Section R4-23-614. Automated Storage and Distribution System

A.      Before using an automated storage and distribution system, a pharmacy permittee or pharmacist-in-charge shall:

1.        Ensure that the automated storage and distribution system and the policies and procedures comply with subsection (B); and

2.        Notify the Board in writing of the intent to use an auto- mated storage and distribution system, including the type or name of the system.

B.       A pharmacy permittee or pharmacist-in-charge shall establish policies and procedures for appropriate performance and use of the automated storage and distribution system that:

1.        Ensure that the automated storage and distribution system is in good working order while maintaining appropriate recordkeeping and security safeguards;

2.        Ensure that an automated storage and distribution system used by the pharmacy that allows access to drugs or devices by a patient:

a.         Only contains prescriptions that:

i.         Do not require oral consultation as specified in R4-23-402(B); and

ii.        Are properly labeled and verified by a pharma- cist before placement into the automated stor- age and distribution system and subsequent release to patients;

b.        Allows a patient to choose whether or not to use the system;

c.         Is located either in a wall of a properly permitted pharmacy or within 20 feet of a properly permitted pharmacy if the automated storage and distribution system is secured against the wall or floor in such a manner that prevents the automated storage and dis- tribution system’s unauthorized removal;

d.        Provides a method to identify the patient and only release that patient’s prescriptions;

e.         Is secure from access and removal of drugs or devices by unauthorized individuals;

f.         Provides a method for a patient to obtain a consulta- tion with a pharmacist if requested by the patient; and

g.        Does not allow the system to dispense refilled pre- scriptions if a pharmacist determines that the patient requires oral counseling as specified in R4-23- 402(B);

3.        Ensure that an automated storage and distribution system used by the pharmacy that allows access to drugs or devices only by authorized licensed personnel for the pur- poses of administration based on a valid  prescription order or medication order:

a.         Provides for adequate security to prevent unautho- rized individuals from accessing or obtaining drugs or devices; and

b.        Provides for the filling, stocking, or restocking of all drugs or devices in the system only by a Board licensee or other authorized licensed personnel; and

4.        Implement an ongoing quality assurance program that monitors compliance with the established policies and procedures of the automated storage and distribution sys- tem and federal and state law.

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

1.        Ensure that the policies and procedures required under subsection (B) are prepared, implemented, and complied with;

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

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

4.        Assemble the policies and procedures as a written or elec- tronic manual; and

5.        Make the policies and procedures available for employee reference and inspection by the Board or its staff within the pharmacy and at any location outside the pharmacy where the automated storage and distribution system is used.

D.      The Board may prohibit a pharmacy permittee or pharmacist- in-charge from using an automated storage and distribution system 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).