case of a cannabis-derived product or concentrate, an identified quantity
produced in a specified period of time in a manner that is uniform and that is
intended to meet specifications for identity, strength, and composition.
M. Definitions
beginning with “M”:
(1) “Male plant”
means a male cannabis plant.
(2) “Manufacture” means to prepare a
cannabis product.
(3) “Manufacturer”
means a cannabis manufacturer as defined in the Lynn and Erin Compassionate Use
Act, Subsection F of Section 26-2B-3 NMSA 1978, that has been approved by the
department specifically to manufacture cannabis products; package, transport or
courier cannabis products; have cannabis products tested by a cannabis testing
facility; purchase, obtain, sell and transport cannabis products to other
cannabis establishments; and prepare products for personal production license
holders.
(4) “Mature
female plant” means a harvestable female cannabis
plant that is flowering.
(5) “Medical
cannabis program” means the administrative body of the department charged with the management of the medical cannabis program and
enforcement of program regulations, to include issuance of registry
identification cards, licensing of producers, and regulation of manufacturing
and distribution.
(6) “Medical
cannabis program director” means the administrator of the medical
cannabis program who holds that title.
(7) “Medical
director” means a medical practitioner designated by the department to determine whether the medical condition of an
applicant qualifies as a debilitating medical condition eligible for enrollment
in the program, and to perform other duties.
(8) “Medical
provider certification for patient eligibility form” means a written
certification form provided by the medical cannabis
program signed by a patient's practitioner that, in the practitioner's
professional opinion, the patient has a debilitating medical condition as
defined by the act or this part and would be anticipated to benefit from the
use of cannabis.
(9) “Minor”
means an individual who is less than 18 years of age.
N. Definitions beginning with “N”: “Non-profit producer” means a New Mexico
corporation that has been designated as a non-profit corporation by the New
Mexico secretary of state, that has been licensed by the department to possess,
produce, dispense, distribute and manufacture cannabis and cannabis products
and sell wholesale or by direct sale to qualified patients and primary
caregivers.
O. Definitions beginning with “O”: [RESERVED]
P. Definitions beginning with “P”:
(1) “Paraphernalia” means any
equipment, product, or material of any kind that is primarily intended or
designed for use in compounding, converting, processing, preparing, inhaling, or otherwise introducing cannabis or its
derivatives into the human body.
(2) “Patient
enrollment/re-enrollment form” means the registry identification
card application form for patient applicants provided by the medical cannabis
program.
(3) “Permanent structure” means a building
or structure that is placed on the land for the foreseeable future that is
anchored to a permanent foundation, that is roofed and walled, and which
requires a building permit from a local and or state governing authority.
(4) “Personal production license” means a license issued to a qualified patient or to a qualified patient’s
primary caregiver participating in the medical cannabis program to permit the
qualified patient or the qualified patient's primary caregiver to produce
cannabis for the qualified patient's use at an address approved by the
department.
(5) “Pesticide”
means a pesticide as defined by the New Mexico Pesticide Control Act, Section
76-4-3, NMSA 1978.
(6) “Petitioner”
means any New Mexico resident or association of New Mexico residents
petitioning the advisory board for the inclusion of a new medical condition, medical treatment, or disease to be added to the list of debilitating medical conditions
that qualify for the use of cannabis.
(7) “Plant” means any cannabis plant, cutting, or clone that
has roots or that is cultivated with the intention of growing roots.
(8) “Policy” means a written statement of principles
that guides and determines present and future decisions and actions of the
licensed producer.
(9) “Practitioner”
means a person licensed in New Mexico to prescribe and administer drugs that
are subject to the Controlled Substances Act, Sections 30-31-1 et seq., NMSA 1978.
(10) “Primary
caregiver” means a
resident of New Mexico who is at least 18 years of age and who has been
designated by the qualified patient or their representative and the patient’s
practitioner as being necessary to take
responsibility for managing the well-being of a qualified patient with respect
to the medical use of cannabis pursuant to the provisions of the Lynn and Erin
Compassionate Use Act, Section 26-2B-1 et seq., NMSA 1978.
(11) “Primary caregiver
application form” means the registry identification card application
form provided by the medical cannabis program.
(12) “Private
entity” means a private,
non-profit organization that applies to become or is licensed as a producer and
distributor of cannabis, concentrates, or cannabis-derived products.
(13) “Produce” means to engage in any
activity related to the planting or cultivation of cannabis.
(14) “Proficiency testing” means testing conducted by the department or its agent to
determine the ability of a laboratory applicant or approved laboratory to
accurately identify presence, quantity, or other factors pertaining to a given
analyte.
Q. Definitions beginning
with “Q”: “Qualified patient”
means a resident of New Mexico who has been diagnosed by a practitioner as
having a debilitating medical condition and has received a registry
identification card issued pursuant to the requirements of the act or
department rules.
R. Definitions
beginning with “R”:
(1) “Recall” means to request the return of a product after the
discovery of a safety issue or product defect.
(2) “Reciprocal limit” means the quantity of cannabis and cannabis products that a
reciprocal participant can use and possess in a given year pursuant to
department rule.
(3) “Reciprocal participant” means an
individual who holds proof of authorization to participate in the medical
cannabis program of another state of the United States, the District of Columbia,
a territory or commonwealth of the United States or a New Mexico Indian nation,
tribe or pueblo.
(4) “Registry identification card” means
a document issued and owned by the department which identifies a qualified
patient authorized to engage in the use of cannabis for a debilitating medical
condition or a document issued by the department which identifies a primary caregiver authorized to engage in the intrastate possession and
administration of cannabis for the sole use of the qualified patient.
(5) “Representative”
means an individual designated as the applicant’s or petitioner’s agent,
guardian, surrogate, or other legally
appointed or authorized health care decision maker.
S. Definitions
beginning with “S”:
(1) “Secretary” means the secretary of the New Mexico department of health.
(2) “Secure
grounds” means a facility that
provides a safe environment to avoid loss or theft.
(3) “Security
alarm system” means any device or series of devices capable of
alerting law enforcement , including, but not limited to, a signal system
interconnected with a radio frequency method such as cellular, private radio
signals, or other mechanical or electronic device
used to detect or report an emergency or unauthorized intrusion.
(4) “Security policy” means
the instruction manual or pamphlet adopted or developed by the licensed
producer containing security policies, safety and security procedures, and personal safety and crime prevention techniques.
(5) “Seedling”
means a cannabis plant that has no flowers and that is less than 12 inches
in height, as measured vertically in the plant’s natural position from the
uppermost part of the root system (or from the soil line, if the plant is
planted in soil) to the tallest point of the plant.
(6) “Segregate” means to separate and
withhold from use or sale batches, lots, cannabis, usable cannabis, or
cannabis-derived products in order to first determine its suitability for use
through testing by an approved laboratory.
T. Definitions beginning
with “T”:
(1) “THC” means tetrahydrocannabinol, a cannabinoid that is the primary
psychoactive ingredient in cannabis.
(2) “THCA”
means tetrahydrocannabinolic acid, a non-psychoactive ingredient in cannabis
and an acid precursor to THC.
(3) “Technical
evidence” means scientific, clinical, medical, or other specialized testimony, or
evidence, but does not include legal argument, general comments, or statements
of policy or position concerning matters at issue in the hearing.
(4) “Telemedicine”
means the use of telecommunications and information technology to provide
clinical health care from a site apart from the site where the patient is
located, in real time or asynchronously
including the use of interactive simultaneous
audio and video or store-and-forward technology, or off-site patient
monitoring and telecommunications in order to
deliver health care services.
(5) “Testing” means testing of cannabis and cannabis derived products, consistent
with provisions of this rule.
U. Definitions beginning with “U”:
(1) “Unit” means a
quantity of usable cannabis, concentrate, or cannabis-derived product that is
used in identifying the maximum supply that a qualified patient may possess for
purposes of department rules.
(2) “Usable cannabis”
means the dried leaves and flowers of the female cannabis plant and
cannabis-derived products, including concentrates, but does not include the
seeds, stalks, or roots of the plant.
V. Definitions
beginning with “V”: [RESERVED]
W. Definitions beginning with “W”: “Wastage”
means the destruction of usable cannabis or cannabis plants.
X. Definitions
beginning with “X”: [RESERVED]
Y. Definitions
beginning with “Y”: [RESERVED]
Z. Definitions
beginning with “Z”: [RESERVED]
[7.34.4.7 NMAC - Rp, 7.34.4.7 NMAC, 6/23/2020]
7.34.4.8 PRODUCER LICENSING; GENERAL PROVISIONS:
A. The department may license two
classes of producers:
(1) A qualified patient or primary
caregiver who holds a valid personal production
license. A qualified patient or primary
caregiver who holds a valid personal production license is authorized to
possess no more than four mature female plants and a combined total of 12
seedlings and male plants, and may possess
no more than an adequate supply of usable cannabis, as specified in
department rule; provided that a qualified patient or qualified patient’s
primary caregiver may possess that qualified patient’s harvest of
cannabis. A personal production license
holder may additionally obtain usable cannabis, seeds, or plants from licensed
non-profit producers. The primary
caregiver of a qualified patient who holds a personal production license may
assist the qualified patient to produce medical cannabis at the designated
licensed location that is identified on the personal production license.
(2) A non-profit producer that
operates a facility and, at any one time, is
limited to a combined total of no greater
than 1,750 cannabis plants, not including seedlings, and an inventory of usable
cannabis and seeds that reflects current patient needs. A non-profit producer may possess any
quantity of seedlings, as defined in this rule.
A non-profit producer shall not possess a quantity of cannabis plants
that exceeds the quantities authorized by their licensure and associated
licensing fee. A licensed non-profit
producer may sell and distribute usable cannabis to a person or entity
authorized to possess and receive it. A
licensed non-profit producer may obtain plants, seeds and usable cannabis from
other licensed non-profit producers.
B. Increase
to non-profit producer plant limit: The
department may increase the cannabis plant limitation for a licensed non-profit
producer in accordance with the following:
(1) Effective
June 1, 2021, a non-profit producer may request an increase of up to 500 plants
that exceeds the total plants allowed in Paragraph (2) of Subsection A of
7.34.4.8 NMAC at the time of renewal of its licensure period. In order to be considered for approval by the
department, the non-profit producer shall demonstrate a need for the plant
count increase to meet demand for their qualified patients. The non-profit producer shall provide the
following information to the department to demonstrate the need for a plant
count increase:
(a) average
yield of usable cannabis flower and trim produced by the non-profit producer
from the past 12 months;
(b) current
reported inventory of cannabis and cannabis-derived products;
(c) percentage
of usable cannabis and cannabis-derived products that was sold to qualified
patients, primary caregivers, or to another licensed producer or manufacturer;
and
(d) any
other information requested by the department.
(2) The
department shall make a determination to approve or deny the non-profit
producer’s request to increase plant count based on the following factors:
(a) the
non-profit producer has sold at least eighty percent of its usable cannabis for
the last 12 months it has operated;
(b) the
non-profit producer’s current inventory and average yield of usable cannabis is
consistent with current averages from other licensed producers;
(c) the
number and severity of complaints and enforcement actions on the non-profit
licensed producer;
(d) the
information provided by non-profit producer is consistent with the quarterly
reports or inventory tracking information it has provided to the department
within the last 12 months;
(e) supply
and demand of medical cannabis throughout the state and in underserved
geographical regions; and
(f) the
completeness of information and data provided to the department.
(3) Effective
June 1, 2021, a non-profit producer may request an emergency increase once per
year outside of their license renewal period, of up to 500 plants that exceeds
the total plants allowed in Paragraph (2) of Subsection A of 7.34.4.8 NMAC, at
any time. The non-profit producer shall
demonstrate a need for the plant count increase to meet demand for their
qualified patients, and shall submit to the department the information
identified in Paragraph (1) of Subsection B of 7.34.4.8 NMAC. The department shall only approve the request
if the non-profit producer can demonstrate by clear and convincing evidence
that it is not able to meet qualified patient demand for usable cannabis or
cannabis-derived products with its current plant count or by obtaining usable
cannabis or cannabis products from another licensed producer. The non-profit producer shall provide
objective data about the current supply in the medical cannabis market to
demonstrate these factors. The
department shall also consider the same factors in Subsection B when approving
or denying this request.
(4) Any increase
in plant count approved under this section shall be voided in the event of a
transfer of the majority of ownership for a licensed producer, at which time
the plant limit for the license shall revert to the limit allowed in Paragraph
(2) of Subsection A above.
(5) The
department is not required to approve a request for an increase to a non-profit
producer’s plant limit and retains sole discretion to grant or deny the
request.
C. Limitation on distribution: A
non-profit producer shall not knowingly sell or otherwise distribute usable
cannabis to any person or entity that is not authorized to possess and receive
the usable cannabis pursuant to department rules.
D. Processing
of production applications:
(1) The issuance of an application is
in no way a guarantee that the completed
application will be accepted or that a license will be granted. Information provided by the applicant and
used by the licensing authority for the licensing process shall be accurate and
truthful. Any applicant that fails to
participate in good faith or that falsifies information presented in the
licensing process shall have its application denied by the department.
(2) The number of licenses issued by the department to
non-profit private entities, and the determination of which non-profit entities shall be licensed, shall be determined at
the discretion of the secretary, which determination shall constitute the final
administrative decision of the department.
(3) An applicant whose
application for licensure is not approved shall not be entitled to further
administrative review.
