1. (a) Purpose.

   1. (1) This part is to implement a state pilot program whereby Arkansas nursing facilities donate unused prescription medications to charitable clinic pharmacies to be dispensed to medically indigent Arkansas residents as authorized under Arkansas Code § 17-92-1101 et seq.
   2. (2) No controlled substance shall be donated or transferred by a nursing facility to or accepted by a charitable clinic pharmacy under this section or 17 CAR § 160-1304.

2. (b) Definitions.

   1. (1) The words defined in Arkansas Code § 17-92-1102 shall have the same meanings in this part unless the context otherwise requires.

   2. (2) As used in this section:

      1. (A) “Charitable clinic pharmacy” means a pharmacy holding a permit issued under 17 CAR § 160-1304; and
      2. (B) “Manifest” means a list of drugs being transferred or destroyed.

3. (c) Donation of prescription drugs.

   1. (1) A charitable clinic pharmacy shall accept donations of unused prescription medications only from Arkansas nursing facilities licensed with the Department of Human Services’ Office of Long-Term Care.

   2. (2) A charitable clinic pharmacy shall accept from such a nursing facility only those unused prescription medications identified in a contract with the nursing facility that has been approved by the Arkansas State Board of Pharmacy in cooperation with the:

      1. (A) Department of Human Services’ Office of Long-Term Care; and
      2. (B) Department of Health.
   3. (3) The charitable clinic pharmacy shall accept only those prescription drugs that the nursing facility has maintained in compliance with the applicable Department of Health rules.

4. (d) The consultant pharmacist for the nursing facility shall be responsible for verifying or causing the following to be performed regarding delivery of unused prescription medication to a charitable clinic pharmacy:

   1. (1) Determine quality and suitability of the unused prescription drugs for reuse by verifying the following:

      1. (A) Healthcare professionals have maintained the drugs in compliance with applicable Department of Health rules;
      2. (B) The drugs can be identified;
      3. (C) The drugs are not adulterated or mutilated; and
      4. (D) The expiration dates are more than thirty (30) days after the date the drugs are to be delivered to the charitable clinic pharmacy;

   2. (2) A manifest has been properly completed to include the following:

      1. (A) Names of the:

5. (i) Consultant pharmacist and director of nursing or designee;

   1. (ii) Nursing home; and

      1. (iii) Receiving pharmacy; and
      2. (B) Name, strength, expiration date, and quantity of each prescription drug to be donated;
   2. (3) A copy of the manifest is delivered to the charitable clinic pharmacist and pharmacy;
   3. (4) Deliver the unused drugs only to a pharmacist designated by the charitable clinic pharmacy;
   4. (5) The name of the patient and any identifying information has been redacted or otherwise removed from the drug packaging before the drugs are delivered to the charitable clinic pharmacy;
   5. (6) Sign and date each manifest before delivery of the unused prescription medications to the charitable clinic pharmacy certifying that he or she has complied with the provisions of this subsection; and

   6. (7)

      1. (A) Maintain a copy of the manifest signed and dated by the charitable clinic pharmacist in the nursing facility for a minimum of two (2) years.
      2. (B) Said document shall be made available upon request by board inspectors.

6. (e) Eligible prescription drugs.

   1. (1)

      1. (A) A charitable clinic pharmacy shall accept from a nursing facility only those unused prescription medications identified in the contract identified in subdivision (c)(2) of this section.
      2. (B) The charitable clinic pharmacy shall not accept any unused prescription medication identified in said contract for which the charitable clinic pharmacy does not have or reasonably anticipate a patient need.

   2. (2) Eligible prescription drugs are:

      1. (A) Those packaged in single-unit doses or blister packs provided that the outside packaging can be opened if the single-unit dose packaging remains intact; or
      2. (B) The manufacturer’s original sealed or tamper-evident packaging.
   3. (3) The expiration date placed on the medication by the original pharmacy dispensing to the nursing home patient, consistent with USP standards, shall become the actual expiration date for the eligible medication.
   4. (4) No lost-identity or unknown drugs shall be accepted by a charitable clinic pharmacy.
   5. (5) No adulterated or misbranded drugs shall be accepted by a charitable clinic pharmacy.
   6. (6) Only those drugs that have physically been in the nursing facility at all times since being dispensed by the originating pharmacy shall be accepted by a charitable clinic pharmacy.
   7. (7) Compounded drugs shall not be accepted by a charitable clinic pharmacy.
7. (f) Patients eligible for donated prescription drugs. The charitable clinic pharmacy shall dispense donated prescription medications only to indigent patients as defined in Arkansas Code § 17-92-1102(4).

