N.Y. Comp. Codes R. & Regs. tit. 9 § 113.11

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

Section 113.11 - Registered Organizations; General Requirements

(a) In addition to the requirements in Cannabis Law and as otherwise set forth in this Part, a registered organization shall:

(1) make its books, records, manufacturing and dispensing site architectural and engineering design drawings, including a description of energy sources, type and location of engineering systems in use for heating, cooling, ventilation and electrical distribution, water supply and sewage, policies and procedures, and manufacturing and dispensing sites, available to the Office or its authorized representatives within 48 hours of notice for monitoring, on-site inspection, and audit purposes, including but not limited to periodic inspections or evaluations of facilities, methods, procedures, materials, staff and equipment to assess compliance with requirements set forth in Article 3 of the Cannabis Law and this Part. The operating plan must be onsite and readily accessible at each facility at all times;

(2) only manufacture and dispense medical cannabis products in New York State in accordance with Article 3 of the Cannabis Law and this Part;

(3) only dispense medical cannabis products in an indoor, enclosed, secure facility located in New York State;

(4) submit medical cannabis product(s), samples and manufacturing materials to the Office upon request;

(5) retain a subset of each lot of medical cannabis product to allow for testing in the future if requested by the Office. The retained samples shall:

(i) be stored unopened as indicated on the label and in the original packaging;

(ii) be readily identifiable as belonging to its specific lot; and

(iii) be a statistically representative quantity to allow for complete testing of the product at least two (2) times and shall be retained by the registered organization for at least thirty (30) days following the date of expiration.

(6) implement policies and procedures to notify the Office within twenty-four (24) hours of the following:

(i) any serious adverse events;

(ii) any incident involving theft, loss or possible diversion of medical cannabis products;

(iii) any suspected or known security breach or other facility event that may compromise public health and/or safety, or which requires response by public safety personnel or law enforcement; and

(iv) any vehicle accidents or incidents occurring during transport of medical cannabis products; and

(7) within ten (10) days of the occurrence of one of the above events, the registered organization shall submit a complete written incident report to the Office detailing the circumstances of the event, any corrective actions taken, and where applicable, confirmation that appropriate law enforcement authorities were notified.

(8) quarantine any lot of medical cannabis product as directed by the Office, and not transport, distribute, dispense or destroy such lot unless prior approval is obtained from the Office;

(9) dispose of unusable medical cannabis products that have failed laboratory testing or any cannabis used in the manufacturing process pursuant to section 113.25 of this Part;

(10) maintain records required by Article 3 of the Cannabis Law and this Part for a period of five (5) years, unless otherwise stated, and make such records available to the Office upon request. Such records shall include:

(i) documentation, including lot numbers where applicable, of all materials used in the manufacturing of the medical cannabis product to allow tracking of the materials, including but not limited to, soil, soil amendment, nutrients, hydroponic materials, fertilizers, growth promoters, pesticides, fungicides, and herbicides;

(ii) cultivation, manufacturing, packaging and labeling production records; and

(iii) laboratory testing results.

(11) post the certificate of registration issued by the Office in a conspicuous location on the premises of each manufacturing facility and dispensing site;

(12) amend its operating plan as directed by the Office;

(13) provide all employees with adequate training and proper safety equipment where necessary; and

(14) implement procedures to notify the Office if the dispensing site closes during its normal hours of operation, the reason for the closure, and when the dispensing site is expected to resume normal hours of operation.

(b) Registered organizations shall not:

(1) dispense medical cannabis products from the same location where the cannabis is grown or manufactured, except for the operation of home delivery services;

(2) grow cannabis or produce medical cannabis at any site other than a facility or site approved by the Office as set forth in the registered organization's registration;

(3) distribute products or samples at no cost except as may be allowed by the Office;

(4) make substantial alterations to the structure or architectural design of a manufacturing or dispensing site without prior written approval of the Office;

(5) make the following modifications to a registered facility:

(i) change the location without prior approval of the Board; or

(ii) expand or reduce the size of a registered facility without prior written approval of the Office;

(6) materially modify or revise its operating plan, including its policies and procedures, without filing the revised operating plan in a manner as prescribed by the Office;

(7) locate a dispensing site on the same street or avenue and within five hundred (500) feet of school grounds as such term is defined in the Education Law or two hundred (200) feet from a house of worship. The measurements in this paragraph of this subdivision are to be taken in straight lines from the center of the nearest entrance of the premises sought to be used as a dispensing site used by certified patients or designated caregivers to enter to the nearest point of the school grounds or house of worship; or

(8) change the name of the registered organization, including the name by which the organization does business, without receipt of prior written approval of the Office.

(c) In the event that a registered organization elects to cease operation of all permitted activities and surrender its registration, the registered organization shall:

(1) notify the Office in writing at least 120 days prior to the anticipated date of closure of the manufacturing and each dispensing site.

(2) include a proposed plan for closure in the written notice. The plan shall be subject to Office approval in accordance with Office protocols, and shall include timetables and describe the procedures and actions the registered organization shall take to:

(i) notify affected certified patients and designated caregivers of the closure;

(ii) properly destroy, transfer or otherwise dispose of all the registered organization's supply of cannabis and medical cannabis products in accordance with the requirements set forth in section 113.25 of this Part;

(iii) maintain and make available to the Office all records required to be maintained under this Part for a period of five (5) years; and

(iv) maintain compliance with these regulations and any other conditions required by the Office until the approved closure date;

(3) The registered organization shall take no action to close a manufacturing or dispensing site prior to Office approval of the plan for closure; and

(4) The registered organization's failure to notify the Office of intent to cease any operations, failure to submit an approvable plan, and/or to execute the approved plan may result in the imposition of civil penalties, not to exceed $2,000, and shall be a basis for the Board to revoke the registration of the registered organization under such terms as the Board determines is appropriate based on public health and safety considerations. In addition, the Office reserves the right to exercise any other remedies available to it.

N.Y. Comp. Codes R. & Regs. Tit. 9 § 113.11

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