E. Factors
considered: The secretary shall consider the overall
health needs of qualified patients and the safety of the public in determining the number of licenses to be issued to non-profit private
entities and shall further consider:
(1) the sufficiency of the overall supply available to qualified
patients statewide;
(2) the service location of the applicant;
(3) the applicant’s production plan, including but not limited
to the applicant’s plan for the growth, cultivation, and harvesting of medical
cannabis;
(4) the
applicant’s sales and distribution plan, including but not limited to the
applicant’s plan for sale of medical cannabis, plan for delivery (if any) to
qualified patients, and the forms of usable cannabis and cannabis-derived
products to be sold or distributed;
(5) the applicant’s skill and knowledge of horticulture and cannabis production technology, as well
as the applicant’s knowledge of current good manufacturing practice in
manufacturing, packaging, labeling, or holding operations for dietary supplements;
environmental protection agency agricultural worker protection standards; and
New Mexico department of agriculture (NMDA) pesticide registration, licensing
and use requirements to ensure a safe product and environment;
(6) the applicant’s plan for the manufacture or distribution of
cannabis derived products, including but not limited to edible products;
(7) the
security plan proposed, including location, security devices employed, and
staffing;
(8) the applicant’s quality assurance
plan, including but not limited to the applicant’s
plan to ensure purity, consistency of dose,
as well as the applicant’s plan for routine
testing by a department approved laboratory;
(9) the experience and expertise of the non-profit board
members;
(10) the
financial resources available to the applicant for licensure and operations;
(11) the
facilities available to the applicant for production, distribution, storage,
and other purposes, and the applicant’s ownership of the property, buildings,
or other facilities identified in the production and distribution plan, as
applicable; and
(12) other relevant factors.
F. Production and distribution
of medical cannabis by a licensed non-profit producer; use of couriers: Production
and distribution of medical cannabis by a licensed non-profit producer to a
qualified patient or primary caregiver shall take place at locations described
in the non-profit producer’s production and distribution plan approved by the department, and shall not take place at locations that are
within 300 feet of any school, church, or daycare center that existed
within the 300-foot area before the producer became licensed to operate at the
location; provided that this distance requirement
shall not apply to distribution at the home of the qualified patient or
primary caregiver. A licensed non-profit producer may,
consistent with this rule, and with the consent of a purchasing qualified
patient or primary caregiver, utilize an approved courier to transport usable
cannabis to a qualified patient or primary caregiver, and may for this purpose
share with an approved courier the contact information of the purchasing
qualified patient or primary caregiver. A licensed non-profit producer may, consistent with this
rule, also utilize an approved courier to transport usable cannabis to another
non-profit producer, to an approved laboratory, and to an approved
manufacturer. A licensed non-profit
producer shall not identify any person as an intended recipient of usable
cannabis who is not a qualified patient, a primary caregiver, an approved
courier, an approved manufacturer, or an approved laboratory.
G. Verification of application
information: The department may verify information
contained in each application and accompanying
documentation by:
(1) contacting the applicant by telephone, mail, or electronic
mail;
(2) conducting an on-site visit;
(3) requiring a face-to-face meeting
and the production of additional identification
materials if proof of identity is uncertain; and
(4) requiring additional relevant information as the department
deems necessary.
H. Cooperation with the department: Upon submitting an application, an applicant shall fully cooperate with the department and
shall timely respond to requests for information or documentation. Failure to cooperate with a request of the
department may result in the application being denied or otherwise declared
incomplete.
I. Criminal history screening
requirements: All persons associated with a licensed
non-profit producer or non-profit producer-applicant, manufacturer or
manufacturer-applicant, approved laboratory or laboratory applicant, and
approved courier or courier-applicant, shall consent to and undergo a
nationwide and department of public safety (DPS) statewide criminal history
screening background check. This
includes board members, persons having direct or indirect authority over
management or policies, employees, contractors, and agents. Background check documentation shall be
submitted annually for approval to the department with the applicant’s renewal
materials and prior to an individual assuming any duties or responsibilities
for a non-profit producer, manufacturer, laboratory, or courier. Background check documentation shall be received
by the medical cannabis program, and the individual shall be approved by the
program, before the individual begins to provide any work or services to the
producer, manufacturer, laboratory, or courier.
(1) Criminal history screening fees: All applicable fees associated with the nationwide
and DPS statewide criminal history screening
background checks shall be paid by the non-profit producer, manufacturer,
laboratory, courier, or applicant.
(2) Disqualifying
convictions:
Individuals convicted of a felony violation of Section 30-31-20
(trafficking of a controlled substance); 30-31-21 (distributing a controlled
substance to a minor); 30-31-22 NMSA 1978 (distributing a controlled
substance); or a violation of any equivalent federal
statute or equivalent statute from any other jurisdiction, shall be prohibited
from participating or being associated with either a non-profit producer
licensed under this rule, an approved laboratory, an approved manufacturer, or
an approved courier.
If an individual has been convicted of a felony violation of the NM Controlled Substances Act other than Sections 30-31-20 through 30-31-22 NMSA 1978, or
has been convicted of any equivalent federal statute or equivalent statute from
any other jurisdiction, and the final completion of the entirety of the associated sentence of such conviction has been less than five years
from the date of the individual’s anticipated association with the production
facility, then the individual shall be prohibited from serving on the board of
a licensed non-profit producer, or working for the licensed producer, or
approved entity.
An individual who is disqualified shall be
notified of his or her disqualification. If an individual has been convicted of more
than one felony violation of the above-cited sections of the NM Controlled
Substances Act or an equivalent federal statute or equivalent statute from any other jurisdiction, the individual shall be notified that he or she
is permanently prohibited from participating or being associated with a
licensed non-profit producer, approved manufacturer, approved laboratory, or
approved courier.
Any violation of this subsection shall result in the immediate revocation of any privilege granted under this rule and the act.
J. Board membership requirements for
private entities: The board of directors for a private
non-profit applicant or licensee shall include at a minimum five voting
members, including one medical provider limited to a physician (MD
or DO), a registered nurse, nurse practitioner, licensed practical nurse, or
physician assistant, and three patients currently qualified under the Lynn and
Erin Compassionate Use Act.
(1) for purposes of board membership, a single individual may
not qualify as both the patient and as the medical provider;
(2) members of the board of directors
for a non-profit producer shall be residents of New Mexico; and
(3) no member of a non-profit producer’s board of directors may at any
given time serve on more than one single board of directors for licensed
non-profit producers, or be employed by another non-profit producer.
K. Limitation
on number of production facilities:
A licensed non-profit producer shall conduct its production operations
at a single, physical location approved by the department. An additional production facility or
facilities may be allowed at the department’s discretion.
L. Limitation
on sales within 90 consecutive calendar days: A licensed
non-profit producer shall not sell or distribute usable cannabis to a qualified
patient or primary caregiver in a total quantity that exceeds 230 units, as
described in department rules concerning patient registry identification cards,
within any 90-day period, unless the qualified patient or primary caregiver
presents proof of a valid medical exception granted by the department.
M. Destruction of usable cannabis and cannabis
plants: A licensed non-profit
producer shall document the destruction of any usable cannabis or cannabis
plants using a video recording, and shall retain the video recording of the
destruction for no less than 120 days. A
licensed non-profit producer shall make the video recording of the destruction
available for the department’s inspection or copying upon the department’s
request.
N. Maximum water content in dried usable
cannabis: A licensed non-profit
producer shall not sell usable cannabis, other than a cannabis derived product,
that contains fifteen percent or greater
water content by weight. A licensed
non-profit producer may be subject to testing to ensure compliance, consistent
with the provisions of this rule.
O. Non-profit producer policies and
procedures: The
non-profit producer shall develop, implement, and maintain on the premises
policies and procedures relating to the medical cannabis program, which shall
at a minimum include the following:
(1) distribution criteria for qualified patients or primary caregivers appropriate for cannabis
services, to include clear, legible photocopies of the registry identification
card and New Mexico photo identification card of every qualified patient or
primary caregiver served by the private entity;
(2) testing
criteria and procedures, which shall be consistent with the testing
requirements of this rule;
(3) alcohol and drug-free work place
policies and procedures;
(4) an
attestation that no firearms will be permitted on any premises used for
production or distribution by the non-profit entity;
(5) employee policies and procedures
to address the following requirements:
(a) job descriptions or employment contracts developed for every employee that identify duties, authority, responsibilities,
qualifications, and supervision; and
(b) training materials concerning adherence to state and federal
confidentiality laws.
(6) personnel records for each employee that include an application for employment and
a record of any disciplinary action taken;
(7) on-site training curricula, or contracts with outside
resources capable of meeting employee training needs, to include, at a minimum, the following topics:
(a) professional conduct, ethics, and patient confidentiality;
and
(b) informational developments in the field of medical use
of cannabis.
(8) employee safety and security
training materials provided to each employee 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.
(9) a general written security
policy, to address at a minimum:
(a) safety and security procedures;
(b) personal safety; and
(c) crime prevention techniques.
(10) training documentation prepared for each employee and 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;
(11) a written policy regarding
the right of the private entity to refuse service;
(12) a
confidentiality policy to ensure that identifying information of qualified
patients is not disclosed or disseminated without authorization from the
patient, except as otherwise required by the department;
(13) an
attestation that the nonprofit producer will prohibit its
employees and contractors from being under the influence of drugs or alcohol in
the workplace; and
(14) such
other policies or procedures as the department may require.
P. Retention of training documentation: A non-profit producer shall maintain
documentation of an employee’s training for a period of at least six months
after termination of an employee’s employment.
Q. Licensure periods:
(1) Licensure period for non-profit
producers:
The licensure period of a licensed non-profit producer shall be from
August 1st (or the date of approval of the licensure application, if later)
through July 31st of a given year.
Exception; transition to revised 2019 rules: The licensure period for a licensed
non-profit producer that would otherwise end on August 1, 2019 shall instead
continue until September 30, 2019.
(2) Licensure period for qualified
patient producers: A qualified patient’s personal production
license shall expire one year after the issuance of the
personal production license, or at the end of the person’s enrollment in the NM
medical cannabis program, whichever occurs first.
(3) Identification
cards: An employee of a licensed non-profit producer 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. Licenses and
identification cards issued by the department are the property of the department
and shall be returned to the department upon a producer’s withdrawal from the
program, upon termination of a card holder’s employment with a licensed
non-profit producer, or upon suspension or revocation.
R. Amended
license:
(1) Submittal of application for amended
license: A licensed producer 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 a qualified patient who also holds a
personal production license;
(b) change of location of a non-profit producer’s
production or distribution facilities, change of
directors, change of ownership of production or distribution facilities, producer
name, capacity or any physical modification or addition to the facility; and
(c) substantial change to a producer’s production plan or
distribution plan, including any change to the type(s) of products produced or distributed, the producer’s manufacturing plan (as
applicable), the producer’s method(s) of distribution, and 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 licensed
producer 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 licensed producer will be required to recommence the
application in order to resume the application process.
S. Application
for renewal of an annual production license:
(1) Deadline for private entities. Each licensed non-profit producer shall apply
for renewal of its annual license no later than August 1st of
each year by submitting a renewal application to the department. The department shall
provide the renewal application requirements no later than June 1st of each
year.
(2) Deadline for personal production
license holders: A patient who holds personal production
licensure shall apply for renewal of their annual license no later than 30 days
prior to the expiration of the license by submitting a renewal application to
the department.
(3) General submission requirements for
qualified patients: Qualified
patients applying for personal production licensure shall submit:
(a) an application for issuance or
renewal of a personal production license; and
(b) a non-refundable thirty dollar ($30) application fee, except that the fee may be waived upon a showing
that the income of the qualified patient is equal to or lesser than two hundred
percent of the federal poverty guidelines established by the U.S. department of
health and human services. A lost or
stolen identification card shall be reported as soon as practicable to the
medical cannabis program.
(4) General
submission requirements for private entities: Private entities shall submit:
(a) an application for renewal of
license; and
(b) applicable non-refundable licensure renewal fees.
T. Non-transferable registration of
license:
(1) A
license shall not be transferred by assignment or otherwise to other persons or
locations. Unless the licensed producer
applies for and receives an amended license, the
license shall be void and returned to the department when any one of the
following situations occurs:
(a) ownership of the facility changes;
(b) location change;
(c) change in licensed producer;
(d) the discontinuance of operation;
or
(e) the removal of all medical
cannabis from the facility by lawful state authority.
(2) Transactions, which do not constitute a change of ownership,
include the following:
(a) when applicable, changes in the
membership of a corporate board of directors or board of trustees; and
(b) two or more corporations merge and the originally licensed
corporation survives.
U. Automatic expiration of license;
closure of nonprofit producer operations: A license shall expire at 11:59
p.m. on the day indicated on the license as the expiration date, unless the
license was renewed at an earlier date, suspended, or revoked.
V. Display of license: The licensed producer shall maintain the
license safely at the production location(s) and dispensary location(s) and
shall be able to produce the license immediately upon request by the department
or law enforcement.
W. Fees applicable to applicants and
licensees:
(1) Non-profit
producer application fee: A non-profit producer shall submit with its
initial application an application fee of ten thousand dollars ($10,000). If the application is denied, the department
shall issue a refund of nine thousand dollars ($9,000) to the applicant.
(2) Non-profit producer license fee: A non-profit producer that is licensed shall
submit to the medical cannabis program a non-refundable licensure fee before
beginning operations, no earlier than July 1st of each renewal year and no
later than August 1st of each renewal year, of: $40,000 for the first 500
cannabis plants to be possessed by the non-profit producer; $5,000 for each
additional increment of 50 cannabis plants above 500 and up to a collective
total of 1,000 cannabis plants; and $6,000 for each additional increment of 50
cannabis plants above 1,000.
(3) Exception;
transition to revised LNPP fees, plant limits: A fee that is paid by a non-profit producer
in the year 2019 shall be tendered to the department no earlier than September
23, 2019 and no later than October 4, 2019.
