Ariz. Admin. Code § R4-23-616 - Mechanical Counting Device for a Drug in Solid, Oral Dosage Form

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. Training in the maintenance, calibration, and use of the mechanical counting device for each employee who uses the mechanical counting device;

2. Maintenance and calibration of the mechanical counting device as recommended by the device's manufacturer; and

3. Routine quality assurance and accuracy validation testing for each mechanical counting device.

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.

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

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. Review biennially and, if necessary, revise the policies and procedures required under subsection (C)(1);

3. Document the review required under subsection (C)(2);

4. Assemble the policies and procedures as a written or electronic manual; and

5. Make the policies and procedures available within the pharmacy for employee reference and inspection by the Board or its staff.

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).

Notes

Ariz. Admin. Code § R4-23-616

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