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(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.

(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.

History: 37-7-201, MCA; IMP, 37-7-201, MCA; NEW, 1985 MAR p. 1017, Eff. 7/26/85; AMD, 1998 MAR p. 3103, Eff. 11/20/98; AMD, 2002 MAR p. 178, Eff. 2/1/02; TRANS, from Commerce, 2002 MAR p. 904.

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