(4) Exception; newly licensed LNPPs: The license fee to be paid by a non-profit
producer that obtains initial licensure after the enactment of this revised
rule shall be pro-rated based on the time remaining in the licensure period.
(5) Qualified patient personal production
fees: A qualified patient shall submit with
each initial application and renewal application for personal production
licensure a fee of thirty dollars ($30), except
that the fee may be waived upon a showing that the income of the qualified
patient is equal to or lesser than two hundred percent of the federal poverty
guidelines established by the U.S. department of health and human services; and.
(6) Replacement
license fee: A fifty dollar ($50)
payment is required for replacement of an identification card for an employee
of a licensed non-profit producer, and for replacement of a personal production
license card.
(7) Payment: Fees shall be
paid by
check, money order, or any other form of payment approved by the medical
cannabis program director or designee, and shall be made payable to the medical
cannabis program of the department.
X. Geographic requirements for initial
licenses: The department may require
that a non-profit producer operate dispensaries in geographical locations of
the state that are specified by the department as a precondition of initial
licensure.
Y. Inventory and sales equipment: The department may
require a licensed non-profit producer 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.
Z. Reporting of theft to department: A
non-profit producer shall submit to the department notification of any theft,
robbery, break-in, or security breach that occurs on the producer’s premises,
no later than 10 calendar days after the producer 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.
AA. Closure of applications period: The department may close the applications
period during which applications for non-profit producer licenses will be
accepted and reviewed.
[7.34.4.8 NMAC - Rp, 7.34.4.8 NMAC, 6/23/2020]
7.34.4.9 NON-PROFIT PRODUCERS; MINIMUM STANDARDS FOR
PRODUCTION OF CANNABIS: A non-profit producer shall
comply with the following minimum requirements for the production of cannabis:
A. General requirements: A licensed non-profit producer shall ensure
the following:
(1) that all production activities are
done on premises that are in compliance with state and local laws, including
but not limited to zoning, occupancy, licensing, and building codes;
(2) that
all equipment, implements, and fixtures that are used for the production of
cannabis shall be used exclusively for the production of cannabis;
(3) that
no cannabis plants other than those grown pursuant to the non-profit producer’s
production license from the department are grown on the licensed property of
the non-profit producer, including but not limited to hemp plants;
(4) that
production is conducted in a manner that does not allow cross-contamination
from chemical or biological hazards;
(5) that
production 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
producer became licensed to operate at the location;
(6) 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
cannabis, shall be excluded from any operations which may be anticipated to
result in such contamination until the condition is corrected;
(7) 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;
(8) that
all persons involved in preparing or handling medical cannabis 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 work, 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; and
(d) complying
with the other requirements of this section;
(9) 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;
(10) 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 cannabis is exposed;
(11) that
all floors (other than earthen floors), walls, and ceilings that are located
within a permanent structure are constructed in such a manner that they are
washable, wipeable, and non-absorbent, and can be kept clean, and kept in good
repair;
(12) that
walls and ceilings remain free of water damage, and that fiberglass and other
insulation material not be exposed;
(13) that there is adequate safety-type
lighting in all areas where cannabis is processed or stored, and where
equipment or utensils are cleaned;
(14) that
the non-profit producer 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;
(15) that
building, fixtures, and other physical facilities where cannabis is produced
are maintained in a sanitary condition;
(16) that
all contact surfaces, including utensils and equipment used for preparation of cannabis,
are cleaned and sanitized as frequently as necessary to protect against
contamination;
(17) that
all equipment and utensils used for preparation of cannabis are designed and of
such material and workmanship as to be adequately cleanable, and are properly
maintained;
(18) that
only environmental protection agency (EPA) registered sanitizing agents are
used in production operations and that they are used in accordance with labeled
instructions;
(19) 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, and that otherwise satisfies the
requirements of this rule;
(20) 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 production
facility’s needs;
(21) 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;
(22) that
there are no cross-connections between the potable and waste water lines;
(23) that
the non-profit producer provide its employees with adequate, readily
accessible, on-site toilet facilities that are maintained in a sanitary
condition and good repair;
(24) that
all operations in the receipt, inspection, transport, segregation, preparation,
manufacture, packaging, and storage of usable cannabis are conducted in
accordance with adequate security and sanitation principles;
(25) that
usable cannabis that can support the rapid growth of undesirable microorganisms
are stored and transported in a manner that prevents the growth of these
microorganisms;
(26) that
storage and transportation of usable cannabis is accomplished under conditions
that will maintain security and protect the usable cannabis against physical,
chemical, and microbial contamination as well as against deterioration of the usable
cannabis and the container;
(27) 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;
(28) that
all containers used for storage or transport of usable cannabis are washable,
wipeable, and nonabsorbent;
(29) that all weighting or measuring devices
that are used in the production or distribution 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;
(30) that the non-profit producer will
prohibit its employees and contractors from being under the influence of drugs
or alcohol in the workplace; and
(31) that hemp, hemp extract, and hemp
derived products, other than hemp paper and hemp seed oil, are not combined in
any manner with usable cannabis intended to be sold or otherwise distributed by
the non-profit producer.
[7.34.4.9 NMAC - Rp, 7.34.4.9 NMAC, 6/23/2020]
7.34.4.10 TESTING OF USABLE CANNABIS:
All dried usable cannabis produced
by a non-profit producer that is not converted into a concentrated cannabis
derived product, and all concentrated cannabis derived products manufactured by
a non-profit producer or manufacturer, shall be sampled for testing purposes by
the licensed non-profit producer or manufacturer, and those samples shall be
tested by an approved laboratory consistent
with the requirements of this rule and found to have passed all tests required
by this rule, prior to the sale, distribution, or other use of the product. Each batch of dried usable cannabis, other
than cannabis that will be converted into a concentrated cannabis derived
product, shall be segregated and sampled by
the non-profit producer that produced the batch, and the non-profit producer
shall ensure that each sample is tested by an approved laboratory in accordance
with the testing requirements of this rule and determined to have passed the
following individual testing requirements, before dried usable cannabis from
that batch is made available for sale or distribution, and before the dried
usable cannabis or any substance derived therefrom is incorporated into a
cannabis derived product. Each batch of concentrated
cannabis derived product shall be segregated and sampled by the manufacturer or
non-profit producer that produced the batch, and the manufacturer or non-profit
producer (as applicable) shall ensure that each sample is tested by an approved
laboratory in accordance with the testing requirements of this rule, and
determined by the manufacturer or non-profit producer (as applicable) to have
passed the following individual testing requirements, before cannabis derived
product from that batch is made available for sale or distribution.
A. Exception; staggered implementation: The department may within its discretion waive
testing requirements of this section, in whole or in part, based on
considerations such as the ability of currently approved laboratories to
process all testing samples, or in order to allow additional time for
laboratories to implement revised testing standards.
B. Exception for previously tested cannabis: Except as otherwise provided in this rule, a
non-profit producer or manufacturer shall not be required to sample and test dried
usable cannabis or a concentrated cannabis-derived product if the batch was
previously sampled and the sample was tested by another non-profit producer or
manufacturer in accordance with this rule and determined to have passed the
testing requirements of this rule.
C. Individual
testing requirements:
(1) Microbiological
test: A non-profit producer shall sample and test
dried usable cannabis, and a manufacturer or non-profit producer (as
applicable) shall sample and test concentrated cannabis derived products, for
microbiological contaminants, using an approved laboratory prior to sale, distribution, or other use. A sample may be deemed to have passed the
microbiological test if the sample contains less than each action level set
forth in Table 1, Microbiological Testing
Requirements, below.
|
Table 1. Microbiological Testing
Requirements |
|||
|
Final Product |
Test Parameter |
Action Level |
Test Units |
|
Chopped or Powdered Botanicals (Dried Usable
Cannabis Not Extracted) |
Total Aerobic Microbial Count |
>100000 |
cfu/g or cfu/mL |
|
Total Combined Yeast & Mold Count |
>1000 |
cfu/g or cfu/mL |
|
|
Bile-tolerant Gram-negative Bacteria |
>1000 |
cfu/g or cfu/mL |
|
|
Absence of Salmonella spp. & E. coli |
Absent |
In 10 grams cfu/g or cfu/mL |
|
|
Total Coliforms Count |
>1000 |
cfu/g or cfu/mL |
|
|
Powdered Botanical Extracts (Extracted or
Processed Cannabis Product i.e. hash, bubble hash, rosin, kief) |
Total Aerobic Microbial Count |
>10000 |
cfu/g or cfu/mL |
|
Total Combined Yeast & Mold Count |
>1000 |
cfu/g or cfu/mL |
|
|
Bile-tolerant Gram-negative Bacteria |
>1000 |
cfu/g or cfu/mL |
|
|
Absence of Salmonella spp. & E. coli |
Absent |
In 10 grams cfu/g or cfu/mL |
|
|
Total Coliforms Count |
>1000 |
cfu/g or cfu/mL |
|
|
Tinctures (Solutions of Cannabis in Alcohol) |
Total Aerobic Microbial Count |
>10000 |
cfu/g or cfu/mL |
|
Total Combined Yeast & Mold Count |
>1000 |
cfu/g or cfu/mL |
|
|
Infusions (solutions of cannabis in water) |
Total Aerobic Microbial Count |
>100 |
cfu/g or cfu/mL |
|
Total Combined Yeast & Mold Count |
>10 |
cfu/g or cfu/mL |
|
|
Decoctions (Solutions of Cannabis derived by
boiling in water for at least 15 minutes) |
Total Aerobic Microbial Count |
>100 |
cfu/g or cfu/mL |
|
Total Combined Yeast & Mold Count |
>10 |
cfu/g or cfu/mL |
|
|
Fluid extracts (An alcoholic liquid extract
made by percolation of Cannabis so that 1 mL of the fluidextract represents 1
g of the Cannabis) |
Total Aerobic Microbial Count |
>10000 |
cfu/g or cfu/mL |
|
Total Combined Yeast & Mold Count |
>1000 |
cfu/g or cfu/mL |
|
|
Nutritional Supplements with Botanicals |
Total Aerobic Microbial Count |
>100000 |
cfu/g or cfu/mL |
|
Total Combined Yeast & Mold Count |
>1000 |
cfu/g or cfu/mL |
|
|
Absence of Salmonella spp. & E. coli |
Absent |
In 10 grams cfu/g or cfu/mL |
|
|
Botanicals to be treated with boiling water
before use (Dried Cannabis to which boiling water is added immediately prior
to consumption) |
Total Aerobic Microbial Count |
>100000 |
cfu/g or cfu/mL |
|
Total Combined Yeast & Mold Count |
>1000 |
cfu/g or cfu/mL |
|
|
Absence of E. coli |
Absent |
In 10 grams cfu/g or cfu/mL |
|
|
Nutritional products with other highly
refined ingredients (Edibles) |
Total Aerobic Microbial Count |
>1000 |
cfu/g or cfu/mL |
|
Total Combined Yeast & Mold Count |
>100 |
cfu/g or cfu/mL |
|
|
Absence of E. coli |
Absent |
In 10 grams cfu/g or cfu/mL |
|
|
Quantitative analysis results shall be
rounded off to the first two significant digits. |
|||
|
E. coli and Salmonella results shall be
reported as Present or Absent. |
|||
(2) Mycotoxin
test: A non-profit producer shall
sample and test dried usable cannabis, and a manufacturer or non-profit
producer (as applicable) shall sample and test concentrated cannabis derived
products, for mycotoxins, using an approved laboratory prior to sale, distribution, or other use. A sample may be deemed to have passed the
mycotoxin test if the total quantity of aflatoxin B1, B2, G1, and G2 and ochratoxin A is collectively
less than 20 µg/kg
(parts per billion) of the sample. The
mycotoxin test shall be conducted in accordance with the testing requirements
at Table 2, Mycotoxins Testing Requirements.
|
Table 2. Mycotoxins Testing Requirements |
|||||
|
Targeted Mycotoxins |
Chemical Name |
Abbreviation |
CAS Number |
Method Reporting Level (µg/kg)* |
Action Level (µg/kg)* |
|
Aflatoxins |
Aflatoxin B1 |
AFB1 |
1162-65-8 |
1.0 |
Combined concentration
of five mycotoxin components: 20 |
|
Aflatoxin B2 |
AFB2 |
7220-81-7 |
1.0 |
||
|
Aflatoxin G1 |
AFG1 |
1165-39-5 |
1.0 |
||
|
Aflatoxin G2 |
AFG2 |
7241-98-7 |
1.0 |
||
|
Ochratoxin |
Ochratoxin A |
OTA |
303-47-9 |
1.0 |
|
|
Mycotoxins
Reporting Requirements for DOH Medical Cannabis Program Use two significant digits when reporting a
total mycotoxins result. Non-detects are reported as less than the
Method Reporting Level. Example:
"Total Mycotoxins < 1 µg/kg" *Micrograms of mycotoxin per kilogram (µg/kg)
of sample is equivalent to parts per billion (ppb). |
|||||
(3) Residual
solvent test: A manufacturer or non-profit producer (as
applicable) shall sample and test all concentrated cannabis derived products
that are manufactured using solvent extraction methods for the presence of
solvent residue, using an approved laboratory prior
to sale, distribution, or other use. A sample may be deemed to have passed the residual solvent
test if the sample contains less than each action level set forth in Table 3, Residual Solvent Testing Requirements. The residual solvent test shall be conducted in accordance with
the testing requirements at Table 3.
