# COMAR Title 10 — Maryland Department of Health

## Subtitle 34 — Board of Pharmacy

### Chapter 28 — Automated Medication Systems

#### Regulation .11 Record Keeping.

*COMAR 10.34.28.11*

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.