Fla. Admin. Code R. 64ER24-1

Current through Reg. 50, No. 235-239, December 10, 2024

Section 64ER24-1 - MMTC Seed-to-Sale Tracking System Integration

(1) For purposes of this rule, the following definitions apply:

(a) "Department STS Tracking System" means the computer software seed-to-sale (STS) tracking system established, maintained, and controlled by the department pursuant to s. 381.986(8)(d), F.S.

(b) "Internal STS Tracking System" means an MMTC's own computer software seed-to-sale tracking system.

(c) "Unique product ID" means a unique combination of letters, numbers, or special characters selected by an MMTC and assigned to each type of usable product and marijuana delivery device made available to qualified patients. Usable products of the same cultivar, size, volume, flavor, ratio of tetrahydrocannabinol to cannabidiol, and route of administration shall be considered a single product type for purposes of assigning a unique product ID. The stock-keeping unit (SKU) number assigned to an MMTC's usable product or marijuana delivery device may also serve as the unique product ID so long as the SKU number is unique to each product type and marijuana delivery device.

(2) An MMTC must use an Internal STS Tracking System that fully integrates with the Department STS Tracking System. An Internal STS Tracking System is deemed fully integrated with the Department STS Tracking System when it successfully connects to and communicates with the Department STS Tracking System in real time. This connection will be established through an application programming interface (API).

(3) Prior to full integration with the Department STS Tracking System, each MMTC must attend three department-facilitated training sessions with the Department's STS Tracking System Vendor. Each MMTC must also submit a written integration plan to the department, all in accordance with the following schedule.

(a) An MMTC that is licensed by the department as of the effective date of this rule shall:

1. Attend its first training session within 45 calendar days from the effective date of this rule;

2. Submit a written integration plan to the department within 30 calendar days after the date of its first training session;

3. Attend its second training session within 15 calendar days after the date of its submission of a written integration plan to the department; and

4. Attend its third training session within 15 calendar days after the date of its second training session.

(b) An MMTC that is licensed after the effective date of this rule shall attend three training sessions and submit a written integration plan such that the MMTC achieves full integration with the Department STS Tracking System before obtaining cultivation authorization from the department.

(4) The written integration plan required in subsection (3) must detail the process for fully integrating the MMTC's Internal STS Tracking System with the Department STS Tracking System.

(a) The written integration plan must be submitted to the department for approval via email at ommu_seedtosale@flhealth.gov. The department will send written notice to the MMTC either approving the written integration plan, requesting additional information, or requiring changes to the plan.

(b) The written integration plan must include, without limitation, the following information:

1. Name, phone number, and email address of the MMTC's contact person with primary responsibility for integrating the Internal STS Tracking System with the Department STS Tracking System;

2. Name of the Internal STS Tracking System;

3. Key date milestones, including, but not limited to:

a. The date the MMTC will obtain login credentials for user acceptance testing;

b. The date the MMTC will begin integrating its Internal STS Tracking System with the Department STS Tracking System; and

c. The date the MMTC will complete integration of its Internal STS Tracking System with the Department STS Tracking System;

4. A contingency plan for tracking marijuana during any period in which the MMTC's Internal STS Tracking System is disconnected from the Department STS Tracking System (meaning communication between the two systems is disrupted) and for transmitting all tracked marijuana data to the Department STS Tracking System once the communication between the two systems is restored; and

5. Names, phone numbers, and email addresses of the MMTC employees responsible for participating in the initial integration process and for maintaining full integration after it is initially established. Only those employees identified by the MMTC as responsible for establishing and maintaining integration are authorized to access the API.

(c) If an MMTC changes its Internal STS Tracking System vendor after achieving full integration, the MTMC must submit a new written integration plan to the department pursuant to the variance process provided in Rule 64-4.023, F.A.C., prior to instituting the change. An MMTC may update its integration plan as needed (e.g., add or remove designated employees responsible for maintaining full integration) pursuant to the variance process provided in Rule 64-4.023, F.A.C.

(5) As a part of its integration with the Department STS Tracking System, an MMTC shall assign a unique product ID to each type of usable product and marijuana delivery device within its current inventory of usable products.

(a) Together with its written integration plan, an MMTC shall identify the unique product IDs the MMTC has assigned to its current inventory of usable products and marijuana delivery devices by completing Form DH5058-OMMU-11/2023, "MMTC Usable Product and Delivery Device Inventory and Unique Product ID," incorporated by referenced herein and available at https://knowthefactsmmj.com/rules-and-regulations/, and submitting the completed form to the department via email at ommu_seedtosale@flhealth.gov.

(b) On or before the date of its third training session with the Department's STS Tracking System vendor, an MMTC shall ensure that its current inventory of marijuana and marijuana delivery devices is entered into its Internal STS Tracking System and that the MMTC's Internal STS Tracking System provides the Department all required information regarding the MMTC's current inventory of marijuana and marijuana delivery devices, as provided in the department's MMTC Seed-to-Sale Tracking System Procedures rule and incorporated material.

(6) An MMTC's failure to comply with the requirements stated herein will result in disciplinary action in accordance with Rule 64-4.210, F.A.C., including suspension and revocation of the MMTC's license.

(7) An MMTC licensed as of the effective date of this rule may request and obtain an extension of the integration deadlines provided in this rule.

(a) The department may grant a request for extension, not to exceed 6 months, where the MMTC demonstrates that compliance with the integration deadlines is not feasible due to hardware failures, software failures, or other technical matters outside of the MMTC's control.

(b) To request an extension of the integration deadlines, an MMTC must submit, prior to expiration of the integration deadlines, a written request to the department via email to ommu_seedtosale@flhealth.gov. The written request must include, without limitation, the following information:

1. The basis for the request, including the detailed facts and reason(s) supporting why compliance with the integration deadlines is not feasible;

2. Documentation demonstrating that the inability to comply with the deadlines is outside of the MMTC's control and not merely the result of delay or lack of resources by the MMTC.

3. The length of the requested extension; and

4. The proposed detailed schedule for achieving full integration within the MMTC's requested timeframe.

Fla. Admin. Code Ann. R. 64ER24-1

Rulemaking Authority Art. X, § 29, Fla. Const., 381.986(8)(k), F.S. Law Implemented Art. X, § 29, Fla. Const., 381.986(8)(d), 381.986(8)(e), F.S.

Adopted by Florida Register Volume 50, Number 011, January 17, 2024 effective 1/12/2024 (EMERGENCY).