|
Table 3. Residual Solvent Testing
Requirements |
|||||
|
Targeted Compounds |
Common Chemical Name |
IUPAC Name |
CAS Number |
Method Reporting Level (µg/g) or (ppm)* |
Action Level (µg/g) or (ppm)* |
|
Propane |
propane |
propane |
74-98-6 |
100 |
500 |
|
Butanes |
n-butane |
butane |
106-97-8 |
100 |
500 |
|
isobutane |
2-methylpropane |
75-28-5 |
100 |
500 |
|
|
Pentane |
n-pentane |
pentane |
109-66-0 |
100 |
500 |
|
Hexane |
n-hexane |
hexane |
110-54-3 |
25 |
50 |
|
Cyclohexane |
cyclohexane |
cyclohexane |
110-82-7 |
100 |
500 |
|
Benzene |
benzene |
benzene |
71-43-2 |
2.0 |
2.0 |
|
Toluene |
toluene |
methylbenzene |
108-88-3 |
100 |
200 |
|
Heptane |
n-heptane |
heptane |
142-82-5 |
100 |
500 |
|
Ethylbenzene |
ethylbenzene |
ethylbenzene |
100-41-4 |
100 |
Combined concentration of all four compounds: 400 |
|
and Xylenes |
ortho-xylene |
1,2-dimethylbenzene |
95-47-6 |
100 |
|
|
meta-xylene |
1,3-dimethylbenzene |
108-38-3 |
200 |
||
|
para-xylene |
1,4-dimethylbenzene |
106-42-3 |
|||
|
Methyl Alcohol |
methyl alcohol |
methanol |
67-56-1 |
100 |
1000 |
|
Isopropyl Alcohol |
isopropanol |
2-propanol |
67-63-0 |
200 |
1000 |
|
Methylene Chloride |
methylene chloride |
dichloromethane |
75-09-2 |
50 |
100 |
|
Acetone |
acetone |
2-propanone |
67-64-1 |
200 |
1000 |
|
Residual
Solvents Reporting Requirements for DOH Medical Cannabis Program Use two significant digits when reporting residual solvent results. Non-detects are reported as less than the
Method Reporting Level for each residual solvent. Example: "Benzene < 2.0 µg/g" Note: The isomers meta-xylene and
para-xylene cannot be separated chromatographically, so they are reported as
a pair. |
|||||
|
*Micrograms solvent per gram of sample (µg/g)
is equivalent to parts per million (ppm). |
|||||
(4) Potency test: A non-profit producer shall sample and test
all dried usable cannabis, and a non-profit producer or manufacturer (as
applicable) shall sample and test all concentrated cannabis derived products,
for quantity of tetrahydrocannabinol (THC, tetrahydrocannabinolic acid (THCA), cannabidiol
(CBD), cannabidiolic acid (CBDA), and also for THC potency and CBD potency,
using an approved laboratory prior to sale, distribution, or other use. A non-profit producer may, at the producer’s
option, also test for quantity of cannabinol (CBN), cannabigerolic acid (CBGA),
cannabigerol (CBG), cannabichromene (CBC), tetrahydrocannabivarin (THCV), and
cannabidivarin (CBDV). The potency test
shall be conducted in accordance with the testing requirements at Table 4,
Potency Testing Requirements.
|
Table 4. Potency Testing
Requirements |
||||
|
Cannabinoid |
Abbreviation |
CAS Number |
Reporting Units* |
Comments |
|
Tetrahydrocannabinolic Acid |
THCA |
23978-85-0 |
mg/g and % (Percent) |
analysis required by rule |
|
Tetrahydrocannabinol |
THC |
1972-08-3 |
mg/g and % (Percent) |
analysis required by rule |
|
Cannabidiolic Acid |
CBDA |
1244-58-2 |
mg/g and % (Percent) |
analysis required by rule |
|
Cannabidiol |
CBD |
13956-29-1 |
mg/g and % (Percent) |
analysis required by rule |
|
THC Potency |
THC Potency = Percent THCA x 0.877
+ Percent THC |
mg/g and % (Percent) |
reporting required by the rule and
calculation listed |
|
|
CBD Potency |
CBD Potency = Percent CBDA x 0.877
+ Percent CBD |
mg/g and % (Percent) |
reporting required by the rule and
calculation listed |
|
|
Cannabinol |
CBN |
521-35-7 |
mg/g and % (Percent) |
analysis optional, recommended for
strain characterization |
|
Cannabigerolic Acid |
CBGA |
25555-57-1 |
mg/g and % (Percent) |
analysis optional, recommended for
strain characterization |
|
Cannabigerol |
CBG |
25654-31-3 |
mg/g and % (Percent) |
analysis optional, recommended for
strain characterization |
|
Cannabichromene |
CBC |
20675-51-8 |
mg/g and % (Percent) |
analysis optional, recommended for
strain characterization |
|
Tetrahydrocannabivarin |
THCV |
31262-37-0 |
mg/g and % (Percent) |
analysis optional, recommended for
strain characterization |
|
Cannabidivarin |
CBDV |
24274-48-4 |
mg/g and % (Percent) |
analysis optional, recommended for
strain characterization |
|
*Milligrams per gram (mg/g) of
sample; this unit can be also expressed in percent composition of the sample. |
||||
A cannabis derived product shall be homogenous
in composition with respect to THC potency.
A product shall be deemed non-homogenous if ten percent of the infused
portion of the product contains more than twenty percent of the total THC
contained in the product. In the event
that a cannabis derived product does not meet this requirement, the batch shall
be wasted in accordance with the provisions of this rule.
(5) Heavy metal test: A non-profit producer shall sample and test
all dried usable cannabis, and a non-profit producer or manufacturer (as
applicable) shall sample and test all concentrated cannabis derived products,
for heavy metals, using
an approved laboratory, prior to sale, distribution, or
other use. A sample may be
deemed to have passed the heavy metals test if the sample contains less than
each action level set forth in Table 5, Heavy Metal Testing Requirements. The heavy metals test shall be conducted in
accordance with the testing requirements at Table 5.
|
Table 5. Heavy Metal Testing
Requirements |
|||||
|
Heavy Metals |
Elemental Symbol |
IUPAC Name |
CAS Number |
Action Level (µg/g) or (ppm)* |
Method Reporting Level (µg/g) or (ppm)* |
|
Arsenic |
As |
arsenic |
7440-38-2 |
2.0 |
0.2 |
|
Cadmium |
Cd |
cadmium |
7440-43-9 |
0.8 |
0.2 |
|
Lead |
Pb |
lead |
7439-92-1 |
1.2 |
0.2 |
|
Mercury |
Hg |
mercury |
7439-97-6 |
0.4 |
0.1 |
|
*Micrograms
per gram (µg/g) of sample is equivalent to
parts per million (ppm). |
|||||
(6) Pesticide test: A non-profit producer
shall sample and test all dried usable cannabis, and a non-profit producer or
manufacturer (as applicable) shall sample and test all concentrated cannabis
derived products, for pesticide content using an approved laboratory prior to
sale, distribution, or other use. A
sample may be deemed to have passed the pesticide test if the sample contains
less than each action level set forth in Table 6, Pesticide Testing
Requirements. The pesticide test shall
be conducted in accordance with the testing requirements at Table 6.
|
Table 6. Pesticide Testing
Requirements |
||||
|
Targeted Pesticide |
Common Chemical Name |
CAS Number |
Action Level (µg/kg) |
Method Reporting Level (µg/kg) |
|
Abamectin |
avermectin
B1a & avermectin B1b |
71751-41-2 |
500 |
100 |
|
Azoxystrobin |
azoxystrobin |
131860-33-8 |
200 |
100 |
|
Bifenazate |
bifenazate |
149877-41-8 |
200 |
100 |
|
Etoxazole |
etoxazole |
153233-91-1 |
200 |
100 |
|
Imazalil |
chloramizole |
35554-44-0 |
200 |
100 |
|
Imidacloprid |
imidacloprid |
138261-41-3 |
400 |
100 |
|
Malathion |
malathion |
121-75-5 |
200 |
100 |
|
Myclobutanil |
myclobutanil |
88671-89-0 |
200 |
100 |
|
Permethrins |
cis-permethrin & trans-permethrin |
52645-53-1 |
200 |
100 |
|
Spinosad |
spinosyn
A & spinosyn D |
168316-95-8 |
200 |
100 |
|
Spiromesifen |
spiromesifen |
283594-90-1 |
200 |
100 |
|
Spirotetramat |
spirotetramat |
203313-25-1 |
200 |
100 |
|
Tebuconazole |
tebuconazole |
80443-41-0 |
400 |
100 |
|
*Micrograms of pesticide per
kilogram (µg/kg)
of sample is equivalent to parts per billion (ppb). |
||||
(7) Moisture
content test: A non-profit producer
shall sample and test all dried usable cannabis for moisture content using an
approved laboratory prior to sale, distribution, or other use.
(8) Random testing of finished cannabis
derived products:
A non-profit producer or manufacturer that
manufactures a cannabis derived product shall establish a schedule for, and
shall conduct, random sampling and testing of finished, non-concentrated
cannabis derived products, including but not limited to edible cannabis derived
products, as follows:
(a) The
non-profit producer or manufacturer shall randomly select and sample at and at
least one percent of all non-concentrated cannabis derived product batches
manufactured every week (and no less than one batch);
(b) The non-profit producer or
manufacturer shall apply the sampling and testing standards that otherwise
apply under this rule to dried cannabis and concentrated cannabis derived
products; and
(c) In the event that a sample fails any
of the required tests, the batch shall not be sold, distributed, or otherwise
used, unless remediated in accordance with the remediation standards of this
rule.
(9) Additional testing: The department may require additional testing
of cannabis and cannabis derived products by non-profit producers and
manufacturers, as it deems appropriate.
D. Release of batch after testing: A licensed non-profit producer or manufacturer
may release an entire batch of dried cannabis or concentrated cannabis derived
product for immediate manufacture, sale, or other use, provided that the sample
taken from the batch passes the tests required in this section.
E. Procedures for testing: A licensed
non-profit producer and a manufacturer shall ensure that the following testing
procedures are followed:
(1) sampling
and segregation: a licensed
non-profit producer or manufacturer shall remove a sample of no less than the
quantities of cannabis or cannabis derived product specified in Table 7, Minimum
Test Sample Size, from every batch, and shall transfer the sample to an
approved laboratory for testing; the
remainder of the batch of dried, usable cannabis or concentrated
cannabis-derived product shall be segregated until the licensed non-profit
producer receives the results of laboratory testing report and determines
whether the batch meets the testing requirements of this rule;
|
Table 7. Minimum Test Sample Size |
||||
|
Targeted Parameter |
Sample Matrix |
Analysis Platforms
(Instrumentation Used by Lab) |
Minimum Amount Required for
Testing (grams) |
|
|
Cannabis Potency |
dried usable cannabis |
HPLC, LCMS |
1.0 |
|
|
concentrated cannabis-derived
products (CCDP) |
HPLC, LCMS |
1.0 |
||
|
non-concentrated cannabis-derived
products (NCCDP) |
HPLC, LCMS |
1.0 |
||
|
Cannabis Moisture Content |
dried usable cannabis |
n/a |
1.0 |
|
|
Mycotoxins |
dried usable cannabis, CCDP, or NCCDP |
HPLC, LCMS, LCMSMS |
1.0 |
|
|
Residual Solvents |
CCDP |
GC-FID, GC-PID/FID |
1.0 |
|
|
CCDP |
GCMS |
0.5 |
||
|
NCCDP |
GC-FID, GC-PID/FID |
5.0 |
||
|
NCCDP |
GCMS |
1.0 |
||
|
Absence of Salmonella spp. &
E. coli |
dried usable cannabis, NCCDP |
Culture, biochemical, antibody, or
nucleic acid- based assays shall be validated microbiological methodology
such as FDA, USP, AOAC, or equivalent. |
10.0 |
|
|
CCDP |
1.0 |
|||
|
Total Aerobic Microbial Count |
dried usable cannabis, CCDP, or NCCDP |
Direct culture, indirect culture,
or non-culture based. Must be validated
microbiological methodology such as FDA, USP, AOAC, or equivalent. |
10.0 (dried usable cannabis and
NCCDP) 1.00 (CCDP) |
|
|
Total Combined Yeast & Mold
Count |
||||
|
Bile-tolerant Gram-negative
Bacteria |
||||
|
Total Coliforms Count |
||||
|
Pesticides |
dried usable cannabis |
HPLC, LCMS, LCMSMS |
2.0 |
|
|
Heavy Metals |
dried usable cannabis, CCDP, NCCDP |
ICP-MS, FIMS |
0.5 |
|
|
Minimum required test size for
CCDP = 8 g, Minimum required test
sample size for NCCDP = 27.5g, Minimum
required test sample size for dried usable cannabis = 25.5 g. Minimum test sample size may
change if a validated method is approved by NMDOH MCP |
||||
(2) sample
selection: a non-profit producer and manufacturer shall collect and submit
samples for testing that are representative of the batch being tested; the
department may order that a non-profit producer or manufacturer modify its
sampling collection practices if it has reason to believe that samples that were
previously collected were not representative of an associated batch;
(3) documentation: a non-profit
producer and a manufacturer shall appropriately document the sampling and
testing of all dried cannabis and concentrated cannabis-derived product, and
shall utilize a department approved laboratory for the purpose of testing
usable cannabis;
(4) preservation
and inspection of testing records: a
licensed non-profit producer and a manufacturer shall maintain all results of
laboratory tests conducted on cannabis or cannabis derived products produced by
the licensed non-profit producer or manufacturer or their contractor for a
period of at least two years, and shall make those results available to
qualified patients and primary caregivers enrolled in the medical cannabis
program upon request; and
(5) disciplinary action: repeated failure to
pass testing may result in the imposition of disciplinary action(s) by the
department, consistent with this rule.
