Ga. Comp. R. & Regs. R. 480-10-.19 - Use of Automated and or Robotic Pharmacy Systems

(a) As used in this rule, the following terms shall mean:

(1) "Automated pharmacy systems" (APS) means a mechanical system that perform operations or activities, other than compounding or administration, relative to storage, packaging, and labeling of medication for the purpose of dispensing of medication to a patient or patient's agent.

(2) "Robotic pharmacy systems" (RPS) means a mechanical system controlled by a computer that performs operations or activities relative to the storage, packaging, and labeling of medication for the purpose of distribution (dispensing) of medication to a patient or a patient's agent.

(3) "Board" shall mean the Georgia State Board of Pharmacy.

(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:

(1) The system collects, controls, and maintains all transaction information;

(2) The system is located within the licensed pharmacy, or if in a general merchandising store, within the pharmacy department;

(3) Medication loaded into the system can be visually identified as well as identified by bar code or other such secondary identification system to ensure the proper medication is being placed into and recognized as the correct medication by the system;

(4) The system has adequate security systems and procedures to prevent unauthorized access to the system;

(5) The system complies with federal laws and state regulations;

(6) The system maintains patient confidentiality;

(7) The system provides a visual image or a description of the medication at final verification.

(8) The system can only be accessed by personal code.

(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

Notes

Ga. Comp. R. & Regs. R. 480-10-.19

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.

Original Rule entitled "Use of Automated and or Robotic Pharmacy Systems" adopted. F. Feb. 18, 2013; eff. Mar. 10, 2013.