1. (a) A retail pharmacy with a licensed pharmacy permit may also act as a central fill pharmacy if the following requirements are met.

2. (b) Definition. As used in this part:

   1. (1) “Central fill pharmacy” means a pharmacy that is licensed by the Arkansas State Board of Pharmacy (“the board”) to prepare legend and controlled substances orders for dispensing pursuant to a valid prescription transmitted to it by a licensed retail pharmacy and to deliver the labeled and filled prescriptions in accordance with federal and state law.
   2. (2) Provided, however, the central fill pharmacy may deliver prescriptions for controlled substances only in accordance with Drug Enforcement Administration regulations.

   3. (3) Such a central fill pharmacy shall be deemed authorized to fill prescriptions on behalf of a retail pharmacy only if the retail pharmacy and central fill pharmacy:

      1. (A) Have a contractual relationship providing for such activities; or
      2. (B) Share a common owner.
   4. (4) Both the retail pharmacy and the central fill pharmacy involved in these activities share a corresponding responsibility regarding central fill prescriptions.

3. (c) Recordkeeping.

   1. (1)

      1. (A) Every retail pharmacy that utilizes the services of a central fill pharmacy must keep a record of all central fill pharmacies, including name, address, and Drug Enforcement Administration number, that are authorized to fill prescriptions on its behalf.
      2. (B) The retail pharmacy must also verify the registration for each central fill pharmacy authorized to fill prescriptions on its behalf at the beginning of each registration period for the central fill pharmacy.
      3. (C) These records must be made available upon request for inspection.

   2. (2)

      1. (A) Every central fill pharmacy must keep a record of all retail pharmacies, including name, address, and Drug Enforcement Administration number, for which it is authorized to fill prescriptions.
      2. (B) The central fill pharmacy must also verify the registration for all retail pharmacies for which it is authorized to fill prescriptions at the beginning of each registration period for each retail pharmacy.
      3. (C) These records must be made available upon request for inspection.

4. (d) Provision of prescription information of Schedule II controlled substances.

   1. (1)

      1. (A) Prescriptions for controlled substances listed in Schedule II may be transmitted electronically from a retail pharmacy to a central fill pharmacy, including via facsimile.
      2. (B) The retail pharmacy transmitting the prescription information must:
5. (i) Electronically record or write the word “CENTRAL FILL” on the face of the original prescription and record the:
6. (a) (a) Name, address, and Drug Enforcement Administration registration number of the central fill pharmacy to which the prescription has been transmitted;
7. (b) (b) Name of the retail pharmacy pharmacist transmitting the prescription; and

8. (c) (c) Date of transmittal;

   1. (ii) Ensure that all information required to be on a prescription pursuant to federal and state law is transmitted to the central fill pharmacy, either on the face of the prescription or in the electronic transmission of information;

      1. (iii) Maintain the original prescription for a period of two (2) years from the date the prescription was filled; and

         1. (iv) Keep a record of receipt of the filled prescription, including the:
9. (a) (a) Date of receipt;

10. (b) (b) Method of delivery (private, common, or contract carrier);

    1. (c) (c) Identity of carrier; and

       1. (d) (d) Name of the retail pharmacy employee accepting delivery.

    2. (2) The central fill pharmacy receiving the transmitted prescription must:

       1. (A) Keep a copy of the prescription, if sent via facsimile, or an electronic record of all the information transmitted by the retail pharmacy, including the name, address, and Drug Enforcement Administration registration number of the retail pharmacy transmitting the prescription;

       2. (B) Keep a record of the:

          1. (i) Date of receipt of the transmitted prescription;
          2. (ii) Name of the pharmacist filling the prescription; and
          3. (iii) Date of filling of the prescription;

       3. (C) Track the prescription drug order during each step in the filling process and identify the name or names, initials, or identification code or codes, and specific activity or activities of each pharmacist or pharmacy technician who performed any portion of the process including:

          1. (i) Transmission;
          2. (ii) Filling;
          3. (iii) Dispensing; or
          4. (iv) Delivery; and

       4. (D) Keep a record of the:

          1. (i) Date the filled prescription was delivered to the retail pharmacy;
          2. (ii) Method of delivery, i.e., private, common, or contract carrier; and
          3. (iii) Identity of the carrier.
    3. (3) Central fill pharmacies shall not be authorized to prepare prescriptions for a controlled substance listed in Schedule II upon receiving an oral authorization from a retail pharmacist or an individual practitioner.

11. (e) Provision of prescription information for initial and refill prescriptions of legend or Schedules III, IV, or V controlled substances.

    1. (1)

       1. (A) Prescriptions for legend or controlled substances listed in Schedules III, IV, or V may be transmitted electronically from a retail pharmacy to a central fill pharmacy, including via facsimile.

