In order to comply with the record keeping requirements of this
Chapter, an automated electronic data processing system may be utilized for the
record keeping system if the following conditions have been met:
(a) Except as otherwise provided herein, all
original prescriptions, those hard copies written by a practitioner, telephoned
to the pharmacist by a practitioner and reduced to writing, or sent via
facsimile machine or other electronic means must be retained as a permanent
record for two years in the usual consecutively serial numbered prescription
file. Any refill information subsequently authorized by a practitioner must be
maintained in the manner required by O.C.G.A. §
The system shall at a minimum produce
sight-readable records for all dangerous drug and controlled substance
prescriptions filled or refilled during each 24 hour period. The term
"sight-readable" means that a representative of the Board or GDNA shall be able
to immediately retrieve and examine the record and read the information during
any on-site visit to the pharmacy. For purposes of off-site audits and review,
a separate copy of any sight-readable hard-copy printout or electronic readable
file (such as a PDF file) of each daily record shall be made available to a
representative of the Board of GDNA upon verbal request by that representative.
These daily prescription records can:
generated as hard-copy print-outs at least once weekly, separated into each 24
hour period, by the pharmacy and maintained for at least two years after the
last date on which the prescription was filled or refilled. If a hard-copy
printout of each day's filled and refilled prescription is generated, that
printout shall be verified, dated, and signed by the individual pharmacist who
refilled such a prescription order. The individual pharmacist must verify that
the data indicated are correct and then sign this document in the same manner
as he would sign a check or legal document (e.g., J.H. Smith, or John H.
Smith). This document shall be maintained in a separate file at that pharmacy
for a period of two years from the dispensing date; or
2. Be maintained electronically. The
computers on which the records are maintained may be located at another
location, but the records must be immediately retrievable as hard-copy
print-outs or viewing on a computer monitor set aside for such viewing at each
individually registered pharmacy upon a verbal request by a representative from
the Board or GDNA. The computer software must be capable of printing out or
transferring the prescription records in a format that is readily
understandable to the representative for the Board or GDNA at the registered
location. Prescription records must also be sortable and retrievable by
prescriber name, patient name, drug dispensed, and date filled. When utilizing
electronic daily prescription fill and refill records, each pharmacy shall
maintain a bound log book, or separate file, in which each individual
pharmacist involved in such dispensing shall sign a statement each day,
attesting to the fact that the prescription information entered by him or her
into the computer that day has been reviewed by him or her and is correct as
shown. Such a book or file must be maintained at the pharmacy employing such
software for a period of two years after the date of dispensing the
appropriately authorized refill.
The information maintained by the
automated electronic data processing system shall include, but not be limited
to the following:
1. Date of
5. Drug name, strength and
prescribed, and if the quantity dispensed is different from the quantity
prescribed, the quantity dispensed;
7. Prescriber's name;
8. Identification of dispensing
9. Indication whether
drugs are being dispensed pursuant to a new prescription or for a refill
10. In case of a controlled
substance as allowed by federal law, the name, address and DEA registration of
the practitioner and the schedule of the drug;
11. Directions for administration of the
prescription to the patient;
Total number of refills authorized; and
13. NPI of the prescriber as assigned under
Permanent records of electronic prescriptions for dangerous drugs and
controlled substances do not have to be reduced to hard copy provided the
following requirements are met:
prescription data must be maintained in the original format received for a
minimum of two years; and
Reliable backup copies of the information are readily retrievable and stored in
a secure and fireproof (minimum 1 hr UL approved) container, stored in a
secured offsite location or backed up to a documented offsite secure storage
device within 48 hours following each work day.
(e) The individual pharmacist responsible for
completeness and accuracy of the entries to the system must provide
documentation that prescription information entered into the computer is
correct, by dating and signing the print-out in the same manner as signing a
check or legal document (e.g., Mary A. Smith or M. A. Smith).
(f) An auxiliary record-keeping system shall
be established for the documentation of filling new prescriptions, refills, and
transfers if the automated electronic data processing system is inoperative for
any reason. The auxiliary system shall insure that all refills are authorized
by the original prescription and that the maximum number of refills is not
exceeded. When this automated electronic data processing system is restored to
operation, the information regarding prescriptions filled and refilled during
the inoperative period shall be entered into the automated electronic data
processing system as soon as possible. However, nothing in this section shall
preclude the pharmacist from using his/her professional judgment for the
benefit of a patient's health and safety.
(g) Any pharmacy using an automated
electronic data processing system must comply with all applicable State and
Federal laws and regulations.
pharmacy shall make arrangements with the supplier of data processing services
or materials to insure that the pharmacy continues to have adequate and
complete prescription and dispensing records if the relationship with such
supplier terminates for any reason. A pharmacy shall insure continuity in the
maintenance of records.
Ga. Comp. R. & Regs.
Original Rule entitled
"Security" adopted. F. Nov. 26, 1986;
eff. Dec. 16, 1986.
New Rule entitled "Record-Keeping When Utilizing an Automated Data
Processing System" adopted. F. July 24,
2002; eff. August 13, 2002.
New Rule of same title adopted. F. Aug. 18,
2006; eff. Sept. 7, 2006.
F. Dec. 14, 2012; eff.
Jan. 3, 2013.
F. Sep. 17, 2014; eff.
Oct. 7, 2014.