Ariz. Admin. Code § R4-23-677 - Automated Prescription- dispensing Kiosk Perm

A. General provisions.

1. Only a person issued a Board permit under A.R.S. § 32-1929 to operate a pharmacy in Arizona may apply to the Board under A.R.S. § 32-1930 for a permit to operate an automated prescription-dispensing kiosk.

2. A pharmacy permittee described under subsection (A)(1) shall apply for a separate permit for each automated prescription-dispensing kiosk to be operated.

3. To obtain an automated prescript ion-dispensing kiosk permit, a pharmacy permittee shall submit a completed application, using a form available on the Board's website, and the fee specified in R4-23-205.

4. A pharmacy permittee to which the Board issues an automated prescription-dispensing kiosk permit shall designate a pharmacist in charge of the automated prescription-dispensing kiosk.

5. A pharmacy permittee to which the Board issues an automated prescription-dispensing kiosk permit shall not place the automated prescription-dispensing kiosk in a gas station or convenience store.

B. Policies and procedures. A pharmacy permittee to which the Boar dissues an automated prescription-dispensing kiosk permit shall:

1. Ensure policies and procedures are established for the appropriate performance and use of the automated prescription-dispensing kiosk. The policies and procedures shall address:

a. Maintaining a record of each transaction in a manner that attaches the record to the permit number of the automated prescription-dispensing kiosk;

b. Controlling access to the automated prescription-dispensing kiosk;

c. Operating the automated prescription-dispensing kiosk;

d. Training personnel who use the automated prescription-dispensing kiosk;

e. Maintaining patient services when the automated prescription-dispensing kiosk is not operating or the prescribed drug or device is not available;

f. Securing the automated prescription-dispensing kiosk against unauthorized removal of the kiosk or access to or removal of drugs or devices from the kiosk;

g. Assuring a patient receives the pharmacy services necessary for appropriate pharmaceutical c are including consultation with a pharmacist;

h. Maintaining integrity of information in the system and patient confidentiality;

i. Stocking and restocking the automated prescription-dispensing kiosk;

j. Ensuring compliance with packaging and labeling requirements; and

k. Removing drugs and devices from th e automated prescription-dispensing kiosk without dispensing them and handling wasted or discarded drugs and devices;

2. Ensure the policies and procedures are implemented and complied with by all personnel using th e automated prescription-dispensing kiosk;

3. Maintain the policies and procedures by:

a. Reviewing the policies and procedures biennially and making needed revisions, if any;

b. Documenting the review required under subsection (B)(3)(a);

c. Assembling the policies and procedures as a written or electronic manual; and

d. Making the policies and procedures available within the pharmacy permittee to which the Board issued an automated prescription-dispensing kiosk permit for reference by pharmacy personnel and inspection by the Board; and

4. Implement a quality assurance program to monitor compliance wit h the policies and procedures and all state and federal law.

C. Change of ownership. An automated prescription-dispensing kiosk permittee shall comply with R4-23-601(F).

D. An automated prescript ion-dispensing kiosk permittee shall renew the permit as specified under R4-23-602(D).

E. The Board shall adhere to the ti me frames specified under R4-23-602(C) when processing an initial or renewal application for a n automated prescription-dispensing kiosk permit.

Notes

Ariz. Admin. Code § R4-23-677

Adopted by final rulemaking at 25 A.A.R. 1012, effective 6/1/2019.