N.Y. Comp. Codes R. & Regs. tit. 9 § 113.8

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

Section 113.8 - Applications for Renewal of Registration as Registered Organization

(a) An application to renew any registration issued under this Part shall be filed with the Office not more than six (6) months nor less than four (4) months prior to the expiration thereof. If a renewal application is not filed at least four (4) months prior to the expiration thereof, the Board may determine that the registration shall have expired and become void on such expiration date.

(b) Applications shall be accompanied by a non-refundable application fee and a registration fee as set forth in section 113.7 of this Part, made by certified check. Only applications completed in accordance with this Part as determined by the Board and for which the application and registration fees have been submitted shall be considered if submitted in a timely manner. The registration fee shall be returned to the registered organization applicant if the registered organization applicant is not granted a renewal registration under this section.

(c) The application for renewal shall include such information prepared in the manner and detail as the Board may require, including but not limited to:

(1) any material change(s) as determined by the Office in the information, circumstances or factors listed in section 113.6 of this Part;

(2) every known complaint, charge or investigation, pending or concluded during the period of the registration, by any governmental or administrative agency with respect to:

(i) each incident or alleged incidence involving the theft, loss, or possible diversion of medical cannabis manufactured, distributed, or dispensed by the registered organization; and

(ii) compliance by the registered organization applicant with local or state laws, or regulations of the Board, including but not limited to, with respect to any controlled substance listed in section 3306 of the Public Health Law; and

(3) information concerning the registered organization applicant's ability to carry on the activity for which it is registered, including but not limited to, medical cannabis product shortages or wait lists occurring during the registration period;

(4) a summary of quality assurance testing for all medical cannabis products produced in the prior year, including but not limited to, the percentage of lots of each product passing all required testing, the percentage of lots failing contaminant testing, the percentage of lots failing product requirements, all recalls of product lots and all adverse events reported; and

(5) an updated environmental sustainability packaging program plan and a report of key metrics including, but not limited to, the total amount of packaging material, by weight, sold, offered for sale, or distributed into the state by the registered organization during the renewal period and the total costs of packaging material.

(d) The Board shall consider applications for renewal in accordance with the criteria set forth in section 113.7 of this Part.

(e) If the Board determines that the registered organization applicant's registration should not be renewed, the Board shall serve upon the registered organization applicant or their attorney of record, in person or by registered or certified mail, an order directing the registered organization applicant to show cause why their application for renewal should not be denied. The order shall specify in detail the ways in which the registered organization applicant has not satisfied the requirements for renewal.

(1) Within ten (10) business days of receipt of such an order, the registered organization applicant may submit additional material to the Board or demand a hearing, or both. If a hearing is demanded, the Board shall fix a date as soon as reasonably practicable.

(2) If the registered organization applicant fails to submit additional material to the Board within ten (10) business days as requested, and the registered organization applicant does not demand a hearing within such time period, the application for renewal of registration shall be denied.

(f) If a registered organization's application for renewal of registration is denied, the registered organization shall submit a proposed plan for closure in accordance with subdivision (c) paragraph (2) of section 113.11 of this Part.

N.Y. Comp. Codes R. & Regs. Tit. 9 § 113.8

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