Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 4
Subtitle 34 - BOARD OF PHARMACY
Chapter 10.34.28 - Automated Medication Systems
Section 10.34.28.11 - Record Keeping
Universal Citation: MD Code Reg 10.34.28.11
Current through Register Vol. 51, No. 19, September 20, 2024
A. The permit holder and the responsible pharmacist shall maintain records regarding the automated medication system in a readily retrievable manner for at least 5 years.
B. The records referred to in §A of this regulation shall include:
(1) Maintenance records and service
logs;
(2) System failure
reports;
(3) Documentation of
patient outcomes resulting from system failures;
(4) Accuracy audits and system performance
audits;
(5) Copies of reports and
analyses generated as part of the quality assurance program, including daily
accuracy sampling;
(6) Reports or
databases related to level of access and changes in the level of access to the
system;
(7) Training records
including:
(a) Contents of the training
program;
(b) Dates of training
completion; and
(c) The identity of
those attending the training program;
(8) Records of destruction of medication
waste removed from the system, to include an independent witness signature;
and
(9) Transaction information as
follows:
(a) Transactions involving
medications stored in or removed, dispensed, or distributed from the
system;
(b) Medications dispensed
or distributed for a patient, which shall be recorded to include the:
(i) Identity of the particular automated
medication system accessed;
(ii)
Identification of the individual accessing the system;
(iii) Date of transaction;
(iv) Name, strength, dosage form, and
quantity of drug accessed; and
(v)
Name of the patient for whom the drug was accessed; and
(c) Records of stocking or removal of
medications from an automated medication system, which shall include the:
(i) Date;
(ii) Name, strength, dosage form, and
quantity of drug stocked or removed; and
(iii) Name, initials, or identification code
of the individual stocking or removing drugs from the system.
Disclaimer: These regulations may not be the most recent version. Maryland may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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