New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle B - Division of Alcoholic Beverage Control › Chapter II - Rules of the Office of Cannabis Management › Part 113 - Medical Cannabis › Section 113.11 - Registered Organizations; General Requirements

Current through Register Vol. 46, No. 28, July 10, 2024
(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.