Ga. Comp. R. & Regs. 351-4-.09

Current through Rules and Regulations filed through November 21, 2024
Rule 351-4-.09 - Transportation
(1) A production licensee shall ensure security and oversight throughout any transport of product, including, but not limited to, compliance with the following:
(a) Transport of product to or from a licensee, pharmacy, or independent laboratory shall be:
1. Transported only by an authorized employee of a licensee or by an employee of an independent laboratory;
2. Entered into the Commission-approved tracking system and properly reflected in inventory totals; and
3. Contained in a sealed package that prevents cross-contamination and labeled as such.
(b) Personal vehicles shall not be utilized to transport products.
(c) A licensee is prohibited from transporting products outside the state of Georgia.
(d) Vehicles and trailers transporting products are subject to inspection by the Commission or its employees at any time.
(e) A licensee shall notify the Commission and its employees immediately when:
1. A vehicle transporting products is involved in any accident or other situation involving product loss;
2. There is a stop at a location that exceeds one (1) hour in duration and is not already listed in the shipping manifest; or
3. A mechanical issue involving the transport vehicle necessitates the transfer of product to an alternate vehicle to complete the transport. The licensee shall enter the information into the Commission-approved tracking system immediately to reflect the change.
(2) A production licensee shall establish, maintain, and follow standard operating procedures for the transport of product. Such procedures, and changes to such procedures, shall be maintained on the premises and made available to employees of such licensee.
(3) A production licensee shall maintain a current list, updated monthly, of such licensee's drivers, including the following information of each employee:
(a) First, middle, and last name;
(b) Date of birth;
(c) Photograph; and
(d) Contact information including telephone number.
(4) A production licensee shall register each vehicle or vehicle-trailer combination used for the transportation of product by submitting the following to the Commission:
(a) A copy of the vehicle registration or lease which shall include the Vehicle Identification Number ("VIN") assigned by the vehicle manufacturer;
(b) A copy of the vehicle's annual safety inspection;
(c) A copy of the vehicle's unique vehicle number assigned by the production licensee; and
(d) Photos of the vehicle:
1. Left front corner;
2. Right front corner;
3. Right rear corner;
4. Rear, including the affixed, government-issued license plate;
5. Left rear corner; and
6. VIN plate.
(5) All vehicles utilized for transporting product shall contain a global positioning system ("GPS") device for identifying the geographic location of the transport vehicle.
(a) The device shall be permanently affixed to the transport vehicle.
(b) The device shall remain active at all times during transportation of products.
(c) At all times, the production licensee shall be able to identify the geographic location of all vehicles and employees transporting product.
(d) The production licensee shall provide the GPS information to the Commission or its employees upon request.
(e) The use of cellular telephones as a device for GPS tracking does not meet the requirements of this rule.
(6) All vehicles shall be equipped with the following:
(a) Climate control capabilities to ensure the integrity of the product transported;
(b) A vehicle alarm system designed to discourage theft and unauthorized entry or access to the vehicle; and
(c) Permanently installed video cameras that shall:
1. Record during the transport of product;
2. Provide constant coverage of the driver and product being transported; and
3. Maintain recorded material available for no less than forty-five (45) days and be made available for review by the Commission or its employees upon request.
(7) A production licensee shall ensure that the following transportation security requirements are followed:
(a) All transport vehicles shall be staffed with a minimum of two (2) employees who are at least twenty-one (21) years of age. At least one (1) transport team member shall remain with the vehicle at all times that the vehicle contains products;
(b) Employees shall carry their employee identification and valid state-issued driver license at all times when transporting or delivering products;
(c) Employees shall produce their identification to the Commission or its employees or to a law enforcement officer acting in the course of official duties upon request;
(d) Products shall only be transported inside of a registered vehicle or trailer and shall not be visible or identifiable from outside of the vehicle or trailer;
(e) Products shall be locked in a fully enclosed box, container, or cage that is secured to the inside of the vehicle or trailer, shielded from view from the exterior of the vehicle. No portion of the enclosed box, container, or cage shall be comprised of any part of the body of the vehicle or trailer. For the purposes of this section, the inside of the vehicle also includes, but is not limited to, the trunk and cargo areas;
(f) The vehicle transporting the products shall not contain any marks, logos, brands, or other illustrations on the exterior of the vehicle, other than those affixed to the vehicle by the vehicle manufacturer or dealership, or required placards and signage; and
(g) All transport times and routes are randomized and within the borders of the state of Georgia.
(8) A production licensee shall ensure all shipments comply with the following requirements:
(a) Prior to transporting product off of the premises, the licensee originating the shipment shall prepare a shipping manifest that contains the following information:
1. The name, license number, and premises address of the originating licensee;
2. The name, license number, and premises address of the licensee or pharmacy receiving the product into inventory or storage;
3. The batch number(s) for all product being transported;
4. The item name, description, count, and weight of product associated with each batch;
5. The estimated date and time of departure from the premises;
6. The estimated date and time of arrival at each premises;
7. The valid driver's license number of each employee transporting product, and the make, model, and license plate number of the vehicle used for transport; and
8. Name and signature of the employees accompanying the transport.
(b) During transportation, the licensee transporting the product shall maintain a physical or digital copy of the shipping manifest.
(c) When a shipment is complete, the licensee shall:
1. Enter a record verifying the receiving licensee's, pharmacy's, or independent laboratory's receipt of the shipment in the Commission-approved tracking system with the details of the shipment;
2. Ensure that the shipment has been received by the receiving licensee, pharmacy, or independent laboratory is as described on the shipping manifest; and
3. Immediately adjust its inventory records to reflect such receipt.
(d) A licensee shall not alter the information of the receiving licensee, pharmacy, or independent laboratory after the information has been entered on the shipping manifest. However, if any product on the shipping manifest is damaged or otherwise undeliverable, then the licensee shall:
1. Off-load damaged product only when it can be properly quarantined in the receiving licensee's, pharmacy's, or independent laboratory's inventory and storage;
2. Document the receipt of any damaged product and the quantities received in the Commission-approved tracking system;
3. Update the shipping manifest accordingly; and
4. Maintain a log of any damaged and any returned product as set forth in Rule 351-4-.11.

Ga. Comp. R. & Regs. R. 351-4-.09

O.C.G.A. §§ 16-12-203, 16-12-206, 16-12-210, 16-12-211, 16-12-212, 16-12-213, 16-12-217.

Original Rule entitled "Transportation" adopted. F. Mar. 16, 2023; eff. Apr. 5, 2023.
Amended: F. Nov. 9, 2023; eff. Nov. 29, 2023.