1. A. A pharmacy permittee or pharmacist-in-charge shall ensure the accuracy of any mechanical counting device for a drug in a solid, oral dosage form that is used by a pharmacist or a pharmacy intern, graduate intern, pharmacy technician, or pharmacy technician trainee under the supervision of a pharmacist by documenting completion of the following:

   1. 1. Training in the maintenance, calibration, and use of the mechanical counting device for each employee who uses the mechanical counting device;
   2. 2. Maintenance and calibration of the mechanical counting device as recommended by the device’s manufacturer; and
   3. 3. Routine quality assurance and accuracy validation testing for each mechanical counting device.
2. B. A pharmacy permittee or pharmacist-in-charge shall ensure that the documentation required in subsection (A) is available for inspection by the Board or its designee.

3. C. A pharmacy permittee or pharmacist-in-charge shall:

   1. 1. Ensure that policies and procedures for the performance and use of a mechanical counting device for a drug in a solid, oral dosage form are prepared, implemented, and complied with;
   2. 2. Review biennially and, if necessary, revise the policies and procedures required under subsection (C)(1);
   3. 3. Document the review required under subsection (C)(2);
   4. 4. Assemble the policies and procedures as a written or electronic manual; and
   5. 5. Make the policies and procedures available within the pharmacy for employee reference and inspection by the Board or its staff.
4. D. The Board may prohibit a pharmacy permittee or pharmacist-in-charge from using a mechanical counting device for a drug in a solid, oral dosage form if the pharmacy permittee or the pharmacy permittee’s employees do not comply with the requirements of subsections (A), (B), or (C).

Historical Note

New Section made by final rulemaking at 13 A.A.R. 616, effective April 7, 2007 (Supp. 07-1).