Ariz. Admin. Code § 4-23-615

Current through Register Vol. 30, No. 50, December 13, 2024

Section R4-23-615 - Mechanical Storage and Counting Device for a Drug in Solid, Oral Dosage Form

A. A pharmacy permittee or pharmacist-in-charge shall ensure that a mechanical storage and 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 complies with the following method to identify the contents of the device:

1. The drug name and strength are affixed to the front of each cell or cassette of the device;

2. A paper or electronic log is kept for each cell or cassette that contains:

a. An identification of the cell or cassette by the drug name and strength or the number of the cell or cassette;

b. The drug's manufacturer or National Drug Code (NDC) number;

c. The expiration date and lot number from the manufacturer's stock bottle that is used to fill the cell or cassette. If multiple lot numbers of the same drug are added to a cell or cassette, each lot number and expiration date shall be documented, and the earliest expiration date shall become the expiration date of the mixed lot of drug in the cell or cassette;

d. The date the cell or cassette is filled;

e. Documentation of the identity of the licensee who placed the drug into the cell or cassette; and

f. If the licensee who filled the cell or cassette is not a pharmacist, documentation of the identity of the pharmacist who supervised the non-pharmacist licensee who filled the cell or cassette; and

3. The paper or electronic log is available in the pharmacy for inspection by the Board or its designee for not less than two years.

B. A pharmacy permittee or pharmacist-in-charge shall ensure that any drug previously counted by a mechanical storage and counting device for a drug in a solid, oral dosage form that has not left the pharmacy is not returned to the drug's cell, cassette, or stock bottle, unless the drug return method is approved by the Board or its designee as specified in subsection (G). This subsection does not prevent a pharmacy permittee or pharmacist-in-charge from using a manual or mechanical counting device to count and dispense a previously counted drug that has not left the pharmacy if the previously counted drug is dispensed before its beyond-use-date.

C. A pharmacy permittee or pharmacist-in-charge shall ensure the accuracy of any mechanical storage and 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 storage and counting device for each employee who uses the mechanical storage and counting device;

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

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

D. A pharmacy permittee or pharmacist-in-charge shall ensure that the documentation required in subsection (C) is available for inspection by the Board or its designee.

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

1. Ensure that policies and procedures for the performance and use of a mechanical storage and 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 (E)(1);

3. Document the review required under subsection (E)(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.

F. The Board may prohibit a pharmacy permittee or pharmacist-in-charge from using a mechanical storage and 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), (C), (D), or (E).

G. Returning a drug previously counted by a mechanical storage and counting device for a drug in a solid, oral dosage form that has not left the pharmacy to the drug's cell or cassette.

1. Before returning a drug previously counted by a mechanical storage and counting device that has not left the pharmacy to the drug's cell or cassette, a pharmacy permittee or pharmacist-in-charge shall:

a. Apply for approval from the Board or its designee for the drug return method to be used in returning the drug;

b. Develop a drug return method that uses technology, such as bar coding, to prevent drug return errors;

c. Provide documentation depicting the drug return method;

d. Demonstrate the drug return method for a Board Compliance Officer; and

e. Receive approval from the Board or its designee for the drug return method to be used in returning the drug.

2. Before approving a request to waive the drug return prohibition in subsection (B), the Board or its designee shall:

a. Receive a request in writing from the pharmacy permittee or pharmacist-in-charge;

b. Review the documentation of the drug return method; and

c. Receive a satisfactory inspection report from a Board Compliance Officer that the drug return method uses technology to prevent drug return errors.

Ariz. Admin. Code § R4-23-615

New Section made by final rulemaking at 13 A.A.R. 616, effective April 7, 2007 (Supp. 07-1). Amended by final rulemaking at 14 A.A.R. 3677, effective November 8, 2008 (Supp. 08-3).