| (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.
(c) Subsequent to the submission of all information
and documentation required by subsection (b)(1) - (6) of this section
and the conditional approval of the application, the department will
conduct an onsite inspection to confirm applicant's compliance with
the requirements of subsection (b)(7) of this section and of this
chapter generally. The applicant must pass the inspection prior to
licensure. Failure to pass the inspection will result in notification
of the basis for the failure. Failure to address the basis for the
failure within sixty (60) days of notice may result in the denial
of the application, pursuant to §12.15 of this title (relating
to Denial of Application for License). Upon request of the applicant,
the department may extend the period to address the basis for the
failure for one (1) additional thirty (30) day period.
(d) Failure of an applicant to submit all information
and documentation required by subsection (b)(1) - (6) of this section
will result in notification of the deficiency. Applicant will have
ninety (90) days from the date of notice to address the deficiency.
Upon request of the applicant, the department may extend the period
to address the deficiency for one (1) additional ninety (90) day period.
If an applicant fails to provide all required application materials,
or fails to respond to a request by the department for additional
information necessary to process the application, the application
will be terminated. Following the termination of an application, a
new application, including a new application fee, must be submitted.
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