F. Remediation; subsequent testing: If a sample fails a given test (i.e., if the
sample does not measure below the action levels specified in this rule), the
non-profit producer or manufacturer (as applicable) shall determine whether
remediation is appropriate, and may pursue confirmatory testing at another
approved laboratory. In the event that a
non-profit producer or manufacturer attempts to remediate cannabis or a
cannabis derived product, the batch shall again be sampled and subjected to all
of the tests identified in this rule, except those required for heavy metals
and pesticides. A batch of usable
cannabis that fails a given test and that does not pass the required tests
subsequent to remediation conducted in accordance with the terms of this rule,
shall be destroyed in accordance with the wastage requirements of this
rule. A non-profit producer or
manufacturer may remediate cannabis or cannabis derived product in accordance
with the following:
(1) Dried usable cannabis: A non-profit producer may remediate dried
usable cannabis that has failed a microbiological test, by utilizing extraction
or distillation methods that remove or reduce contaminants in the batch such
that a subsequent sample from the batch measures within the action levels of a
required test. A non-profit producer may
not remediate dried usable cannabis that fails any other test required by this
rule;
(2) Cannabis derived product: A non-profit producer or manufacturer (as
applicable) may remediate a non-edible cannabis derived product (including
concentrated product) that has failed a microbiological test or residual
solvent test by utilizing extraction or distillation methods that remove or
reduce contaminants in the batch such that a subsequent sample from the batch
measures within the action levels of a required test. A non-profit producer or manufacturer may not
remediate non-edible cannabis derived product that fails any other test
required by this rule.
(3) Edible cannabis derived product: A
non-profit producer or manufacturer may not remediate an edible cannabis
derived product. Edible cannabis derived
products include brownies, cookies, candies, and similar finished products
intended for human consumption.
(4) Notice and wastage: If the batch of
usable cannabis cannot be remediated such that the sample measures within the action levels
of a required test, the non-profit producer or manufacturer shall notify the department
within 24 hours, and shall confirm the wastage and disposal of the usable
cannabis in accordance with this rule. The
wasted product shall be removed from inventory, and the removal from inventory
shall be tracked in an electronic system specified by the department.
(5) Testing and remediation protocols: A non-profit
producer and a manufacturer shall adopt and maintain on the premises protocols
regarding sampling, sample testing, remediation, and retesting, consistent with
this rule.
[7.34.4.10 NMAC - Rp, 7.34.4.9 NMAC,
6/23/2020]
7.34.4.11 WASTAGE OF CANNABIS; PERMITTED
METHODS: A non-profit producer or approved entity that wastes usable
cannabis or cannabis plants shall do so by rendering the cannabis unusable and
unrecognizable, in accordance with the requirements of this rule, prior to
removal from licensed premises. The
wastage of usable cannabis and cannabis plants shall be documented by the non-profit
producer or approved entity, shall be tracked by batch, and shall be recorded
in an electronic tracking system specified by the department. Wastage of usable cannabis or cannabis plants
shall occur only within the licensee’s ordinary business hours. A non-profit producer or approved entity
shall dispose of wasted cannabis and shall not attempt to incorporate wasted
cannabis products into any product intended for consumption.
A. Permitted
methods of wastage: Wastage of cannabis and cannabis derived
products shall be accomplished by the following permitted methods:
(1) Dried usable cannabis: wastage
of dried usable cannabis or cannabis plants shall be accomplished by grinding
and incorporating the cannabis into other ground material, such as soil,
compost material, or leaf and yard waste, so that the resulting mixture is at
least fifty percent non-cannabis material by volume;
(2) Non-liquid
cannabis derived product: wastage of
non-liquid cannabis derived products shall be accomplished in the same manner
as the wastage of dried usable cannabis; and
(3) Liquid cannabis derived product: Wastage of cannabis derived liquids shall be
accomplished by mixing the liquid with absorbent material such as cat litter,
sand, plastic waste, or sawdust, such that the liquid is fully absorbed into
the material.
B. Disposal of wasted cannabis: Disposal of wasted
cannabis and cannabis products shall be conducted in accordance with all
applicable waste disposal laws, including but not limited to hazardous waste
disposal laws (as applicable).
C. Holding time:
Usable cannabis and cannabis plants that
a licensee intends to waste shall be held in a secured designated holding area
for a minimum of 72 hours prior to being wasted. A licensee shall affix to each batch that is
held for wasting documents that record information concerning the batch,
including batch number or code, plant number, and weight. The batch to be wasted shall not be handled, moved,
or wasted during the 72 hour period, unless by specific instruction of the
department. Cannabis that is intended to
be wasted may be subject to inspection by the department or its designee.
D. Documentation
of wastage; retention: A licensee
shall record the wastage of usable cannabis and cannabis plants, including
batch number, weight, plant number, the name of the receiving solid waste
facility, dates of wastage and disposal, and any test results associated with a
wasted batch, using an electronic system specified by the department, and shall
deduct any wasted usable cannabis or cannabis plants from the licensee’s inventory. The electronic record shall be retained for
no less than two years following the disposal.
A licensee shall additionally document the wastage of any usable
cannabis or cannabis plants using a video recording, and shall retain the video
recording of the destruction for no less than 120 days. A licensee shall make the video recording of
the destruction available for the department’s inspection and copying upon the
department’s request.
E. Notice to department:
A non-profit producer or manufacturer
shall notify the department of the wastage of usable cannabis within five
business days of the wastage.
[7.34.4.11 NMAC - N, 6/23/2020]
7.34.4.12 DEPARTMENT TESTING; QUALITY ASSURANCE; RANDOMIZED TESTING; COMPLAINT
PROCEDURE:
A. Quality assurance testing by the department:
The department may within its discretion
conduct quality assurance sampling and testing of usable cannabis, and may
require a
producer or a manufacturer to provide samples of usable cannabis for this
purpose. The department may additionally adopt and
enforce a randomized testing schedule for the sampling and testing of usable
cannabis. The department may prohibit
the sale or distribution of usable cannabis that is determined by the
department to contain prohibited levels of contaminants, or that is found to
have been improperly tested, or may require remediation of such usable cannabis
that is consistent with the remediation standards of this rule.
B. Complaints: If the department or its designee receives a
complaint regarding the presence of mold, bacteria, or another contaminant in usable
cannabis produced by a non-profit producer, a manufacturer, or patient who
holds a personal production license, or if the department or its designee has
reason to believe that the presence of bacteria physical, microbiological,
chemical, or other contaminant may jeopardize the health of a patient, the
department or its designee may conduct an unannounced visit to the producer or
manufacturer and may require the producer or manufacturer to provide samples of
medical cannabis for testing by the department. Producers and manufacturers shall bear the
cost of any testing required by the department.
C. Department sampling and testing requirements:
Medical cannabis program employees and
their designees may possess medical cannabis samples for the sole purposes of
testing or transport to a testing facility.
The department or
its designee shall comply with the following testing requirements:
(1) the department or its designee shall
maintain chain of custody documentation for any medical cannabis samples taken;
(2) a written receipt shall be given
to the producer or manufacturer for all testing samples;
(3) all testing
samples shall be placed into a sealed container and clearly labeled;
(4) all testing samples shall be tested by the department or a
designated testing
facility; and
(5) the quantity
of cannabis that is gathered by the department from a producer or manufacturer for
testing purposes shall not exceed the applicable sample sizes identified in
Table 7.
[7.34.4.12 NMAC - Rp, 7.34.4.10
NMAC, 6/23/2020]
7.34.4.13 USE OF PESTICIDES BY LICENSED PRODUCERS: The use of any
pesticide by a licensed producer or manufacturer in the growth or manufacture
of cannabis or cannabis products shall be in accordance with the New Mexico
Pesticide Control Act, Section 76-4-1 et
seq., NMSA 1978, and associated regulations. Pesticides shall be stored in a secured area
that is accessible only to employees, and shall be segregated from usable
cannabis and cannabis plants and from any product or equipment that is utilized
in the manufacturing or production process.
[7.34.4.13 NMAC - Rp. 7.34.4.11
NMAC, 6/23/2020]
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.
[7.34.4.14 NMAC - Rp. 7.34.4.12
NMAC, 6/23/2020]
7.34.4.15 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
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.
(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 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
products are conducted in accordance with adequate security and sanitation
principles;
(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 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. 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 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”;
(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.
|
|||
|
Producer: |
Manufacturer: |
||
|
Name
of strain: |
Total
units: |
||
|
Net
weight: mg |
Manufacture/Production
date: / / |
Expiration
date: / / |
|
|
Laboratory Analysis |
|
||
|
|||
|
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. |
|
||
|
|
|
||
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, 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: % |
|
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. 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. 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 department;
(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 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 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;
(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. 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. 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. 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. 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 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. 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.
(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 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.
(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. 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.
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.
(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. 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 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]
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. 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. 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. The calibration range 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.
(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.
(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. 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;
(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 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 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 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 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 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 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. 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.
(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. 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. 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 written acknowledgement of the limitations of the right to
use and possess cannabis for medical purposes in New Mexico.
[7.34.4.21
NMAC - Rp, 7.34.4.18 NMAC, 6/23/2020]
7.34.4.22 NON-PROFIT PRODUCER APPLICATION AND LICENSURE
REQUIREMENTS: An applicant for
initial or renewal non-profit producer licensure shall provide materials and
information to the department, in accordance with the provisions of this
section, in order to be considered for a license to produce medical
cannabis. A licensed non-profit producer
shall also promptly submit revised versions of any such materials in the event
that the materials or their content change.
A. Organizational information and
materials: An applicant for non-profit producer licensure
shall submit to the department:
(1) proof that the private entity is a non-profit corporation in
good standing with the NM secretary of state pursuant to Section 53-8-1 et
seq., NMSA 1978;
(2) proof
that the non-profit producer is in good standing with the New Mexico taxation
and revenue department;
(3) copies of the entity’s articles
of incorporation;
(4) copies of the entity’s by-laws;
(5) verification that the board of directors of the non-profit
includes, at a minimum, five voting members, including one medical provider
limited to a physician (MD or OD), a registered nurse, nurse practitioner, licensed practical nurse, or physician assistant, and three
patients currently qualified under department regulations and the Lynn and Erin
Compassionate Use Act, Section 26-2B-1
et seq., NMSA 1978;
(6) a list of all persons or business
entities having direct or indirect authority over the
management or policies of the private
entity;
(7) a list of all persons or business entities having any
ownership interest in any property utilized by the non-profit producer, whether
direct or indirect, and whether the interest is in
land, building(s), or other material, including owners of any business entity
that owns all or part of land or building(s) utilized;
(8) the identities and financial information, including
information concerning loans and monetary investments, of all creditors
currently holding a security interest in the non-profit producer or premises of
the non-profit producer, if any; and
(9) a business plan showing how the private entity intends to
fund its operations and become a successful producer, including information
concerning personnel, horticulture, technology, and funding sources.
B. Production and distribution
information and materials: An applicant for non-profit producer
licensure shall submit to the department:
(1) an acknowledgement that production, at any time, shall not
exceed the total of cannabis plants that the non-profit entity has been
approved to produce as well as an inventory of usable
cannabis that reflects current patient needs;
(2) a production plan that includes the non-profit entity’s plan
for the growth, cultivation, and harvesting of medical cannabis;
(3) a
written set of distribution criteria for qualified patients or primary
caregivers appropriate for cannabis services that describes the method by which
and locations at which distribution will occur;
(4) a complete written description of the means that the non-profit entity shall employ to safely dispense
cannabis and cannabis-derived products to qualified patients and qualified
patients’ primary caregivers;
(5) an
attestation that qualified patients shall not be permitted to consume cannabis
or cannabis-derived products on the entity’s property, unless the consumption
occurs in a department approved cannabis consumption area;
(6) an
attestation that the entity will require the presentation of a
department-issued identification card and a valid New Mexico photo
identification card or a passport prior to selling or otherwise distributing
cannabis or cannabis derived products to qualified patients and primary
caregivers;
(7) a description and sample of the packaging of the usable
cannabis and cannabis-derived products that the non-profit producer shall utilize, including a label that satisfies the labeling
requirements of this rule; and
(8) a written quality assurance plan.
C. Facility information: An
applicant for non-profit producer licensure shall submit to the department:
(1) a description of the facilities
and equipment that shall be used in the production distribution of
cannabis, and manufacture of cannabis-derived products (as applicable);
(2) proof that the facilities are not within 300 feet of any
school, church, or daycare center; or alternatively, proof that any school,
church, or daycare center that is located within 300 feet of a building to be
used by the applicant did not occupy that location prior to the applicant
initially seeking to become licensed to operate at the location; and
(3) a description of the methods and
device or series of devices that shall be used to
provide security.
D. Educational methods and materials: An applicant for non-profit producer licensure
shall submit to the department:
(1) a description of the private
entity’s means for educating the qualified patient and the primary caregiver on the limitation of the right to possess and use
cannabis;
(2) a description of the means the private entity shall employ
to make qualified patients or the primary caregiver aware of the quality of the
product;
(3) a description of ingestion
options of usable cannabis provided by the private entity;
(4) a description of inhalation
techniques that shall be provided to qualified patients;
(5) a description of potential side
effects and how the private entity will educate qualified patients and the
qualified patient’s primary caregivers regarding potential side effects;
(6) a
description of the means the private entity shall employ to make qualified
patients or the primary caregiver aware of how to report adverse events related
to medical cannabis use; and
(7) a
description of the means the private entity shall employ to make qualified
patients or the primary caregiver aware of how to report concerns regarding the
private entity’s products and services.
