An automated data processing system may be employed as a
record-keeping system in a pharmacy if the following conditions are met:
(1) The system has the capability of
producing sight-readable documents of all original and refilled prescription
information. The term "sight-readable" means that a regulatory agent is able to
examine the record and read the information. In administrative proceedings
before the Board, records must be provided in a readable paper printout
(2) Information includes the
prescription requirements and records of dispensing as indicated in Rules .2301
and .2302 of this Section.
individual pharmacist responsible for completeness and accuracy of the entries
to the system provides documentation of the fact that prescription information
entered into the computer is correct.
(4) Documentation in Item (3) of this Rule is
provided in the pharmacy within 72 hours of date of dispensing.
(5) An auxiliary recordkeeping system is
established for the documentation of refills if the automated data processing
system is inoperative for any reason. When the automated data processing system
is restored to operation, the information regarding prescriptions filled,
refilled or transferred during the inoperative period shall be entered into the
automated data processing system within the time equal to the number of
inoperative days times three; for example, if the system were inoperative for
five days then all interim data shall be entered within 15 days of the last
inoperative day. However, nothing in this Item precludes the pharmacist from
using professional judgment for the benefit of a patient's health and safety.
The auxiliary record keeping system shall be backed up at least
(6) The pharmacy makes
arrangements with the supplier of data processing services or materials to
assure that the pharmacy continues to have adequate and complete prescription
and dispensing records if the relationship with the supplier is terminated for
any reason. A pharmacy shall assure continuity in the maintenance of
(7) A current version of
drug interactions software is used and policies and procedures are established
to address overriding the software's alerts of any drug interactions.