As used in this
rule, the following terms shall mean:
"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
(3) "Board" shall
mean the Georgia State Board of Pharmacy.
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
(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
(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
(4) The system has adequate
security systems and procedures to prevent unauthorized access to the
(5) The system complies
with federal laws and state regulations;
(6) The system maintains patient
(7) The system
provides a visual image or a description of the medication at final
(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.
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
Ga. Comp. R. & Regs.
Original Rule entitled
"Use of Automated and or Robotic Pharmacy Systems" adopted. F.
Feb. 18, 2013; eff.
Mar. 10, 2013.