E. Sales record forms: A
licensed non-profit producer that applies for renewal of licensure shall submit
to the department a sample
of the non-profit producer’s sales record form(s), which shall identify (among
other items) the name of the purchaser, the date of the sale, the quantity, and
price of medical cannabis sold. A
non-profit producer that applies for renewal of licensure shall additionally
submit a profit and loss statement and balance sheet quarterly and as requested
by the department.
F. Business licensure; TRD certificate: An applicant for non-profit producer
licensure shall submit a current business license and tax and revenue
registration certificate.
G. Policies and procedures: An applicant for non-profit producer
licensure shall submit to the department copies of
policies and procedures developed, implemented, and to be maintained on the
premises of the private entity’s facility.
The applicant shall verify that the private entity will comply with the
stated terms of the policies and procedures as written and submitted to the
department.
H. Personnel records: An
applicant for non-profit producer licensure shall submit to the department:
(1) separate nationwide and statewide
criminal history screening documentation, in accordance with the provisions of
this rule;
(2) samples of the personnel records to be retained by the
private entity for each employee as required by this rule, including:
(a) a sample application for
employment;
(b) state and federal employment
documentation;
(c) a sample written job descriptions
or employment contracts developed for all employee positions, to include
duties, authority, responsibilities,
qualifications, and supervision;
(d) payment
or payroll records for all individuals associated with
a non-profit producer renewal applicant’s production and distribution facility,
to include board members, persons having direct or indirect authority over
management or policies, and employees submitted quarterly and as requested by the department.
(3) an on-site training curriculum
(unless the private entity intends to enter into contractual relationships with
outside resources capable of meeting employee training needs) that addresses, at a minimum, the following topics:
(a) state and federal confidentiality laws, including the Health
Insurance Portability and Accountability Act of 1996 (HIPAA);
(b) professional conduct and ethics;
(c) the
Lynn and Erin Compassionate Use Act and department of health rules;
(d) informational developments in the field of medical use of cannabis;
(e) employee safety and security training
addressing, at a minimum, the proper use of the security measures and controls
that have been adopted, and specific procedural
instructions on how to respond to an emergency, including a robbery or violent
accident;
(f) robbery awareness and
conflict de-escalation training for all employees;
(g) general food safety
training.
(4) proof of HIPAA certification for all individuals associated
with the private entity, including all board members, persons having direct or indirect authority over management or
policies, and employees.
I. Other materials: An
applicant for non-profit producer licensure shall submit to the department:
(1) a
description of the department approved laboratory or laboratories that the
non-profit entity will utilize for testing usable cannabis in
accordance with this rule, and the type(s) of testing that the approved
laboratory or laboratories will perform for the non-profit entity;
(2) the
name of any courier that the non-profit entity intends to use for transport of
usable cannabis to qualified patients and primary caregivers; and
(3) such
other information as the private entity wishes to provide and such other information as the department may reasonably request.
J. Patient identification and sales records: A licensed non-profit producer shall retain
clear, legible photocopies or electronic copies of current registry
identification cards and current New Mexico photo identification cards of all
qualified patients and primary caregivers served by the non-profit entity. A licensed non-profit producer shall also
create and retain materials that document every instance in which usable
cannabis was sold or otherwise distributed to another person or entity,
including documentation of the recipient, type, quantity, and batch of the
usable cannabis.
K. Material safety data sheets: A licensed non-profit producer shall maintain
current material safety data sheets on-site for all chemicals used, including
but not limited to cleaning compounds, sanitizing agents, and pesticides.
L. State
and local laws: A licensed
non-profit producer shall comply with all applicable state and local laws regarding
construction, occupancy, and operation of a facility or building, including but
not limited to zoning, occupancy, licensing, and building codes.
[7.34.4.22 NMAC - Rp, 7.34.4.19
NMAC, 6/23/2020]
7.34.4.23 SECURITY REQUIREMENTS FOR
LICENSED PRODUCERS: Private non-profit entities licensed to
produce medical cannabis shall comply with the following requirements to ensure that
production and distribution facilities are located on secure grounds.
A. The
non-profit producer shall provide and maintain in each facility a fully
operational security alarm system.
B. The non-profit producer shall
conduct a monthly maintenance inspection and make all
necessary repairs to ensure the proper operation of the alarm system and, in
the event of an extended mechanical malfunction that exceeds an eight hour
period, provide alternative security that shall include closure of the
premises.
C. The non-profit producer shall
maintain documentation for a period of at least 24 months of all inspections,
servicing, alterations, and upgrades performed on the security alarm system;
all documentation shall be made available within 24
hours of a department representative’s request; failure to provide equipment
maintenance documentation within the 24 hour period shall subject the licensed
producer to the sanctions and penalties provided for in this rule; the 24 hour
period shall not include holidays and weekends.
[7.34.4.23 NMAC - Rp, 7.34.4.11
NMAC, 6/23/2020]
7.34.4.24 RECALLS OF USABLE CANNABIS:
A. All non-profit
producers and approved manufacturers shall establish and implement written
procedures for recalling usable cannabis and products that have been sold or
otherwise distributed to qualified patients, primary caregivers, or other
cannabis establishments. Recall
procedures shall be made available for the department’s inspection upon
request. The recall procedures shall identify:
(1) The
circumstances in which a recall will be conducted, including but not limited to
circumstances involving the mislabeling of products and the contamination of
products.
(2) Personnel
responsible for implementing the recall procedures.
(3) Procedures
for notification of all customers who have, or reasonably could have, obtained an
affected product, including communication and outreach via media, as
appropriate.
(4) Procedures
for notification of any other cannabis establishment that supplied or received
the recalled product.
(5) Instructions
to be provided to qualified patients, primary caregivers, and cannabis
establishments for the return or destruction of the recalled product.
(6) Procedures
for the collection and wastage (as may be required by this rule) of any
recalled product, which shall meet the requirements of this section.
B. All
recalled products that are intended to be destroyed shall be wasted in
accordance with the wastage requirements of this rule.
C. The
licensee shall notify the department of any recall within 24 hours of
initiating the recall.
D. The
department may order the immediate recall of a usable cannabis product if it
deems such action necessary to protect public health and safety.
[7.34.4.24 NMAC - N, 6/23/2020]
7.34.4.25 DENIAL OF AN INITIAL PRODUCER LICENSE:
A. Administrative review of license
application denials: An applicant whose
initial application for a producer license is denied by the medical cannabis
program director or designee may request an administrative review by the
administrative review committee. The
written notice of denial shall include a
statement of the right to request such a review.
B. No administrative review of
determinations made by the secretary:
An applicant whose initial application for a producer license was for
any reason not approved by the secretary (rather than the program director or designee) shall not be entitled to further review by
the department, but may reapply at a later date.
C. Procedure for requesting informal
administrative review:
(1) An
applicant given notice of an application denial
by the medical cannabis program director or designee may submit a written
request for a record review. To be effective, the written request shall:
(a) be made within 30 calendar days,
as determined by the postmark, from the date of
the denial notice issued by the department;
(b) be properly addressed to the medical cannabis program;
(c) state the applicant’s name,
address, and telephone numbers;
(d) state the applicant’s proposed
status as a licensed producer; and
(e) provide a brief narrative
rebutting the circumstances of the application denial.
(2) If the applicant wishes to submit additional documentation for
consideration, the applicant shall include such additional documentation when
submitting the request for administrative review.
D. Administrative review proceeding: The administrative review proceeding shall be a closed proceeding that is limited to an
administrative review of written application materials and documents offered to
verify eligibility. The administrative
review is not an adjudicatory hearing. The administrative review shall be conducted by the administrative review committee. In cases where the
administrative review committee finds the need for additional or clarifying
information, the review committee shall request that the applicant supply such
additional information within the time set
forth in the committees’ request.
E. Final determination:
(1) Content: The administrative
review committee shall render a written decision setting forth the reasons for
the decision.
(2) Effect: The decision of the administrative review committee is the final
decision of the informal administrative review proceeding.
(3) Notice: A copy of the
decision shall be mailed to the applicant.
F. Judicial review: Except as otherwise provided by law, there shall be no right to judicial review of a
decision by the program director or designee, the administrative review
committee, or the secretary.
[7.34.4.25 NMAC - Rp, 7.34.4.21
NMAC, 6/23/2020]
7.34.4.26 PROHIBITIONS, RESTRICTIONS, AND LIMITATIONS ON THE PRODUCTION
AND DISTRIBUTION OF MEDICAL CANNABIS AND CRIMINAL PENALTIES:
A. Participation in the medical
cannabis licensing program by a licensed producer or approved entity, or the
employees or contractors of a licensed producer or approved entity, does not
relieve the producer, approved entity, employee, or contractor from criminal
prosecution or civil penalties for activities not authorized in this rule and the act.
B. Locations of production, distribution, and manufacture: Production of medical cannabis and
distribution of medical cannabis to qualified patients or their primary
caregivers shall take place at locations (or, with respect to distribution, categories of locations) described in the non-profit producer’s production
and distribution plan approved by the department, and shall not take place at
locations that are within 300 feet of any school, church, or daycare
center. For purposes of this rule,
delivery to the residence of a qualified patient or primary caregiver shall not
be deemed “distribution”.
C. Fraudulent misrepresentation: Any person who makes a fraudulent
representation to a law enforcement officer about the person’s participation in
the medical cannabis program to avoid arrest or prosecution for a
cannabis-related offense is guilty of a petty misdemeanor and shall be sentenced in accordance with the provisions of Section
31-19-1 et seq., NMSA 1978.
D. Unlawful distribution: If a licensed producer or employee of a
licensed producer sells, distributes, dispenses, or transfers cannabis to a
person not approved by the department pursuant to this rule and the
act, or obtains or transports cannabis outside New Mexico in violation of
federal law, the licensed producer or employee of the licensed producer shall
be subject to arrest, prosecution, and civil or criminal penalties pursuant to
state law.
E. Revocation of registry
identification card, licensed primary caregiver card, license to produce or
distribute: Violation of any
provision of this rule may result in disciplinary action, in accordance with
this rule.
[7.34.4.26 NMAC - Rp, 7.34.4.22 NMAC,
6/23/2020]
7.34.4.27 CANNABIS CONSUMPTION AREAS:
A. General
provisions: The smoking, vaporizing,
and ingestion of medical cannabis products by qualified patients is permitted
within cannabis consumption areas, designated by the department, that are
located on the premises of licensed non-profit producers. Cannabis
consumption areas may only be operated by licensed non-profit producers, at
medical cannabis dispensary locations designated by the department. Alcohol is prohibited in cannabis consumption
areas. A licensed non-profit producer
that operates a cannabis consumption area shall comply with all applicable
state and local laws, including but not limited to zoning, occupancy,
licensing, and building codes.
Additionally, a licensed non-profit
producer that operates a designated cannabis consumption area shall:
(1) restrict
access to the cannabis consumption area to qualified patients and their primary
caregivers and authorized personnel of the non-profit producer;
(2) ensure that
consumption of cannabis in the cannabis consumption area is not visible from
any public place or from outside the cannabis consumption area; and
(3) require that
qualified patients who consume cannabis in a cannabis consumption area either
leave the non-profit producer’s premises with a designated driver or utilize
other lawful means of transportation from the non-profit producer’s premises.
B. Application; operations plan: A
licensed non-profit producer shall apply for
and obtain prior approval from the department before operating a cannabis
consumption area. The licensed non-profit producer shall include an operations plan with its application that includes
the following:
(1) operating
hours of the cannabis consumption area;
(2) plan
for limiting access to qualified patients and primary caregivers access and
verification process;
(3) security plan
addressing overall security measures, including but not limited to plans for
video surveillance, fire safety, public disturbances, refusal of service, and
emergency evacuation;
(4) plan for ensuring that
only qualified patients, primary caregivers, and authorized staff can access
cannabis consumption areas;
(5) plan
for educating patients and primary caregivers about the dangers of driving
under the influence of cannabis;
(6) plan concerning
disposal of wasted cannabis and cannabis-related paraphernalia;
(7) plan concerning
measures to limit potential allergic reactions by qualified patients and
primary caregivers who visit the cannabis consumption area;
(8) plan to ensure that
qualified patients who are minors are accompanied by their primary caregiver at
all times while on the premises of a cannabis consumption area;
(9) attestation that access to cannabis consumption areas will be limited to
qualified patients and their primary caregivers and authorized personnel of the
non-profit producer;
(10) attestation that
consumption of cannabis in the cannabis consumption area will not be visible
from any public place or from outside the cannabis consumption area;
(11) attestation that the
non-profit producer will require that qualified patients who consume cannabis
in a cannabis consumption area either leave the non-profit producer’s premises
with a designated driver (who shall be identified to the non-profit producer by
the qualified patient or primary caregiver) or utilize other lawful means of
transportation from the non-profit producer’s premises; and
(12) such additional
information or materials as the department may require.
C. Amended license: The licensed non-profit producer shall apply
for amended licensure, and shall obtain approval from the department, at least
30 days prior to implementing any change of location of a cannabis consumption
area or any substantial change to any portion of the non-profit producer’s
cannabis consumption area operations plan.
[7.34.4.27 NMAC - N, 6/23/2020]
7.34.4.28 [RESERVED]
[7.34.4.28 NMAC - Rp. 7.34.4.28 NMAC,
6/23/2020; A, 10/8/2020; A, 3/23/2021; Repealed, 2/22/2022]
7.34.4.29 ENFORCEMENT OF PARENTAL RESPONSIBILITY ACT:
A. The medical cannabis program’s
approval of an employee of a non-profit producer or an approved entity to work
for such producer or approved entity may be suspended, and a request for an
individual to be approved to work for such a producer or approved entity may be
denied, for failure of the approved employee or prospective employee to comply
with a judgment and order for child support issued by a district or tribal
court or a subpoena or warrant relating to paternity or child support
proceedings, as provided in the Parental Responsibility Act, Section 40-5A-1 et
seq., NMSA 1978.