       2. (B) The retail pharmacy transmitting the prescription information must:

          1. (i) Electronically record or write the words “CENTRAL FILL” on the face of the original prescription and record the:
12. (a) (a) Name, address, and Drug Enforcement Administration registration number of the central fill pharmacy to which the prescription has been transmitted;

13. (b) (b) Name of the retail pharmacy pharmacist transmitting the prescription; and

    1. (c) (c) Date of transmittal;

       1. (ii) Ensure that all information required to be on a prescription pursuant to federal and state law is transmitted to the central fill pharmacy, either on the face of the prescription or in the electronic transmission of information;

          1. (iii) Indicate in the information transmitted the number of refills already dispensed and the number of refills remaining;
          2. (iv) Maintain the original prescription for a period of two (2) years from the date the prescription was last refilled; and
          3. (v) Keep a record of receipt of the filled prescription, including the:
14. (a) (a) Date of receipt;

15. (b) (b) Method of delivery (private, common, or contract carrier);

    1. (c) (c) Identity of the carrier; and

       1. (d) (d) Name of the retail pharmacy employee accepting delivery.

    2. (2) The central fill pharmacy receiving the transmitted prescription must:

       1. (A) Keep a copy of the prescription, if sent via facsimile, or an electronic record of all the information transmitted by the retail pharmacy, including the name, address, and Drug Enforcement Administration registration number of the retail pharmacy transmitting the prescription;

       2. (B) Keep a record of the:

          1. (i) Date of receipt of the transmitted prescription;
          2. (ii) Name of the licensed pharmacist filling the prescription; and
          3. (iii) Dates of filling or refilling of the prescription;

       3. (C) Track the prescription drug order during each step in the filling process and identify the name or names, initials, or identification code or codes, and specific activity or activities of each pharmacist or pharmacy technician who performed any portion of the process including:

          1. (i) Transmission;
          2. (ii) Filling;
          3. (iii) Dispensing; or
          4. (iv) Delivery; and

       4. (D)

          1. (i) Keep a record of the:
16. (a) (a) Date the filled prescription was delivered to the retail pharmacy;

17. (b) (b) Method of delivery (i.e., private, common, or contract carrier); and

    1. (c) (c) Identity of the carrier.

       1. (ii) Prescriptions for controlled substances that are prepared by the central fill pharmacy may only be delivered to the ultimate user in accordance with Drug Enforcement Administration regulations.

18. (f) Carriers to transport filled prescriptions.

    1. (1)

       1. (A) Central fill pharmacies must comply with all federal and state requirements when using private, common, or contract carriers to transport filled prescriptions to:

          1. (i) The ultimate user; or
          2. (ii) A retail pharmacy for delivery to the ultimate user.
       2. (B) When central fill pharmacies contract with private, common, or contract carriers to transport filled prescriptions to a retail pharmacy, the central fill pharmacy is responsible for reporting in-transit losses upon discovery of such loss by use of a Drug Enforcement Administration Form 106.

    2. (2)

       1. (A) Retail pharmacies must comply with all federal and state laws when using private, common, or contract carriers to retrieve filled prescriptions from a central fill pharmacy.
       2. (B) When retail pharmacies contract with private, common, or contract carriers to retrieve filled prescriptions from a central fill pharmacy, the retail pharmacy is responsible for reporting in-transit losses upon discovery of such loss by use of a Drug Enforcement Administration Form 106.

19. (g) Labeling. The central fill pharmacy shall:

    1. (1) Affix to the package a label showing the retail pharmacy name and address and a unique identifier, which shall be the central fill pharmacy’s Drug Enforcement Administration registration number or a board-assigned identifier, indicating that the prescription was filled at the central fill pharmacy;
    2. (2) Indicate in some manner which pharmacy filled the prescription, e.g., “Filled by ABC Pharmacy for XYZ Pharmacy”; and
    3. (3) Comply with all other labeling requirements of federal and state statutes.

20. (h) Policies and procedures.

    1. (1) A policy and procedure manual as it relates to centralized filling shall be:

       1. (A) Maintained at the filling, originating, and dispensing pharmacies; and
       2. (B) Available for inspection.
    2. (2) Each pharmacy is required to maintain only those portions of the policy and procedure manual that relate to that pharmacy’s operations.

    3. (3) The manual shall:

       1. (A) Outline the responsibilities of each of the filling, originating, and dispensing pharmacies;
       2. (B) Include a list of the names, addresses, telephone numbers, and all license/registration numbers of the pharmacies involved in centralized prescription filling; and

       3. (C) Include policies and procedures for:

          1. (i) Notifying patients that their prescriptions may be outsourced to another pharmacy for centralized prescription filling, and the name of that pharmacy;
          2. (ii) Protecting the confidentiality and integrity of patient information;
          3. (iii) Dispensing prescription drug orders when the:
21. (a) (a) Filled order is not received; or

22. (b) (b) Patient comes in before the order is received;

    1. (iv) Complying with federal and state laws and rules;

       1. (v) Operating a continuous quality improvement program for pharmacy services designed to objectively and systematically:
23. (a) (a) Monitor and evaluate the quality and appropriateness of patient care;

24. (b) (b) Pursue opportunities to improve patient care; and

    1. (c) (c) Resolve identified problems; and

       1. (vi) Annually reviewing the written policies and procedures and documenting such review.

Codification Notes: This section as promulgated prior to codification into the Code of Arkansas Rules provided as follows: “(11/15/2003, Revised 3/14/2006, Amended 5/31/2014)"