New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter XIII - Medical Use of Marihuana › Part 1004 - Medical Use of Marihuana › Section 1004.5 - Application for initial registration as a registered organization

Current through Register Vol. 46, No. 28, July 10, 2024
(a) No person or
				entity shall produce, grow or sell medical marihuana or hold itself out as a
				New York State registered organization unless it has complied with article 33
				of the Public Health Law and this Part and is registered by the
				department.
(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.