8. (g) Pharmacies eligible to accept and dispense unused prescription medications from nursing homes.

   1. (1) A pharmacy shall hold a permit in good standing under 17 CAR § 160-1304.
   2. (2) Prescription medications donated under this section shall not be sold, resold, offered for sale, traded, or transferred to another charitable clinic pharmacy.

9. (h) Procedures for charitable clinic pharmacies to dispense donated prescription drugs.

   1. (1)

      1. (A) A pharmacist on staff at the charitable clinic pharmacy shall verify, utilizing an appropriate reference resource, that the drug name and strength noted on the label of each unit of the packaged donated medication is correct.
      2. (B) The pharmacist verifying the drug shall place his or her initials on the medication label.

      3. (C) If the identity of the drug cannot be verified, the pharmacist:

         1. (i) Shall segregate the unidentified drug for destruction; and
         2. (ii) Shall not dispense the medication.

      4. (D)

         1. (i) Medications shall not be removed from the donor’s original packaging until after verification by the charitable clinic pharmacist.
         2. (ii) A pharmacist shall then relabel the medication with the name and strength of the medication and the expiration date from the donor’s original drug package.
   2. (2) Pharmacists shall dispense unused prescription drugs only upon the valid prescription of an Arkansas-licensed healthcare practitioner.

   3. (3)

      1. (A) Pharmacists shall label each medication to be dispensed according to Arkansas Code § 17-92-505.
      2. (B) Pharmacists shall redact or otherwise remove any labeling on an unused prescription drug identifying the original patient or pharmacy, not removed at the nursing home, prior to delivering the medication to a patient.

      3. (C) Pharmacists shall:

         1. (i) Label all donated drugs dispensed with the name of the charitable clinic pharmacy; and
         2. (ii) Deliver the current drug information to the patient or caregiver.

      4. (D)

         1. (i) Pharmacists shall label all donated drugs dispensed with an expiration date.
         2. (ii) If multiple packages of unused prescription drugs with varied expiration dates are used to fill a single prescription, the earliest expiration date shall be used for the dispensed prescription.
      5. (E) Pharmacists dispensing donated medications shall comply with all aspects of 17 CAR § 160-2901 regarding patient counseling.

   4. (4) Storage.

      1. (A)

         1. (i) The room in which the medications are stored shall be locked at all times except during clinic hours or other times when a licensed pharmacist is physically present in the pharmacy.
         2. (ii) A pharmacist shall be on duty during all hours of pharmacy operation.

      2. (B) The room in which the medications are stored shall have proper environmental controls to ensure the integrity of the medication in accordance with the drug manufacturer’s recommendations.

         1. (i) Responsibilities of pharmacist-in-charge of charitable clinic pharmacy.
   5. (1) Accept delivery of the donated unused prescription drugs from the nursing home in person or cause another pharmacist at the charitable clinic to do so.
   6. (2) Verify that the unused prescription drugs offered by the nursing facility are those identified in the contract described in subdivision (c)(2) of this section and are accurately identified in the manifest provided by the nursing home and resolve any discrepancy before accepting and signing for the medication.
   7. (3) Retain a copy of the nursing facility’s manifest in the pharmacy records for a minimum of two (2) years and make said documents available to board inspectors.

   8. (4)

      1. (A) Cause the unused prescription drugs to be taken directly from the nursing home to the clinic pharmacy to be properly stored.
      2. (B) At no time are the medications to be out of the direct control of a licensed pharmacist.

   9. (5)

      1. (A) Cause expired, adulterated, and lost-identity drugs to be segregated from other medications in the pharmacy and then to be destroyed.
      2. (B) Pharmacists shall not dispense such drugs.
   10. (6) Upon receipt of notice of the recall of a drug, cause a uniform destruction on all of said drugs in the inventory of the charitable clinic, irrespective of lot numbers.

   11. (7) Destruction of drugs.

       1. (A) Create a manifest to be made of expired, adulterated, recalled, and/or other unused prescription drugs, and then cause said drugs to be destroyed.
       2. (B) Observe the destruction of said drugs in the company of a witness, thereafter both of whom sign the manifest verifying the destruction of said drugs.
       3. (C) Maintain a copy of each drug destruction manifest in the files of the pharmacy for a minimum of two (2) years and make said records available for review by board inspectors.

Codification Notes: This section as promulgated prior to codification into the Code of Arkansas Rules provided as follows: “(6/23/05)" "USP" means United States Pharmacopeia.