1. (a) The definitions in Arkansas Code § 17-92-1102 are applicable in this part unless the context otherwise requires.

2. (b) Permit.

   1. (1)

      1. (A)

3. (i) Application for a pilot program permit for the reuse of donated prescription medications authorized by Arkansas Code § 17-92-1101 et seq., shall be on a form provided by the Arkansas State Board of Pharmacy, signed by the pharmacist-in-charge, and submitted pursuant to board rule, but the fee for the application will be waived.

   1. (ii) The application and documentation identified in the following subparagraph shall be delivered to the board's office thirty (30) days prior to the meeting at which the applicant desires to appear for consideration of its application.

      1. (B) The application shall be accompanied by appropriate documentation including:

         1. (i) That necessary to qualify the applicant as a charitable clinic as defined in Arkansas Code § 17-92-1102(1);
         2. (ii) Written policies and procedures for the operation of the charitable clinic pharmacy;
         3. (iii) Protocols to include the procedure for screening and determining that the patient qualifies on the basis of income below two hundred percent (200%) of the federal poverty level;
         4. (iv) A depiction of the physical facilities for the pharmacy and a description of provisions for security for and access to the pharmacy;
         5. (v) A statement of any fees charged to patients;
         6. (vi) A list stating the pharmacy’s:
4. (a) (a) Hours of operation;

5. (b) (b) Equipment; and

   1. (c) (c) Library materials; and

      1. (vii) The proposed contract with a nursing home or nursing homes for donation of unused prescription medications.
      2. (C) The pharmacist-in-charge and an appropriate officer or director of the organization shall appear before the board for its consideration of the application.
      3. (D) The contract with the nursing home for supplying donated prescription drugs must be renewed biennially.
      4. (E) Either volunteer or paid healthcare professionals shall deliver pharmaceutical services for the pharmacy.

   2. (2) Prior to opening the charitable clinic pharmacy, the pharmacist-in-charge shall notify the board in writing identifying each pharmacist who will work at the pharmacy and, within ten (10) days thereafter, provide similar notice of any changes in pharmacists working in the pharmacy.

      1. (c) Pharmacy operations.

   3. (1)

      1. (A) A pharmacy holding a permit under this part shall stock and dispense purchased legend drugs, donated prescription drugs, samples, and medications received from manufacturer-sponsored prescription drug assistance programs or any other sources.
      2. (B) Provided, however, that the pharmacy shall not stock or dispense any controlled substance.
   4. (2) Pharmacists shall dispense all medications to patients on individual prescriptions, shall properly label all drugs dispensed, and shall comply with requirements for storing, safeguarding, preparing and keeping records for prescription drugs as described in 17 CAR § 160-1706.

   5. (3) The pharmacist-in-charge shall cause the approved written policies, procedures, contracts with nursing homes, and protocols for the operation of the pharmacy to be maintained and available in the pharmacy for use by pharmacy staff and review by board inspectors.

      1. (d) Physical facilities. The pharmacy shall:
   6. (1) Be locked when a pharmacist is not present in the pharmacy; and
   7. (2) Have adequate facilities for performing pharmaceutical services including the procurement, storage, distribution, security, and control of said drugs consistent with all federal and state laws and rules.
6. (e) Changes in pharmacy operations. The pharmacist-in-charge shall obtain approval by the Executive Director of the Arkansas State Board of Pharmacy prior to any change in any item identified in subdivisions (b)(1)(B)(i) – (vii) of this section.
7. (f) Limited-use technician permit. The board may issue a restricted charitable clinic pharmacy technician permit for the sole purpose of performing pharmacy technician duties as a volunteer in a prescription drug redispensing program permitted in accordance with subsection (b) of this section.

Codification Notes: This section as promulgated prior to codification into the Code of Arkansas Rules provided as follows: “(6/23/05, Revised 6/30/07)"