N.Y. Comp. Codes R. & Regs. tit. 10 § 1004.10

Current through Register Vol. 46, No. 45, November 2, 2024

Section 1004.10 - Registered organizations; general requirements

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

(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;

(i) Any deficiencies documented in a statement of findings by the department shall require that the registered organization submit a written plan of correction in a format acceptable to the department within 15 calendar days of the issue date of the statement of findings. A plan of correction shall address all deficiencies or areas of noncompliance cited in the statement of findings and shall:

(a) contain an assessment and analysis of the events and/or circumstances that led to the noncompliance;

(b) contain a procedure addressing how the registered organization intends to correct each area of noncompliance;

(c) contain an explanation of how proposed corrective actions will be implemented and maintained to ensure noncompliance does not recur;

(d) contain the proposed date by which each area of noncompliance shall be corrected;

(e) address any inspection finding which the department determines jeopardizes the immediate health, safety, or well-being of certified patients, designated caregivers or the public. Such a finding shall be deemed a critical deficiency and shall require immediate corrective action to remove the immediate risk, followed by the submission of a corrective action plan within 24 hours of notification by the department of the critical deficiency. The department will acknowledge receipt within 24 hours and respond as soon as practicable to notify if the plan is accepted or needs modification. If the corrective action plan needs modification, the registered organization shall modify the plan until it is accepted by the department.

(ii) Upon written approval of the department, the registered organization shall implement the plan of correction.

(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 thirty days following the date of expiration;

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

(i) any adverse events;

(ii) any incident involving theft, loss or possible diversion of medical marihuana 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 marihuana products.

(6) Within ten 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 processpursuant 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:

(i) documentation, including lot numbers where applicable, of all materials used in the manufacturing of the approved medical marihuana 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.

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

(b) Registered organizations shall not:

(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:

(i) managers or employees who come into contact with or handle medical marihuana; and

(ii) a conviction less than ten years (not counting time spent in incarceration) prior to being employed, for which the person has not received a certificate of relief from disabilities or a certificate of good conduct under article 23 of the correction law.

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

(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:

(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 medical marihuana and medical marihuana products;

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

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

(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.

(d) 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 this section.

N.Y. Comp. Codes R. & Regs. Tit. 10 § 1004.10

Adopted, New York State Register April 15, 2015/Volume XXXVII, Issue 15, eff. 4/15/2015

Amended New York State Register December 27, 2017 /Volume XXXIX, Issue 52, eff. 12/27/2017