N.Y. Comp. Codes R. & Regs. tit. 9 § 113.7

Current through Register Vol. 46, No. 36, September 4, 2024

Section 113.7 - Consideration of Registered Organization Applications

(a) Registered organization applicants for approval to operate as registered organizations shall submit an application to the Office, containing the information required in section 113.6 of this Part, in a manner and format determined by the Board.

(b) Applications, as well as renewal applications, shall be accompanied by a non-refundable application fee in the amount of $10,000 unless the Board determines otherwise due to the nature and scope, or size of the activities for which the registered organization is applying.

(c) The registration fee for the registration period, as well as any renewal registration period, shall be $200,000, unless the Board determines otherwise due to the nature and scope, or size of the activities for which the registered organization is applying.

(d) Registered organization applicants granted a registration shall immediately submit the registration fee by certified check, or another method approved by the Board.

(e) In deciding whether to grant an application for registration or amendment to a registration, the Board shall consider whether:

(1) the registered organization applicant will be able to manufacture medical cannabis products, each with a consistent phytocannabinoid profile (the concentration of total tetrahydrocannabinol (THC) and total cannabidiol (CBD) will define the product) and each able to pass the required quality control testing;

(2) the registered organization applicant will produce sufficient quantities of medical cannabis products as necessary to meet the needs of certified patients;

(3) the registered organization applicant will be able to maintain effective control against diversion of cannabis, medical cannabis, and medical cannabis products;

(4) the registered organization applicant is able to comply with all applicable state and local laws and regulations;

(5) the registered organization applicant is ready, willing and able to properly carry on the activities set forth in this Part;

(6) the registered organization applicant possesses or has the right to use sufficient real property, buildings and equipment to properly carry on the activity described in its operating plan;

(7) it is in the public interest that such registration be granted including:

(i) whether the number of registered organizations in an area will be adequate to reasonably serve the area, including whether there is sufficient geographic distribution across the state;

(ii) whether the registered organization applicant is a minority owned business, woman owned business enterprise (or both), a service-disabled veteran-owned business, or from communities disproportionately impacted as those terms are defined in section 87 of the Cannabis Law and as determined by the Board;

(iii) whether the registered organization provides education and outreach to practitioners;

(iv) whether the registered organization promotes the research and development of medical cannabis and patient outreach;

(v) the affordability of medical cannabis products offered by the registered organization;

(vi) whether the registered organization is culturally, linguistically, and medically competent to provide services to unserved and underserved areas;

(vii) whether the registered organization is reflective of the demographics of the state, and representative of communities disproportionately impacted by cannabis prohibition;

(viii) whether the registered organization promotes racial, ethnic and gender diversity in their workforce; and

(ix) whether the registered organization minimizes or eliminates adverse environmental impacts, including but not limited to water energy and water usage, carbon emissions, waste, pollutants, and single-use plastics, and complies with the energy and environmental regulations set forth in section 113.26 of this Part;

(8) the board members, officers, managers, owners, partners, principal stakeholders, directors, and members of the applicant's organization are of good moral character and competent to perform the duties of a registrant, including but not limited to consideration of any enforcement action or investigation against any of these individuals or related entities in another jurisdiction;

(9) the registered organization applicant has entered into a labor peace agreement with a bona-fide labor organization, as defined in Article 1 of the Cannabis Law, that is actively engaged in representing or attempting to represent the registered organization applicant's employees;

(10) upon evaluation, the registered organization applicant's proposed business plan and proposed manufacturing and dispensing sites, including but not limited to the location and construction timeline for the proposed facilities are found to be suitable to meet the needs of the program; and

(11) the registered organization applicant and its board members, officers, managers, owners, partners, principal stakeholders, directors, and members of the applicant's organization have any history of administrative violations or disciplinary actions taken against them by any regulatory or licensing authority in any jurisdiction during the past five (5) years.

(f) The registered organization applicant shall allow reasonable access to the Office or its authorized representatives for the purpose of conducting an on-site survey or inspection of the applicant's proposed manufacturing or dispensing sites.

(g) If the Office is not satisfied that the registered organization applicant should be issued a registration, the Office shall notify the registered organization applicant in writing of those factors upon which further evidence is required. Within thirty (30) days of the receipt of such notification, the applicant may submit additional material to the Office or demand a hearing, or both.

(h) Upon application to the Board, a registered organization's registration may be amended to allow the registered organization to relocate within the state or to add or delete permitted registered organization activities or facilities. The Board shall consider whether to grant or deny the application for amendment of the registration utilizing the criteria set forth in subdivision (e) of this section. The fee for such amendment review shall be $2,000. A registered organization may apply to add an additional four dispensing sites; provided that:

(1) the registered organization's first four dispensing sites are operational;

(2) the first two additional dispensing sites shall be located in underserved or unserved geographic locations, as determined by the Board, and shall be operational before consideration will be given for the remaining two dispensing sites; and

(3) a fee is received for each new dispensing facility application of $2,000.

(i) Registrations issued shall be valid for two (2) years from the date of issuance.

N.Y. Comp. Codes R. & Regs. Tit. 9 § 113.7

Adopted New York State Register February 22, 2023/Volume XLV, Issue 08, eff. 2/22/2023