Ga. Comp. R. & Regs. 351-5-.02

Current through Rules and Regulations filed through November 21, 2024
Rule 351-5-.02 - Approved Tracking System Requirements
(1) Any seed-to-sale tracking vendor shall not have a direct or indirect financial interest in any licensee or registrant of the Commission.
(2) A Commission-approved tracking system vendor shall:
(a) Provide the Commission and its employees access to real-time tracking data;
(b) Utilize an Application Programming Interface designed to integrate with the Commission's state tracking system to include:
1. Inventory management and tracking systems to shipping manifests;
2. Test results; and
3. Dispensing point-of-sale data.
(c) Establish, document, and maintain procedures to prevent fraud, abuse, and other unlawful or prohibited activities associated with the production and dispensing of regulated cannabis in this state, and the ability to provide additional tools for the administration and enforcement of the Act and these rules; and
(d) Institute procedures to ensure that the information in the system shall not be disclosed or used for any purpose other than to ensure public health and safety, product quality and efficacy, and compliance with the Act and these rules.
(3) The tracking system shall be capable of:
(a) Tracking all plants, products, packages, amounts dispensed to patients, waste disposals, transfers, conversions, and returns that, if practicable, are linked to unique identification numbers;
(b) Tracking batch information throughout the entire chain of custody;
(c) Tracking all regulated cannabis throughout the entire chain of custody;
(d) Tracking regulated cannabis destruction;
(e) Performing complete batch recall tracking that clearly identifies all of the following details relating to the specific batch subject to the recall:
1. Amount of product in final packaged form dispensed;
2. Amount of product in final packaged form that has been used for the potential therapeutic treatment of program participants;
3. Amount of product in final packaged form inventory that is finished and available for dispensing;
4. Amount of regulated cannabis being processed into another form; and
5. Amount of post-harvest regulated cannabis, such as regulated cannabis that is in the drying, trimming, or curing process.
(f) Reporting and tracking loss, theft, or diversion of regulated cannabis;
(g) Reporting and tracking all inventory discrepancies;
(h) Reporting and tracking adverse patient responses or dose related efficacy issues;
(i) Reporting and tracking all transfers and returns;
(j) Receiving electronically submitted information required to be reported under the Act;
(k) Receiving testing results electronically within twenty-four (24) hours of completion from an independent laboratory via a secured API into the tracking system and directly linking the testing results to each applicable source batch and sample;
(l) Flagging test results that have characteristics indicating that they may have been altered;
(m) Providing information to ensure that the product in final packaged form has been dispensed to a patient or caregiver, and that the product in final packaged form received and passed the required testing;
(n) Providing the Commission and its employees with real-time access to information in the tracking system; and
(o) Providing real-time information to the Commission and its employees regarding key performance indicators, including:
1. Total regulated cannabis in production;
2. Total daily transfers of product in final packaged form;
3. Total product in final packaged form dispensed;
4. Total regulated cannabis destroyed; and
5. Total inventory adjustments.

Ga. Comp. R. & Regs. R. 351-5-.02

O.C.G.A. §§ 16-12-203, 16-12-206, 16-12-210, 16-12-213.

Original Rule entitled "Approved Tracking System Requirements" adopted. F. Mar. 16, 2023; eff. Apr. 5, 2023.