Current through Register Vol. 46, No. 12, March 20, 2024
(b) In order to operate as a registered
organization, an entity shall file an application on forms or in a manner
prescribed by the commissioner. The application shall be signed by the chief
executive officer duly authorized by the board of a corporate applicant, or a
general partner or owner of a proprietary applicant. The application shall set
forth or be accompanied by the following:
(1)
the name, address, phone and email address of the applicant;
(2) identification of all real property,
buildings and facilities that will be used in manufacturing, as defined in
section
1004.11
of this Part, and dispensing of the medical marihuana products;
(3) identification of all equipment that will
be used to carry out the manufacturing, processing, transportation, distributing,
sale and dispensing activities described in the application and operating
plan;
(4) an operating plan that
includes a detailed description of the applicant's manufacturing processes,
transporting, distributing, sale and dispensing policies or procedures. The
operating plan shall also include:
(i) a
detailed description of any devices used with approved medical marihuana products
to be offered or sold by the registered organization;
(ii) policies and procedures related to
security and control measures that will be in place to prevent diversion, abuse,
and other illegal or unauthorized conduct relating to medical marihuana and are
consistent with provisions set forth in this Part;
(iii) a standard operating procedure manual for
all methods used from cultivation of the medical marihuana through packaging,
sealing and labeling of each lot of medical marihuana product. The procedures
shall include use of good agricultural practices (GAPs) and must conform to all
applicable laws and rules of New York State. Standard operating procedures shall
be able to be validated to demonstrate that the applicant will be able to produce
and dispense consistent and reproducible medical marihuana product such that, for
each form of each brand produced, there is homogeneity, absence of contamination
and reproducibility of the brand profile in each lot as defined in section
1004.11
of this Part;
(iv) quality assurance
plans, including but not limited to plans to detect, identify and prevent
dispensing errors;
(v) policies and
procedures to document and investigate approved medical marihuana product
returns, complaints and adverse events, and to provide for rapid voluntary or
involuntary recalls of any lot of medical marihuana product. Such policies and
procedures shall include a plan for any retesting of returned approved medical
marihuana products, storage and disposal of marihuana and any manufactured
medical marihuana products not passing requirements, and a requirement that
adverse events and total recalls are reported to the department within 24 hours
of their occurrence;
(vi) a quality
assurance program to track contamination incidents and document the investigated
source of such incidents, and the appropriate corrective action(s)
taken.
(vii) detailed description of
plans, procedures and systems adopted and maintained for tracking, recordkeeping,
record retention and surveillance systems, relating to all medical marihuana at
every stage including cultivating, possessing of marihuana, and manufacturing,
delivery, transporting, distributing, sale and dispensing by the proposed
registered organization.
(viii)
proposed hours of operation for the manufacturing and dispensing
facilities;
(5) copies of
the organizational and operational documents of the applicant, including but not
limited to, as applicable: the certificate of incorporation, bylaws, articles of
organization, partnership agreement, operating agreement and other applicable
documents and agreements, and all amendments thereto;
(6) the name, residence address and title of
each of the board members, officers, managers, owners, partners, principal
stakeholders, directors and any person or entity that is a member of the
applicant. Each such person (if an individual, or lawful representative, if a
legal entity) shall submit an affidavit with the application setting forth:
(i) any position of management or ownership
during the preceding 10 years of a 10 percent or greater interest in any other
business, located in or outside New York State, manufacturing or distributing
drugs; and
(ii) whether such person
or any such business has been convicted of a felony or had a registration or
license suspended or revoked in any administrative or judicial proceeding. In
addition, any managers who may come in contact with or handle medical marihuana,
including medical marihuana products, shall be subject to a fingerprinting
process as part of a criminal history background check in compliance with the
procedures established by Division of Criminal Justice Services and submission of
the applicable fee;
(7)
documentation that the applicant has entered into a labor peace agreement, as
required by subdivision 1 of section
3365 of the Public Health Law, with a
bona-fide labor organization that is actively engaged in representing or
attempting to represent the applicant's employees. The maintenance of such a
labor peace agreement shall be an ongoing material condition of
registration;
(8) a statement that
the applicant is able to comply with all applicable State and local laws and
regulations relating to the activities in which it intends to engage under the
registration;
(9) copies of all
applicable executed and proposed deeds, leases, and rental agreements or executed
option contracts related to the organization's real property interests, that
shows that the applicant possesses or has the right to use sufficient land,
buildings, and other premises as specified in the application and equipment to
properly carry on the activities for which registration is sought. In the
alternative, the applicant shall post a bond of not less than $2,000,000;
provided, however, that if the applicant posts a bond in lieu of providing the
documentation requested herein, the applicant's submission of the applicable
executed deeds, leases and rental agreements shall be required prior to the
issuance of a registration to the applicant, if selected; and, provided further
that whenever any applicant proposes to lease premises for the activities
described in its operating plan, the lease agreement shall clearly set forth as a
purpose the manufacturing and/or dispensing of medical marihuana, as applicable,
and include the following language:
"The landlord acknowledges that its rights of reentry into the
premises set forth in this lease do not confer on it the authority to manufacture
and/or dispense on the premises medical marihuana in accordance with article 33
of the Public Health Law and agrees to provide the New York State Department of
Health, Mayor Erastus Corning 2nd Tower, The Governor Nelson A. Rockefeller
Empire State Plaza, Albany, N.Y. 12237, with notification by certified mail of
its intent to reenter the premises or to initiate dispossess proceedings or that
the lease is due to expire, at least 30 days prior to the date on which the
landlord intends to exercise a right of reentry or to initiate such proceedings
or at least 60 days before expiration of the lease."
