Administrative Rules of Montana
Department 24 - LABOR AND INDUSTRY
Chapter 24.174 - BOARD OF PHARMACY
Subchapter 24.174.8 - Pharmacies
Rule 24.174.817 - AUTOMATED RECORD KEEPING SYSTEMS
Universal Citation: MT Admin Rules 24.174.817
Current through Register Vol. 6, March 22, 2024
(1) An automated system may be employed for the record keeping system, if the following conditions have been met:
(a) The
system shall have the capability of producing legible documents of all original
and refilled prescription information. During the course of an on-site
inspection the records must be accessible for viewing or printing.
(b) The individual pharmacist responsible for
completeness and accuracy of the entries to system must provide documentation
of the fact that prescription information entered into the computer is correct.
In documenting this information, the pharmacy shall have the option to either:
(i) 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 into the computer that day has been reviewed and is correct
as shown. Such a book or file must be maintained at the pharmacy employing such
a system for a period of at least two years after the date of last dispensing;
or
(ii) provide a printout of each
day's prescription information. That printout shall be verified, dated and
signed by the individual pharmacist verifying that the information indicated is
correct and then sign this document in the same manner as signing a check or
legal document (e.g., J. H. Smith, or John H. Smith). Such printout must be
maintained at least two years from the date of last dispensing; or
(iii) utilize a software system which
requires a unique log in for each function such that it can be easily and
accurately determined who performed every function within the prescription
dispensing process. The records must be readily accessible for viewing or
printing at the request of the board.
(c) An auxiliary recordkeeping system shall
be established for the documentation of refills if the automated 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 system is restored to operation,
the information regarding prescriptions filled and refilled during the
inoperative period shall be entered into the automated system within 96 hours.
However, nothing in this section shall preclude the pharmacist from using his
professional judgment for the benefit of a patient's health and
safety.
(d) Any pharmacy using an
automated system must comply with all applicable state and federal laws and
regulations.
37-7-201, MCA; IMP, 37-7-201, MCA;
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