15.03.190 Registered Entities; General Requirements

(a) In addition to other requirements otherwise set forth in this chapter, a registered entity shall comply with the following:

(1) Make its books, records and manufacturing and dispensing facilities available to the Authority 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;

(2) Any deficiencies documented in a statement of findings by the Authority shall require that the registered entity submit a written plan of correction in a format acceptable to the Authority 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 entity 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; and

(E) address any inspection finding which the Authority 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 Authority of the critical deficiency. The Authority 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 entity shall modify the plan until it is accepted by the Authority.

(3) Upon written approval of the Authority, the registered entity shall implement the plan of correction.

(4) Only manufacture and dispense approved medical marijuana products in on Tribal Territory in accordance this chapter;

(5) Only manufacture and dispense approved medical marijuana products in an indoor, enclosed, secure facility located on Tribal Territory which may include greenhouses;

(6) Submit approved medical marijuana product samples and manufacturing materials to the Authority upon request, for but not limited to, quality assurance testing or investigation of an adverse event. A subset of each lot of medical marijuana product shall be retained by the registered entity to allow for testing in the future if requested by the Authority and shall be stored unopened as indicated on the label and in the original packaging. This subset of medical marijuana 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 entity for at least thirty days following the date of expiration.

(7) Implement policies and procedures to notify the Authority within 24 hours of the following:

(A) any adverse events;

(B) any incident involving theft, loss or possible diversion of medical marijuana products;

(C) 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

(D) any vehicle accidents or incidents occurring during transport of medical marijuana products.

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

(9) Quarantine any lot of medical marijuana product as directed by the Authority, and not transport, distribute or dispense such lot unless prior approval is obtained from the Authority;

(10) Dispose of unusable medical marijuana products that have failed laboratory testing or any marijuana used in the manufacturing process pursuant to Subchapter 19;

(11) Maintain records for a period of five (5) years, unless otherwise stated, and make such records available to the Authority upon request. Such records shall include:

(A) documentation, including lot numbers where applicable, of all materials used in the manufacturing of the approved medical marijuana 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;

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

(12) Post the certificate of registration issued by the Authority in a conspicuous location on the premises of each manufacturing facility and dispensing facility.

(b) Registered entities shall not:

(1) Grow marijuana or produce medical marijuana at any site other than a facility or site approved by the Authority and set forth in the registered entity's registration;

(2) Distribute products or samples at no cost except as may be allowed by the Authority;

(3) Make substantial alterations to the structure or architectural design of a manufacturing or dispensing facility without prior written approval of the Authority;

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

(5) 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 Authority;

(6) Locate a dispensing facility on the same street or avenue and within one thousand 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

(7) 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:

(A) managers or employees who come into contact with or handle medical marijuana; and

(B) 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 applicable correction law.

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

(1) The registered entity shall notify the Authority 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 Authority approval in accordance with Authority protocols, and shall include timetables and describe the procedures and actions the registered entity shall take to:

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

(B) properly destroy, transfer or otherwise dispose of all the registered entity's supply of medical marijuana and medical marijuana products;

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

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

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

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

(d) If a registered entity's application for renewal of registration is denied, the registered entity shall submit a proposed plan for closure in accordance with this section.