Texas Administrative Code › Title 37 - PUBLIC SAFETY AND CORRECTIONS › Part 1 - TEXAS DEPARTMENT OF PUBLIC SAFETY › Chapter 12 - COMPASSIONATE-USE/LOW-THC CANNABIS PROGRAM › Subchapter B - APPLICATION AND RENEWAL › Section 12.11 - Application for License

Current through Reg. 49, No. 28; July 12, 2024
(a) Application for
				  license as a dispensing organization may only be made in the manner determined
				  by the department .
(b) A complete
				  application must include the items detailed in this subsection, in a manner
				  determined by the department:
(1) Proof of
				  ownership and current status in the manner required by the department,
				  including but not limited to a current Certificate of Existence or Certificate
				  of Authority from the Texas Office of the Secretary of State and a Certificate
				  of Good Standing from the Texas Comptroller of Public Accounts;
(2) All application fees required under
				  §
											12.14
				  of this title (relating to Application and Licensing Fees and Method of
				  Payment);
(3) Names, dates of
				  birth, addresses, and all other information required by the department
				  necessary to verify the identity of all directors, managers, and employees of
				  the applicant;
(4) Criminal history
				  disclosure of all convictions and deferred adjudications for each individual
				  listed on the application as directors, managers, and employees of the
				  dispensing organization;
(5)
				  Complete registration applications for all directors, managers and employees
				  submitted in the manner approved by the department and in compliance with
				  §
											12.12
				  of this title (relating to Application for Registration);
(6) Proof of commercial general liability
				  insurance coverage against claims of liability for damage to property of third
				  parties and for personal injuries to third parties, including bodily injury,
				  property damage, and product liability, with limits of:
(A) $1,000,000 each occurrence;
(B) $2,000,000 General Aggregate limit; and
(C) $1,000,000 Product
				  Liability.
(7) Evidence
				  of the qualifications detailed in this paragraph as determined at the time of
				  the required onsite inspection, in the manner determined by the department:
(A) The technical and technological ability
				  to cultivate, process, and/or dispense low-THC cannabis, evidenced by
				  experience in the areas of:
(i) Cultivation,
				  analytical organic chemistry and micro-biology; and analytical laboratory
				  methods; and
(ii) Patient education
				  and interaction, and the handling of confidential information including
				  familiarity with the requirements of the Health Insurance Portability and
				  Accountability Act (HIPAA).
(B) The ability to secure the premises,
				  resources, and employees necessary to operate as a dispensing organization,
				  evidenced by:
(i) Descriptions of all
				  properties applicant proposes to utilize to cultivate, process, and dispense
				  low-THC cannabis, including ownership information for the properties;
(ii) Descriptions of the methods proposed for
				  the cultivation, processing, and dispensing of low-THC cannabis;
(iii) Descriptions of the types and locations
				  of worker safety equipment and plans and procedures for complying with federal
				  Occupational Safety and Health Administration (OSHA) regulations for workplace
				  safety;
(iv) A list of current and
				  proposed staff, including, position, duties and responsibilities, and an
				  organizational chart illustrating the supervisory structure of the dispensing
				  organization;
(v) Description of
				  the applicant's proposed testing laboratory, and description of the proposed
				  testing protocols and methods;
(vi)
				  A proposal establishing the ability to secure premises reasonably located to
				  allow patient access through existing infrastructure; and
(vii) Department approved acknowledgments
				  executed by the applicant's directors, managers and employees indicating
				  familiarity with the federal laws governing marijuana and its interstate
				  transportation.
(C) The
				  ability to maintain accountability of all raw materials, finished products, and
				  any by-products to prevent diversion or unlawful access to or possession of
				  these substances, evidenced by:
(i) Floor
				  plan of each facility or proposed floor plans for proposed facilities,
				  including:
(I) Locking options for all means
				  of ingress and egress consistent with life safety requirements;
(II) Alarm systems;
(III) Video surveillance;
(IV) Name, layout and function of each room;
				  and
(V) Storage, including safes
				  and vaults.
(ii)
				  Diversion prevention procedures;
(iii) Emergency management plan;
(iv) System for tracking source plant
				  material throughout cultivation, processing, and dispensing;
(v) Inventory control system as required by
				  §
													12.8 of
				  this title (relating to Inventory Control System);
(vi) Policies and procedures for
				  recordkeeping;
(vii) Electronic
				  vehicle tracking systems;
(viii)
				  Vehicle security systems;
(ix)
				  Methods of screening and monitoring employees;
(x) Employee qualifications and experience
				  with chain of custody or other tracking mechanisms;
(xi) Waste disposal plan;
(xii) Recall procedures for any product that
				  has a reasonable probability of causing adverse health consequences based on a
				  testing result, patient reaction, or other reason; and
(xiii) Access to specialized resources or
				  expertise regarding data collection, security, and tracking.
(D) Infrastructure reasonably
				  located to dispense low-THC cannabis to registered patients, evidenced by:
(i) Map showing the location of the
				  applicant's proposed dispensing facilities with streets; property lines;
				  buildings; parking areas; outdoor areas, if applicable; fences; security
				  features; fire hydrants, if applicable; and access to water and sanitation
				  systems;
(ii) Floor plan of the
				  actual or proposed building or buildings where dispensing activities will occur
				  showing areas designed to protect patient privacy and areas designed for retail
				  sales, with proposed hours of operation;
(iii) HIPAA compliant computer network
				  utilized by all facilities;
(iv)
				  Identifying descriptions of any vehicles to be used to transport product;
				  and
(v) Description of all
				  communication systems.
(E) The financial ability to maintain
				  operations for two (2) years from the date of application, evidenced by:
(i) Applicant's business organization, and
				  corporate structure if applicable;
(ii) List of all owners of any non-corporate
				  applicant, or all shareholders of a corporate applicant;
(iii) All individuals and entities with
				  control over the applicant;
(iv)
				  Projected two (2) year budget; and
(v) Description of available assets
				  sufficient to support the dispensing organization activities.