Compilation of Rules and Regulations of the State of Georgia
Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY
Chapter 480-10 - RETAIL PHARMACY REGULATIONS
Rule 480-10-.19 - Use of Automated and or Robotic Pharmacy Systems
Current through Rules and Regulations filed through March 20, 2024
(a) As used in this rule, the following terms shall mean:
(b) A Georgia licensed retail pharmacy may use automated pharmacy systems or robotic pharmacy systems in the preparation of medication for dispensing provided such systems meet the following requirements:
(c) Each retail pharmacy utilizing an APS or RPS must maintain documentation, as to type of equipment, serial numbers, content, policies and procedures, on-site in the pharmacy for review by an agent of the Board.
(d) The filling/stocking of all medications in the APS or RPS shall be performed by licensed pharmacist, licensed pharmacy intern or a registered pharmacy technician under the direct, on-site supervision of a licensed pharmacist. An electronic or hard copy record of medications produced by the system shall be maintained for 2 years, and shall include identification of the person stocking/filling the system, and if a pharmacy intern or registered pharmacy technician, the name of the pharmacist providing the supervision.
(e) Access to and limits on access to the APS or RPS must comply with state and federal laws and regulations. Proper identification and access control, including electronic passwords, biometric identification, unique credentials or other coded identification, must be authorized by the pharmacist on duty. A record of who was assigned the identifications, credentials or passwords must be maintained for 2 years in order to ascertain who accessed the APS or RPS.
(f) The pharmacist in charge ("PIC") of the retail pharmacy is responsible for maintaining all records pertaining to the access, usage, audits and maintenance of the systems. These records must be readily accessible and available for inspection upon request by an agent of the Board. In addition, the PIC is responsible for developing and maintaining policies and procedures to assign, discontinue, or change access to the system, insure that access to the medications comply with state and federal regulations, and insure that the system is filled/stocked.
(g) The pharmacist in charge is responsible to assure that the APS or RPS is in good working order.
(h) Any pharmacist utilizing the APS or RPS must assure that the system is accurately producing the correct strength, dosage form, and quantity of the drug prescribed while maintaining appropriate record keeping and security safeguards.
(i) Any retail pharmacy utilizing an APS or RPS in violation of this rule is subject to disciplinary action which may include, but is not limited to, a restriction on the authority to utilize an APS or RPS.
(j) Nothing herein shall relieve a pharmacist of the professional responsibility to verify the accuracy of the medication being dispensed prior to its being delivered to the patient or the patient's agent
O.C.G.A§§ 26-4-27, 26-4-28, 26-4-60, 26-4-80, 26-4-82, 26-4-83, 26-4-84, 26-4-88, 26-4-110, 26-4-111, 26-4-113 and 43-1-19.