1. A. General provisions.

   1. 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. 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. 3. To obtain an automated prescription-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. 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. 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.

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

   1. 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:

      1. a. Maintaining a record of each transaction in a manner that attaches the record to the permit number of the automated prescription-dispensing kiosk;
      2. b. Controlling access to the automated prescription-dispensing kiosk;
      3. c. Operating the automated prescription-dispensing kiosk;
      4. d. Training personnel who use the automated prescription-dispensing kiosk;
      5. e. Maintaining patient services when the automated prescription-dispensing kiosk is not operating or the prescribed drug or device is not available;
      6. 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;
      7. g. Assuring a patient receives the pharmacy services necessary for appropriate pharmaceutical care including consultation with a pharmacist;
      8. h. Maintaining integrity of information in the system and patient confidentiality;
      9. i. Stocking and restocking the automated prescription-dispensing kiosk;
      10. j. Ensuring compliance with packaging and labeling requirements; and
      11. k. Removing drugs and devices from the automated prescription-dispensing kiosk without dispensing them and handling wasted or discarded drugs and devices;
   2. 2. Ensure the policies and procedures are implemented and complied with by all personnel using the automated prescription-dispensing kiosk;

   3. 3. Maintain the policies and procedures by:

      1. a. Reviewing the policies and procedures biennially and making needed revisions, if any;
      2. b. Documenting the review required under subsection (B)(3)(a);
      3. c. Assembling the policies and procedures as a written or electronic manual; and
      4. 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. 4. Implement a quality assurance program to monitor compliance with the policies and procedures and all state and federal law.
3. C. Change of ownership. An automated prescription-dispensing kiosk permittee shall comply with R4-23-601(F).
4. D. An automated prescription-dispensing kiosk permittee shall renew the permit as specified under R4-23-602(D).
5. E. The Board shall adhere to the time frames specified under R4-23-602(C) when processing an initial or renewal application for an automated prescription-dispensing kiosk permit.

Historical Note

New Section made by final rulemaking at 25 A.A.R. 1012, effective June 1, 2019 (Supp. 19-2).