Current through Register Vol. 34, No. 24, December 19, 2023
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
paidby 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, 12/30/2010, Amended by
New
Mexico Register, Volume XXVI, Issue 04, February 27, 2015, eff.
2/27/2015, Amended by
New
Mexico Register, Volume XXVII, Issue 04, February 29, 2016, eff.
2/29/2016, Amended
by
New
Mexico Register, Volume XXX, Issue 06, March 26, 2019, eff.
3/1/2019, Amended by
New
Mexico Register, Volume XXX, Issue 16, August 27, 2019, eff.
8/27/2019, Adopted
by
New
Mexico Register, Volume XXXI, Issue 12, June 23, 2020, eff.
6/23/2020