(1) make its books, records and manufacturing and dispensing facilities available to the department or its authorized representatives for monitoring, on-site inspection, and audit purposes, including but not limited to periodic inspections and/or evaluations of facilities, methods, procedures, materials, staff and equipment to assess compliance with requirements set forth in article 33 of the Public Health Law and this Part;

(2) only manufacture and dispense approved medical marihuana products in New York State in accordance with article 33 of the Public Health Law and this Part;

(3) only manufacture and dispense approved medical marihuana products in an indoor, enclosed, secure facility located in New York State which may include greenhouses;

(4) submit approved medical marihuana product samples and manufacturing materials to the department upon request, for but not limited to, quality assurance testing or investigation of an adverse event. A subset of each lot of medical marihuana product shall be retained by the registered organization to allow for testing in the future if requested by the department and shall be stored unopened as indicated on the label and in the original packaging. This subset of medical marihuana product must be readily identifiable as belonging to its specific lot. The quantity retained shall be a statistically representative number of samples to allow for complete testing of the product at least two times and shall be retained by the registered organization for at least 30 days following the date of expiration;

(5) implement policies and procedures to notify the department within 24 hours of the following:

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

(7) quarantine any lot of medical marihuana product as directed by the department, and not transport, distribute or dispense such lot unless prior approval is obtained from the department;

(8) dispose of unusable medical marihuana products that have failed laboratory testing or any marihuana used in the manufacturing process pursuant to section 1004.24 of this Part;

(9) maintain records required by article 33 of the Public Health Law and this Part for a period of five years unless otherwise stated, and make such records available to the department upon request. Such records shall include:

(10) post the certificate of registration issued by the department in a conspicuous location on the premises of each manufacturing facility and dispensing facility.

(1) dispense approved medical marihuana products from the same location where the marihuana is grown or manufactured;

(2) grow marihuana or produce medical marihuana at any site other than a facility or site approved by the department and set forth in the registered organization’s registration;

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

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

(5) change the composition of the entity which is the registered organization, including but not limited to, a change in sole proprietor, partner, director, stockholder, member or membership interest of the registered organization without the prior written approval of the department;

(6) materially modify or revise its operating plan, including its policies and procedures related to cultivation, processing, manufacturing, distributing or dispensing policies or procedures, without prior written approval of the department;

(7) locate a dispensing facility on the same street or avenue and within 1,000 feet of a building occupied exclusively as a school, church, synagogue or other place 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 facility to the center of the nearest entrance of such school, church, synagogue or other place of worship; or

(8) be managed by or employ anyone who has been convicted of any felony of sale or possession of drugs, narcotics, or controlled substances provided that this provision only applies to:

(1) The registered organization shall notify the department in writing at least 120 days prior to the anticipated date of closure of the manufacturing and each dispensing facility.

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

(3) A registered organization shall take no action to close a manufacturing and dispensing facility prior to department approval of the plan for closure.

(4) A registered organization’s failure to notify the department 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 department to revoke the registration of the registered organization under such terms as the department determines is appropriate based on public health and safety considerations. In addition, the department reserves the right to exercise any other remedies available to it.