(10) a financial statement setting forth all
elements and details of any business transactions connected with the application,
including but not limited to all agreements and contracts for consultation and/or
arranging for the assistance in preparing the application;
(11) architectural program and sketches of the
applicant's proposed manufacturing and dispensing facility(ies) including the
following:
(i) site plans;
(ii) schematic architectural and engineering
design drawings and single line sketches in an appropriate scale showing the
relationship of various buildings to each other, room configurations, major exit
corridors, exit stair locations, and circulation along with existing buildings if
additions or alterations are part of the project;
(iii) outline specifications for the type of
construction proposed including a description of energy sources, type and
location of engineering systems proposed for heating, cooling, ventilation and
electrical distribution, water supply and sewage;
(iv) a security plan indicating how the
applicant will comply with the requirements of article 33 of the Public Health
Law, this Part and any other applicable law, rule, or regulation; and
(v) the registered organization shall submit
detailed floor plans indicating the activities performed in each area and
security plans (physical and cyber) consistent with the requirements of section
1004.13
of this Part;
(12) a
construction timetable;
(13) a
statement as to whether the applicant, any controlling person of the applicant,
any manager, any sole proprietor applicant, any general partner of a partnership
applicant, any officer and member of the board of directors of a corporate
applicant, and corporate general partner had a prior discharge in bankruptcy or
was found insolvent in any court action;
(14) if any controlling person of the
applicant, any manager, any sole proprietor applicant, any general partner of a
partnership applicant, any officer and member of the board of directors of a
corporate applicant, or corporate general partner or a combination of such
persons collectively, maintains a 10 percent interest or greater in any firm,
association, foundation, trust, partnership, corporation, or other entity or if
such entity maintains a 10 percent interest or greater in the applicant, and such
entity will or may provide goods, leases, or services to the registered
organization, the value of which is or would be $500 or more within any one year,
the name and address of the entity shall be disclosed together with a description
of the goods, leases or services and the probable or anticipated cost to the
registered organization;
(15) if the
applicant is a corporate subsidiary or affiliate of another corporation,
disclosure of the parent or affiliate corporation including the name and address
of the parent or affiliate, the primary activities of the parent or affiliate,
the interest in the applicant held by the parent or affiliate and the extent to
which the parent will be responsible for the financial and contractual
obligations of the subsidiary;
(16)
the most recent certified financial statement of the applicant, audited by an
independent certified public accountant and prepared in accordance with generally
accepted accounting principles (GAAP) applied on a consistent basis, including a
balance sheet as of the end of the applicant's last fiscal year and income
statements for the past two fiscal years, or such shorter period of time as the
applicant has been in operation;
(17)
if construction, lease, rental or purchase of the manufacturing or dispensing
facility has not been completed, a statement indicating the anticipated source
and application of the funds to be used in such purchase, lease, rental or
construction;
(18) a staffing plan
for staff involved in activities related to the cultivation of marihuana, the
manufacturing and/or dispensing of approved medical marihuana products and/or
staff with oversight responsibilities for such activities, which shall include:
(i) a senior staff member with a minimum of one
year experience in good agricultural practices (GAP);
(ii) a quality assurance officer who shall
exercise oversight of the organization's practices and procedures and who has
documented training and experience in quality assurance and quality control
procedures;
(iii) a requirement that
all staff be 21 years of age or older;
(iv) a requirement that all staff involved in
the manufacturing be trained in and conform to general sanitary practices;
and
(v) policies and procedures to
ensure that the proposed registered organization shall not employ anyone who
would come in contact with or handle medical marihuana who has been convicted of
any felony of sale or possession of drugs, narcotics, or controlled substances in
accordance with the requirements of section
3364 of the Public Health Law.
(19) any other information as may be
required by the commissioner.