DISPENSING ORGANIZATION LICENSE

DISPENSING ORGANIZATION LICENSING

The Texas Department of Public Safety (DPS) announced on January 16, 2023 that its Regulatory Services Division (RSD) is now accepting applications for Compassionate Use Program dispensing organization licenses. 

Compassionate Use Program 

Through the Compassionate Use Program in Texas, authorized under Texas Health and Safety Code, Chapter 487, the DPS operates a secure online registry (Compassionate Use Registry) of qualified physicians who can prescribe low tetrahydrocannabinol (THC) to patients suffering from certain medical conditions. The registry allows a physician to input safety and efficacy data derived from the treatment of patients for whom low-THC cannabis is prescribed. The registry is also accessible to law enforcement agencies and organizations that dispense low-THC cannabis to patients in the Compassionate Use Registry (dispensing organizations), for the purpose of verifying patients. The DPS oversees and manages the licensing of dispensing organizations. 

Dispensing Organization License Application Requirements 

The Application must be completed and submitted by any individual, company, or organization seeking to be licensed to cultivate, process, and dispense low-THC cannabis, and the following documentation must be provided:

1. Proof of ownership and current status of company or organization seeking to dispense low-THC cannabis.
2. Proof of commercial general liability insurance coverage against claims of liability for damage to property of third parties, with limits of: (a) $1,000,000 each occurence; (b) $2,000,000 General Aggregate limit; (c) $1,000,000 Product liability.
3. Proof of ability to secure the premises, resources, and employees necessary to operate as a dispensing organization. 
4. Proof of 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 including floor plans, diversion prevention measures, emergency management plan, etc. 
5. Proof of financial ability to maintain operations for two (2) years from the date of application.
6. Proof of the technical and technological ability to cultivate, process, and/or dispense low-THC cannabis, evidenced by experience in the areas of cultivation, analytical organic chemistry and micro-biology, analytical laboratory methods, patient education and interaction, handling of confidential information, and familiarity with HIPAA.
7. Proof of infrastructure of dispensing facility reasonably located to dispense low-THC cannabis to registered patients. 
8. Project Schedule and Plan including timelines, deliverables, milestones, projected date for filling prescriptions, and plan for provision of statewide coverage for patients. 

How to Apply 

Step One:

1. Download and complete the Dispensing Organization Application Form. 
2. Complete and sign form. 
3. Submit the form to Contact Us through the RSD portal by selecting option “Submit Document(s).” 
4. Enter required information and follow the instructions to attach the completed Application Form using “Add Documents.”

Step Two:

1. Once the form is submitted, an invoice will be sent by RSD via email within 3-5 business days.  The invoice will provide instructions for submitting the application fee in the amount of $7,356 to the Comptroller through a wire transfer.   
2. In addition, a separate email providing login information will be sent by RSD. The email will contain instructions to securely login to submit the required supporting documentation through a secure electronic portal. 
3. The applicant will be required to utilize the secure electronic portal to submit the remaining documentation to complete the application.  

Step Three:

1. RSD will be begin evaluating the application and may contact the applicant with questions or request additional information.  
2. Director, Manager and Employee Registration Applications will not be accepted until after the Dispensing Organization Application window has closed. 
3. Applicants will be contacted by email when the application window for submitting Director, Manager and Employee registrations is open.     

Dispensing Organization License Application Period 

RSD is currently accepting applications for Compassionate Use Program dispensing organization licenses. The application window closes 5pm CT (6pm ET) on April 28, 2023. 

Dispensing Organization Licenses to be Issued 

DPS will only issue the number of licenses necessary to ensure reasonable statewide access to, and availability of, low-THC cannabis for registered compassionate-use patients.

Contact Leaf Legal Now to File Your Application 

The medical cannabis space is highly-regulated. To succeed, it is a must for companies to obtain the licenses and insurance necessary to operate legally. Leaf Legal, P.C. is fully equipped to guide your company as it obtains licenses, permits, identifies and recruits top talent, executes its business plan, and navigates Texas's emerging regulatory scheme. Contact the attorneys at Leaf Legal, P.C. to request a consultation.