B. Procedures for enforcement of the Parental
Responsibility Act:
(1) List of obligors: The New Mexico human services department (HSD)
will issue to the medical cannabis program a certified list of obligors
(meaning persons who have been ordered to pay child support pursuant to a
judgment and order for support issued by a district or tribal court) not in
compliance with their judgment and order of support or a
subpoena or warrant relating to paternity or child support proceedings.
(2) Notice
of non-compliance: Upon
determination by the medical cannabis program that the name and social security
number of an approved employee or prospective employee of a non-profit producer
or an approved entity appear on the certified list of obligors, the medical
cannabis program shall notify the approved employee or prospective employee in
writing. The medical cannabis program
may send a copy of the notice of non-compliance to the non-profit producers or
approved entities affiliated with the approved employee or prospective
employee. The notice shall state that
the medical cannabis program intends to suspend the approved employee’s
approval to work for the non-profit producer or approved entity, or deny the
prospective employee’s approval to work for the non-profit producer or approved
entity, unless the approved employee or prospective employee, within thirty
days of the date that the written notice is issued, provides to the medical
cannabis program a certified statement from the human services department that
he or she is in compliance with a judgment and order for support or subpoenas
or warrants relating to paternity or child support proceedings.
(3) Notice of contemplated action: If the approved employee or prospective
employee of a non-profit producer or approved entity does not provide to the
medical cannabis program the certified statement of compliance from HSD within
thirty days of the date that the written notice is issued, the medical cannabis
program shall issue a notice of contemplated action to the approved employee or
prospective employee, stating that the medical cannabis program has grounds to suspend
or deny the individual’s authorization to work for the non-profit producer or
approved entity, and that the medical cannabis program shall take such action
unless the individual mails a letter (certified mail, return receipt requested)
requesting a hearing within 20 days after service of the notice requesting a
hearing, or provides the bureau, within 30 days of receipt of the notice of
contemplated action, a statement of compliance from HSD. The medical cannabis program may send a copy
of the notice of contemplated action to the non-profit producers or approved
entities affiliated with the approved employee or prospective employee.
(4) Disputes regarding findings of non-compliance:
If the approved employee or prospective
employee disagrees with the finding of non-compliance, or wishes to come into
compliance, the approved or prospective employee shall contact the HSD child
support enforcement division.
(5) Hearings: The hearing process of this rule part shall
apply to hearings conducted pursuant to this section; provided that, in any such
hearing, the following standards shall also apply:
(a) The
presence of an individual’s name and social security number on the HSD list of
obligors is deemed conclusive evidence of an individual’s non-compliance that
requires the medical cannabis program to deny or withdraw approval of an
individual to work for a non-profit producer or approved entity, unless the individual
provides the medical cannabis program with a certified statement of compliance,
in which case the medical cannabis program shall be precluded from taking
further action under this section;
(b) When an action is taken against an approved
employee or prospective employee of a non-profit producer or approved entity
because the individual is not in compliance with a judgment and order of
support or a subpoena or warrant relating to paternity or child support
proceedings, the order shall state that the individual’s approval to work for a
non-profit producer or approved entity shall be reinstated upon presentation to
the medical cannabis program of a certified statement of compliance from HSD;
and
(c) The
secretary may also include in the order any other conditions necessary to
comply with requirements for reapplication and re-issuance of licensure,
including, but not limited to, requiring payment of a surcharge fee of $50, in
addition to any other applicable fees.
[7.34.4.29 NMAC - N, 6/23/2020]
7.34.4.30 MONITORING AND CORRECTIVE ACTIONS:
A. Monitoring:
(1) The
department or its designee may perform on-site assessments of a licensed
producer or producer-applicant, an approved manufacturer or
manufacturer-applicant, an approved laboratory or a laboratory-applicant, and
an approved courier or courier-applicant, to determine
compliance with these rules or submissions made pursuant to this rule. The department may enter the premises of a
licensed producer, approved manufacturer, approved laboratory, or approved
courier at any time to assess or monitor.
(2) 24 hours’ notice shall be provided to personal production
license holders prior to an on-site assessment,
except when the department has reasonable suspicion to believe that providing
notice will result in the destruction of evidence, or that providing such
notice will impede the department’s ability to enforce these regulations.
(3) The department may review any and all records of a licensed
non-profit producer, a qualified patient or primary caregiver, an approved
manufacturer, approved laboratory, and approved courier, and may require and
conduct interviews with such persons or entities and persons affiliated with
such entities, for the purpose of determining compliance with department rules and applicable laws.
(4) All licensed producers, approved manufacturers, approved
laboratories, and approved couriers shall provide the department or the
department’s designee immediate access to any material and information
necessary for determining compliance with this rule.
(5) Failure by a licensed producer,
approved manufacturer, approved laboratory, or approved courier to provide the
department access to the premises or materials may result in disciplinary
action(s), in accordance with this rule.
(6) Any failure to adhere to these rules that is documented by the department during
monitoring may result in disciplinary action, in accordance with this rule.
(7) The department shall refer
complaints alleging criminal activity that are made against a licensed
producer, approved manufacturer, approved laboratory, or approved courier to
appropriate New Mexico state or local law enforcement authorities.
B. Financial records: A
licensed non-profit producer and a manufacturer shall maintain detailed sales records in a manner and format approved by the department, and
shall inform the department of the location where such records are kept, and
promptly update that information if the records are removed.
(1) Access: The department and its agents shall have reasonable access to the financial
records of a licensed non-profit producer manufacturer, laboratory, or courier,
including but not limited to sales records and data from point of sale systems,
and shall be granted immediate access to inspect or copy those records upon
request. A patient shall be granted
reasonable access to a licensed non-profit producer’s or manufacturer’s sales
records for that patient upon request.
(2) Audit: A licensed non-profit producer shall submit
the results of an annual audit to the department no later than 90 days after
the end of each fiscal year of the licensed non-profit. For the purposes of this section, the fiscal
year of a non-profit producer shall be the 12 month cycle identified by the
producer in its filings with the New Mexico taxation and revenue
department. The annual audit shall be
conducted by an independent certified public
accountant; the costs of any such audit shall be borne by the private
entity. Results of the annual audit
shall be forwarded to the medical cannabis program director or designee. The department may also periodically require,
within its discretion, the audit of a non-profit producer’s financial records
by the department.
(3) Quarterly
reports: A
non-profit producer shall submit reports on at least a quarterly basis, or as
otherwise requested, and in the format
specified by the department. The
quarterly report shall include at a minimum:
(a) number
of qualified patients and primary caregivers who purchased usable cannabis;
(b) total
number of retail transactions;
(c) average
amount (in units) purchased per retail transaction;
(d) number
of units provided without charge;
(e) number
of cannabis plants in production, including mature plants and seedlings;
(f) number
of cannabis plants harvested;
(g) total
yield of usable cannabis harvested from cannabis plants (in grams);
(h) average
yield per plant (in grams);
(i) amount
of cannabis (in grams) sold by wholesale;
(j) amount
of cannabis (in grams) purchased by wholesale;
(k) number
of live cannabis plants (including clones) and cannabis seeds sold;
(l) amount
of dried cannabis leaves and flowers in stock;
(m) average
price per gram of dried cannabis leaves and flowers;
(n) total
amount of dried cannabis leaves and flowers sold (in units);
(o) total
sales of dried cannabis leaves and flowers (in dollars and units);
(p) amount
of cannabis derived products in stock (in units);
(q) total
amount of cannabis derived products sold (in units);
(r) total
sales of cannabis derived products (in dollars and units);
(s) amount
of gross receipts tax paid to the New Mexico department of taxation and revenue;
(t) all
quality testing reports, to be included as attachments; and
(u) such
additional information as the department may request.
C. Corrective action:
(1) If
violations of requirements of this rule are cited on the basis of a violation
that is directly observed in the course of a monitoring visit at an approved
location, or on the basis of a review of financial records, the licensed
producer, manufacturer, laboratory, or courier shall be provided with an
official written report of the findings within seven
business days following the monitoring visit or the review of financial
records.
(2) Unless otherwise specified by the department, the licensed
producer, manufacturer, laboratory, or courier shall correct the violation within
five calendar days of receipt of the official
written report citing the violation(s).
(3) The violation shall not be deemed corrected until the
department verifies in writing within seven calendar days of receiving notice
of the corrective action that the corrective
action is satisfactory.
(4) If the violation has not been corrected, the department may
issue a notice of contemplated action to suspend, revoke, or take other
disciplinary action against the license of the
producer, manufacturer, laboratory, or courier, in accordance with the
provisions of this rule.
D. Suspension of license without prior
hearing: If immediate action is
required to protect the health and safety of the general public, a qualified
patient, or a primary caregiver, the program director or
designee may suspend the license of a non-profit producer or personal
production license holder without notice, and may immediately withdraw approval
for a laboratory, manufacturer, or courier without notice.
(1) A licensee or
approved entity whose license has been summarily suspended or whose approval
has been withdrawn may request a record review in accordance with this part.
(2) The
record review requested subsequent to a summary suspension shall be conducted
by the administrative review committee.
(3) The
administrative review committee shall conduct the record review on the summary
suspension or withdrawal of approval by reviewing all documents submitted by
both licensee and the department.
(4) The
sole issue at a record review on a summary suspension or withdrawal of approval
is whether the license shall remain suspended or whether the approval shall
remain withdrawn pending a final adjudicatory hearing and subsequent ruling by
the secretary.
(5) A
licensee or approved entity given notice of summary suspension or summary
withdrawal by the program may submit a written request for a record
review. To be effective, the written
request shall:
(a) be
made within 30 calendar days, from the date of the notice issued by the
department, as determined by the postmark;
(b) be
properly addressed to the medical cannabis program;
(c) state
the applicant’s name, address, and telephone numbers;
(d) provide
a brief narrative rebutting the circumstances of the suspension or withdrawal,
and
(e) include
attachments of any additional documentation that the individual or entity
wishes to be considered in the record review.
[7.34.4.30 NMAC - Rp, 7.34.4.23
NMAC, 6/23/2020]
7.34.4.31 DISCIPLINARY ACTIONS AND APPEAL PROCESS:
A. Notice of disciplinary action: The department
may issue notice of an immediate disciplinary action, as specified in this
rule, or notice of contemplated disciplinary action. Notice shall be served upon a licensee’s
contact person of record. Notice shall
be served via certified U.S. postal mail.
A notice shall be deemed to have been served on the date borne by the
return receipt showing delivery or the last attempted delivery of the notice or
decision to the addressee or refusal of the addressee to accept delivery of the
notice or decision.
B. Grounds for disciplinary action:
Disciplinary action may be taken against a producer-applicant, a
licensed producer, a manufacturer-applicant or approved manufacturer, a
laboratory applicant or approved laboratory, or an approved courier or courier-applicant. Disciplinary action may include revocation, suspension, or denial of an application,
license, or department approval, monetary penalties, immediate suspensions and
revocations in accordance with this rule, and other action. Disciplinary actions may be imposed in any
combination, and the actions described in this paragraph, including suspension
and monetary fines, are not exclusive of one another. Disciplinary action may be imposed for:
(1) A
major violation implicating public safety, including:
(a) failure
to comply with or satisfy any provision of this rule that implicates public
safety;
(b) diversion,
inversion, or attempted diversion or inversion, of cannabis or a
cannabis-derived product, as determined by the department;
(c) threatening
or harming a patient, a medical practitioner, or an employee of the department;
(d) intentionally
destroying, damaging, altering, removing or concealing evidence of a violation
under this rule, attempting to do so, or asking or encouraging another person to
do so;
(e) deliberately
purchasing usable cannabis, cannabis-derived products or cannabis plants from
out of state or outside the legal medical cannabis system; or
(f) other
conduct that shows willful or reckless disregard for health or safety;
(2) A
major violation not implicating public safety, including:
(a) failure
to pay a required monetary penalty;
(b) failure
to comply with the department’s requested access to premises or materials;
(c) failure
to allow or impedance of a visit by authorized representatives or designees of
the department;
(d) falsification
or misrepresentation of any material or information submitted to the
department;
(e) failure
to adhere to any acknowledgement, verification, or other representation made to
the department;
(f) failure
to submit or disclose information required by this rule or otherwise requested
by the department;
(g) failure
to correct any violation of this rule cited as a result of a review or audit of
financial records or other materials, or cited as a result of a monitoring
visit or site inspection;
(h) a
pattern of non-major license violations;
(i) non-compliance
with tax obligations as determined by a taxation regulatory authority;
(j) exceeding
the plant limit of the license; and
(3) Any
other violation, including:
(a) failure
to comply with or satisfy any provision of this rule that does not implicate
public safety;
(b) failure
to take a video recording of the wastage of usable cannabis, in accordance with
this rule; and
(c) selling
or transferring to a qualified patient or primary caregiver a quantity of
usable cannabis greater than the maximum amount permitted by department rule.
C. Fines: Disciplinary actions against a licensed
non-profit producer, approved manufacturer, approved laboratory, or approved
courier may include the imposition of monetary penalties, which may be assessed
by the department in the amount of:
(1) up
to $50,000 for each major violation implicating public safety;
(2) up
to $20,000 for each major violation not implicating public safety;
(3) up
to $5,000 for each other violation.
