1. (a) The following are required for the storage and handling of prescription drugs and for the establishment and maintenance of prescription drug distribution records by wholesale drug distributors and their:

   1. (1) Officers;
   2. (2) Agents;
   3. (3) Representatives; and
   4. (4) Employees.

2. (b) Facilities. All facilities at which prescription drugs are stored, warehoused, handled, held, offered, marketed, or displayed shall:

   1. (1) Be of suitable size and construction to facilitate:

      1. (A) Cleaning;
      2. (B) Maintenance; and
      3. (C) Proper operation;

   2. (2) Have storage areas designed to provide adequate:

      1. (A) Lighting;
      2. (B) Ventilation;
      3. (C) Temperature;
      4. (D) Sanitation;
      5. (E) Humidity;
      6. (F) Space;
      7. (G) Equipment; and
      8. (H) Security conditions;

   3. (3) Have a designated and clearly identified area for storage of prescription drugs that are:

      1. (A) Outdated, damaged, deteriorated, misbranded, or adulterated; or
      2. (B) In immediate or sealed secondary containers that have been opened;
   4. (4) Be maintained in a clean and orderly condition; and
   5. (5) Be free from infestation by insects, rodents, birds, or vermin of any kind.

3. (c) Security.

   1. (1)

      1. (A) All facilities used for wholesale drug distribution shall be secure from unauthorized entry.
      2. (B) Access from outside the premises shall be kept to a minimum and well-controlled.
      3. (C) The outside perimeter of the premises shall be well-lighted.
      4. (D) Entry into areas where prescription drugs are held shall be limited to authorized personnel.

   2. (2)

      1. (A) All facilities shall be equipped with an alarm system to detect entry after hours.
      2. (B) This requirement shall not apply to those wholesale drug distributors of legend/controlled substances that carry only medical gas.

   3. (3)

      1. (A) All facilities shall be equipped with a security system that will provide suitable protection against theft and diversion.
      2. (B) When appropriate, the security system shall provide protection against theft or diversion that is facilitated or hidden by tampering with computers or electronic records.

4. (d) Storage.

   1. (1) All prescription drugs shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such drugs with requirements in the current edition of an official compendium.
   2. (2) If no storage requirements are established for a prescription drug, the drug may be held at “controlled” temperature, as defined in an official compendium, to help ensure that its identity, strength, quality, and purity are not adversely affected.
   3. (3) Appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, devices, and/or logs shall be utilized to document proper storage of prescription drugs.
   4. (4) The recordkeeping requirements in subsection (g) of this section shall be followed for all stored drugs.
   5. (5) The requirements of this subsection do not apply to reverse distributors.

5. (e) Examination of materials.

   1. (1)

      1. (A) Upon receipt, each outside shipping container shall be visually examined for identity and to prevent the acceptance of contaminated prescription drugs or prescription drugs that are otherwise unfit for distribution.
      2. (B) This examination shall be adequate to reveal container damage that would suggest possible contamination or other damage to the contents.

   2. (2) Each outgoing shipment shall be carefully inspected:

      1. (A) For identity of the prescription drug products; and
      2. (B) To ensure that there is no delivery of prescription drugs that have been damaged in storage or held under improper conditions.
   3. (3) The recordkeeping requirements in subsection (g) of this section shall be followed for all incoming and outgoing prescription drugs.

6. (f) Returned, damaged, and outdated prescription drugs.

   1. (1) Prescription drugs that are outdated, damaged, deteriorated, misbranded, or adulterated shall be quarantined and physically separated from other prescription drugs until they are destroyed or returned to their supplier.

   2. (2) Any prescription drugs whose immediate or sealed outer or sealed secondary containers have been opened or used shall be:

      1. (A) Identified as such; and
      2. (B) Quarantined and physically separated from other prescription drugs until they are either destroyed or returned to the supplier.

   3. (3)

      1. (A) If the conditions under which a prescription drug has been returned cast doubt on the drug’s safety, identity, strength, quality, or purity, then the drug shall be destroyed or returned to the supplier unless examination, testing, or other investigation proves that the drug meets appropriate standards of:

7. (i) Safety;

   1. (ii) Identity;

      1. (iii) Strength;

         1. (iv) Quality; and
         2. (v) Purity.

      2. (B) In determining whether the conditions under which a drug has been returned cast doubt on the drug’s safety, identity, strength, quality, or purity, the wholesale drug distributor shall consider, among other things, the:

         1. (i) Conditions under which the drug has been held, stored, or shipped before or during its return; and
         2. (ii) Condition of the drug and its container, carton, or labeling as a result of storage or shipping.
   2. (4) The recordkeeping requirements in subsection (g) of this section shall be followed for all outdated, damaged, deteriorated, misbranded, or adulterated prescription drugs.

8. (g) Recordkeeping.

   1. (1)

      1. (A) Wholesale drug distributors shall establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of prescription drugs.

      2. (B) These records shall include the following information:

         1. (i) The source of the drugs, including the:
9. (a) (a) Name and principal address of the seller or transferor; and

10. (b) (b) Address of the location from which the drugs were shipped;

    1. (ii) The identity and quantity of the drugs received and distributed or disposed of; and

       1. (iii) The dates of receipt and distribution or other disposition of the drugs.
    2. (2) Inventories and records shall be made available for inspection and photocopying by any official authorized by the Arkansas State Board of Pharmacy for a period of two (2) years following disposition of the drugs.

    3. (3)

       1. (A) Records described in this part that are kept at the inspection site or that can be immediately retrieved by computer or other electronic means shall be readily available for authorized inspection during the retention period.
       2. (B) Records kept at a central location apart from the inspection site and not electronically retrievable shall be made available for inspection within two (2) working days of a request by any official authorized by the board.

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