Ga. Comp. R. & Regs. 351-6-.05

Current through Rules and Regulations filed through November 21, 2024
Rule 351-6-.05 - Dispensing License Operations
(1) All rooms on the premises shall be identified on the respective doors or the exterior of such rooms so as to indicate the purposes of such rooms.
(2) Common areas in the dispensary, including but not limited to, a designated area for the consumption of food and beverages for employees, toilet and lavatory facilities, office or meeting space, or a lobby, shall conform to the following requirements:
(a) The common areas shall be separated from restricted access areas by floor-to-ceiling-high walls;
(b) The door separating the common areas from the restricted access areas shall have secure electronic controls to restrict access; and
(c) Toilet and lavatory facilities shall be equipped with toilet tissue, soap dispenser with soap or other hand cleaning material, sanitary towels or drying device, and at least one (1) waste receptacle.
(3) All areas where product in final packaged form is stored shall be:
(a) Dry;
(b) Sufficiently lit;
(c) Well-ventilated;
(d) Maintained in a clean and orderly fashion; and
(e) Maintained at temperatures and lighting conditions which will ensure the integrity of product in final packaged form prior to dispensing.
(4) Upon receipt of transported product in final packaged form from a licensee, the receiving dispensing licensee shall do all of the following:
(a) Submit to the Commission-approved tracking system a record verifying its receipt of the shipment and the details of the shipment.
(b) Ensure that the product in final packaged form received is as described in the shipping manifest and shall immediately adjust its records to reflect the receipt of inventory. If such product is damaged, then such licensee:
1. May accept the damaged product only if such product can be properly recorded in its inventory and quarantined at the dispensary.
2. Separately document the receipt of any damaged product in final packaged form on the shipping manifest and the quantities received in the Commission-approved tracking system.
(5) A dispensing licensee shall establish, maintain, and follow standard operating procedures for the accurate and safe dispensing of product in final packaged form to patients and caregivers. Such procedures, and changes to such procedures, shall be maintained on the premises and made available to employees of such licensee.
(6) Prior to dispensing product in final packaged form to a patient or caregiver, a dispensing licensee shall ensure a patient or caregiver has an active and valid registration card as referenced in Code Section 16-12-191 and proof of identification.
(7) If a dispensing licensee receives information about a patient's adverse event, then such licensee shall notify the originating production licensee, as well as the Commission and its employees, within twenty-four (24) hours of such licensee's receipt of information.
(8) For product in final packaged form that cannot be dispensed, a dispensing licensee shall establish, maintain, and follow standard operating procedures which shall address, at a minimum, the following:
(a) Identification and storage of any product in final packaged form that are:
1. Expired or no longer have a current and passing certificate of analysis;
2. Not properly labeled or packaged; or
3. Quarantined due to damage, evidence of tampering, a part of a recall, or as otherwise required to be quarantined pursuant to the rules of the Commission or procedures established by the licensee.
(b) Security and storage protocols to ensure that, prior to returning such product to the originating production licensee, product in final packaged form will be stored in:
1. A securely enclosed and locked container; and
2. A restricted access area of the dispensary.
(9) A dispensing licensee shall not do any of the following:
(a) Accept, store, or dispense any product not in final packaged form;
(b) Use the Commission's name or logo on any sign at the premises, on the business' website, or in any advertising or social media, except to the extent that the Commission's name or logo is contained on the proof of licensure or is incorporated into warnings, signage, or other documents required by these rules;
(c) Sublet any portion of the dispensary;
(d) Provide samples of or free products to any person;
(e) Allow products to be administered, applied, ingested, or otherwise consumed inside of or on the premises of the dispensary;
(f) Offer any tours of restricted access areas to the general public; or
(g) Display product in final packaged form in windows or in public view.

Ga. Comp. R. & Regs. R. 351-6-.05

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

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