D. Persons and entities who may request
a hearing: The following persons
or entities may request a hearing to contest an action or proposed action of
the department, in accordance with this rule:
(1) a
licensed producer whose license has been
summarily suspended or who has received a notice of contemplated action to suspend,
revoke, or take other disciplinary action;
(2) a personal production licensure applicant whose application is denied
for any reason other than failure to submit a completed application or failure
to meet a submittal requirement of this rule;
(3) an
approved manufacturer whose approval status has
been summarily suspended or who has received a
notice of contemplated action to suspend, revoke, or take other disciplinary
action;
(4) a
manufacturer-applicant whose application is denied for any reason other than
failure to submit a completed application or failure to meet a submittal
requirement of this rule;
(5) an
approved laboratory whose approval status has been summarily suspended or who has received a notice of contemplated
action to suspend, revoke, or take other disciplinary action;
(6) a
laboratory-applicant whose application is denied for any reason other than
failure to submit a completed application or failure to meet a submittal
requirement of this rule;
(7) an
approved courier whose approval status has been summarily suspended or who has received a notice of contemplated
action to suspend, revoke, or take other disciplinary action;
(8) a
courier-applicant whose application is denied for any reason other than failure
to submit a completed application or failure to meet a submittal requirement of
this rule; and
(9) a person whose
participation with a licensed producer or approved entity is prohibited based
on a criminal background check.
E. Closure of applications period: A hearing may not be requested by a person or
entity whose application for licensure is denied solely on the basis that the
applicable applications period is closed.
F. Timing and content of request for hearing: The
appellant shall mail the request for hearing within 30 calendar days of the
date that the notice of contemplated action is received, or in the case of an
immediate action, within 30 days of the action.
The request shall:
(1) be properly addressed to
the medical cannabis program;
(2) be mailed to the medical
cannabis program via certified U.S. postal mail;
(3) state the
requestor’s name, address, and telephone number(s); and
(4) include a statement of the
issue(s) that the appellant considers relevant to the review of the action.
G. Hearing process:
(1) All
hearings held pursuant to this section shall be conducted by a hearing officer
appointed by the secretary.
(2) Hearings shall be conducted in
Santa Fe, NM or, with the consent of the parties, in another location.
(3) Due to federal and state
confidentiality laws, hearings held pursuant to this section that concern
qualified patients, patient-applicants, licensed producers or
producer-applicants, shall be closed to the public. Portions of hearings may further be closed to
prevent the disclosure of confidential information.
(4) The hearing shall be recorded on
audiotape or other means of sound reproduction.
(5) Any hearing provided for in this
rule may be held telephonically, with the consent of the parties.
H. Scheduling: The department shall schedule and hold the hearing as soon as practicable, however; in any event no later than 60
calendar days from the date the department receives the appellant’s request for
hearing. The hearing examiner shall
extend the 60 day time period upon motion for good cause shown or the parties
may extend the 60 day time period by mutual agreement. The department shall issue notice of hearing,
which shall include:
(1) a statement of the location, date, and time of the hearing;
(2) a short and plain statement of
the legal authority under which the hearing is to be held; and
(3) a short and plain statement of
the subject of the hearing.
I. Presentation of evidence: All parties shall be given the opportunity to
respond and present evidence and argument on all
relevant issues.
J. Record of proceeding: The record of the proceeding shall include
the following:
(1) all pleadings, motions, and
intermediate rulings;
(2) evidence and briefs received or considered;
(3) a statement of matters officially noticed;
(4) offers of proof, objections, and
rulings thereon;
(5) proposed findings and conclusions; and
(6) any action recommended by the hearing examiner.
K. Audio recording: A
party may request a copy of the audio recording of the proceedings.
L. Procedures and evidence:
(1) A
party may be represented by a person licensed to practice law in New Mexico or
a non-lawyer representative, or may represent himself or herself.
(2) The rules of evidence as applied
in the courts do not apply in these proceedings. Any relevant evidence shall be admitted. Irrelevant, immaterial, or unduly repetitious
evidence may be excluded.
(3) The experience, technical competence, and specialized
knowledge of the hearing examiner, the department or the department’s staff may be used in the evaluation of evidence.
(4) An appellant’s failure to appear at the hearing at the date and time noticed for the hearing shall constitute a default.
M. Conduct of proceeding: Unless the hearing examiner determines that a
different procedure is appropriate, the hearing shall be conducted in
accordance with the procedures set forth in this rule. The following
procedures shall apply:
(1) the appellant shall present an opening statement and the
department may present an opening statement or reserve the statement until
presentation of the department’s case;
(2) after the opening statements, if
made, the appellant shall present its case;
(3) upon the conclusion of the
appellant’s case, the department shall present its case;
(4) upon conclusion of the appellee’s case, the appellant may
present rebuttal evidence; and
(5) after presentation of the
evidence by the parties, the parties may present closing argument.
N. Burden of proof: The appellant shall
bear the burden of establishing by a preponderance of the evidence that the
decision made or proposed by the department should be reversed or modified.
O. Continuances: The hearing examiner may grant a continuance
for good cause shown. A
motion to continue a hearing shall be made at least 10 calendar days before the
hearing date.
P. Telephonic hearings:
(1) Any
party requesting a telephonic hearing shall do so no less than 10 business days
prior to the date of the hearing. Notice of the telephonic hearing shall be
given to all parties and shall include all necessary telephone numbers.
(2) The appellant is responsible for ensuring the telephone number to the appellant’s location for the telephonic hearing is
accurate and the appellant is available at said telephone number at the time
the hearing is to commence. Failure to
provide the correct telephone number or failure to be available at the commencement
of the hearing shall be treated as a failure to appear and shall subject the
appellant to a default judgment.
(3) The in-person presence of some parties or witnesses at the
hearing shall not prevent the participation of other parties or witnesses by telephone with prior approval of the
hearing examiner.
Q. Recommended action and final
decision:
(1) The
parties may submit briefs including findings of fact and
conclusions of law for consideration by the hearing examiner.
(2) No later than 30 calendar days
after the last submission by a party, the hearing examiner shall prepare and
submit to the secretary a written recommendation of action to be taken by the
secretary. The recommendation shall
propose sustaining, modifying, or reversing the action or
proposed action of the department.
(3) The secretary shall issue a final written decision accepting
or rejecting the hearing examiner’s recommendation in
whole or in part no later than 30 calendar days after receipt of the hearing
examiner’s recommendation. The final
decision shall identify the final action taken.
Service of the secretary’s final decision shall be made upon the
appellant by registered or certified mail.
(4) The final decision or order shall be included in a
producer’s file with the medical cannabis program.
[7.34.4.31 NMAC - Rp, 7.34.4.24
NMAC, 6/23/2020]
7.34.4.32 EXEMPTION FROM STATE CRIMINAL AND CIVIL PENALTIES:
A. No officer,
employee, or approved contractor of a licensed producer, approved manufacturer,
approved courier, or approved laboratory, nor any qualified patient licensed as
a producer or enrolled primary caregiver, shall be
subject to arrest, prosecution, or penalty in any manner for the production,
possession, distribution, or dispensation of cannabis in accordance with this
rule and the act. For the purpose of
this section, the department deems approved
manufacturers, approved couriers, and approved laboratories to be ancillaries
of licensed non-profit producers, entitled to the protections from criminal
liability identified for licensed producers in the Lynn and Erin Compassionate
Use Act, Section 26-2B-4 NMSA 1978.
B. Any property interest that is
possessed, owned, or used in connection with the
production of cannabis or acts incidental to such production shall not be
harmed, neglected, injured, or destroyed while in the possession of state or
local law enforcement officials. Any
such property interest shall not be forfeited under any state or local law
providing for the forfeiture of property except as provided in the Forfeiture
Act. Cannabis, paraphernalia or other
property seized from a qualified patient or primary caregiver in connection
with the claimed medical use of cannabis shall be returned immediately upon the
determination by a court or prosecutor that the qualified patient or primary
caregiver is entitled to the protections of the provisions of this rule and act
as shall be evidenced by a failure to actively investigate the case, a decision
not to prosecute, the dismissal of charges, or acquittal.
C. In
accordance with the Public School Code, Chapter 22 NMSA 1978, and the Lynn and
Erin Compassionate Use Act at Subsection G of Section 26-2B-4 NMSA 1978, the
department hereby deems New Mexico public schools, school districts, local
school boards, locally-chartered charter schools, state-chartered charter
schools, and governing bodies of state-chartered charter schools to be
licensees, and designated school personnel (including designated employees and
volunteers of the foregoing licensees) to be licensee representatives,
authorized within the licensees’ licensure to possess and store cannabis and
cannabis derived products on behalf of qualified students, and to administer
cannabis and cannabis derived products to qualified students, in school
settings. The department deems the
licensees and licensee representatives to be entitled to immunity from arrest,
prosecution or penalty, in any manner, for activities conducted within the
licensees’ licensure and in accordance with the Public School Code.
D. A reciprocal
participant shall not be subject to arrest, prosecution or penalty in any
manner for the
possession of or the medical use of cannabis
if the quantity of cannabis does not exceed the limit identified by
department rule.
[7.34.4.32 NMAC - Rp, 7.34.4.25
NMAC, 6/23/2020]
7.34.4.33 CLOSURE OF A NON-PROFIT PRODUCER
OR AN APPROVED ENTITY: A non-profit producer, manufacturer, laboratory, or courier
that anticipates ceasing its business operations shall notify
the medical cannabis program no later than 30 calendar days prior to
closure. Any such non-profit producer or
approved entity shall post public notice of the anticipated closure in any and
all locations of the producer or approved entity that are accessible to the
public, including but not limited to dispensary locations, at least fourteen
days prior to the closure. Any unused
medical cannabis that is held by a non-profit producer or approved entity on
behalf of another licensee (such as cannabis that is owned by a non-profit
producer and held by a manufacturer) shall be returned to its owner. Cannabis that is otherwise held by a licensee
shall, prior to the licensee’s closure, be surrendered to either state law
enforcement or local law enforcement, destroyed by the licensee in accordance
with the wastage standards of this rule, or donated to patients via a licensed
non-profit producer, and the licensee shall submit documentation of the event to
the department.
[7.34.4.33 NMAC - N, 6/23/2020]
7.34.4.34 PERSONAL PRODUCTION LICENSE CONFIDENTIALITY: Personal
production license holders and applicants:
The department shall maintain a confidential file containing the names, addresses, and telephone numbers of the persons who have
either applied for or received a personal production license (PPL). Individual names of PPL producers and PPL
producer-applicants shall be confidential and not subject to disclosure, except:
A. to
authorized employees or agents of the department as necessary to perform the
duties of the department pursuant to the provisions of this rule and the act;
B. to authorized employees of state or local law enforcement agencies, but only for the purpose of verifying that a person
is lawfully in possession of the license to produce, or as otherwise expressly
permitted in this rule; and
C. as
provided in the federal Health Insurance Portability and Accountability Act of 1996.
[7.34.4.34 NMAC - Rp, 7.34.4.26 NMAC, 6/23/2020]
7.34.4.35 STORAGE AND DISPOSAL OF CANNABIS BY LICENSED
PRODUCERS:
A. Storage: Medical cannabis,
unused cannabis products, and cannabis-derived product waste shall be stored by
a licensed producer in a manner that discourages diversion or theft, until such
time as the material is transferred, disposed of, or destroyed in accordance
with this rule.
B. Disposal
by personal production license holders:
Unused cannabis, cannabis products, or cannabis-derived product waste
that is in the possession of a qualified patient who holds a personal
production license shall be disposed of by transporting the unused portion to a state or local law enforcement office, or by
destruction of the material.
[7.34.4.35 NMAC - Rp, 7.34.4.279
NMAC, 6/23/2020]
7.34.4.36 ASSESSMENT
REPORT: The department shall
evaluate the implementation of the Lynn and Erin Compassionate Use Act and
regulations issued pursuant to that act and provide a report to the secretary
of the department within one year of the effective date of this
regulation. In performing its
evaluation, the department shall focus on whether the needs of qualified
patients are being met by the department’s administration of the act and
whether there is a demonstrable need for a state run production and
distribution facility. The department’s
assessment report shall be issued every two years, shall be a public document,
and shall contain de-identified data upon which the assessment is based.
[7.34.4.36 NMAC - Rp, 7.34.4.28
NMAC, 6/23/2020]
7.34.4.37 SEVERABILITY: If any part or application of these rules is
held to be invalid, the remainder or its application to other situations or persons shall not be affected. Any section of these rules legally severed
shall not interfere with the remaining protections provided by these rules and
the act.
[7.34.4.37 NMAC - Rp, 7.34.4.29
NMAC, 6/23/2020]
HISTORY OF 7.34.4 NMAC:
History of Repealed Material:
7.34.4
NMAC, Licensing Requirements for Producers, Production Facilities and
Distribution (filed 12/01/2008) repealed 12/30/2010.
7.34.4 NMAC, Licensing Requirements for
Producers, Production Facilities and Distribution (filed 12/16/2010) repealed
2/27/2015.
7.34.4 NMAC, Licensing Requirements for
Producers, Production Facilities and Distribution (filed 2/16/2015) repealed 6/23/2020.
NMAC
History:
7.34.4 NMAC, Licensing Requirements for Producers,
Production Facilities and Distribution (filed 12/01/2008) was replaced by
7.34.4 NMAC, Licensing Requirements for Producers, Production Facilities and
Distribution, effective 12/30/2010.
7.34.4 NMAC, Licensing
Requirements for Producers, Production Facilities and Distribution (filed
12/16/2010) was replaced by 7.34.4 NMAC, Licensing Requirements for Producers,
Couriers, Manufacturers and Laboratories, effective 2/27/2015.
7.34.4 NMAC, Licensing
Requirements for Producers, Couriers, Manufacturers and Laboratories (filed 2/16/2015)
was repealed and replaced by 7.34.4 NMAC, Licensing Requirements for Producers,
Couriers, Manufacturers and Laboratories, effective 6/23/2020.