The following are required for the storage and handling of List I chemicals by wholesale drug distributors and their officers, agents, representatives, and employees:

1. (1) Facilities. All facilities at which List I chemicals are stored, warehoused, handled, held, offered, marketed, or displayed shall:

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

      1. (i) Cleaning;
      2. (ii) Maintenance; and
      3. (iii) Proper operation;

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

      1. (i) Lighting;
      2. (ii) Ventilation;
      3. (iii) Temperature;
      4. (iv) Sanitation;
      5. (v) Humidity;
      6. (vi) Space;
      7. (vii) Equipment; and
      8. (viii) Security conditions;

   3. (C) Have a designated and clearly identified area for storage of List I chemicals that are:

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 (i) Outdated, damaged, deteriorated, misbranded, or adulterated; or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

2. (2) Security.

   1. (A)

      1. (i) All facilities used for wholesale drug distribution shall be secure from unauthorized entry.
      2. (ii) Access from outside the premises shall be kept to a minimum and well-controlled.
      3. (iii) The outside perimeter of the premises shall be well-lighted.
      4. (iv) Entry into areas where List I chemicals are held shall be limited to authorized personnel.
   2. (B) All facilities shall be equipped with an alarm system to detect entry after hours.

   3. (C)

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

3. (3) Storage.

   1. (A) All List I chemicals shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such List I chemicals in the current edition of an official compendium.
   2. (B) If no storage requirements are established for the List I chemical, the chemical 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. (C) Appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, devices, and/or logs shall be utilized to document proper storage of List I chemicals;

4. (4) Examination of materials.

   1. (A)

      1. (i) Upon receipt, each outside shipping container shall be visually examined for identity and to prevent the acceptance of contaminated List I chemicals that are otherwise unfit for distribution.
      2. (ii) This examination shall be adequate to reveal container damage that would suggest possible contamination or other damage to the contents.
   2. (B) Each outgoing shipment shall be carefully inspected for identity of the List I chemical products and to ensure that there is no delivery of List I chemicals that have been damaged in storage or held under improper conditions; and

5. (5) Returned, damaged, and outdated List I chemicals.

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

   2. (B) Any List I chemicals whose immediate or sealed outer or sealed secondary containers have been opened or used shall be:

      1. (i) Identified as such; and
      2. (ii) Quarantined and physically separated from other List I chemicals until they are either destroyed or returned to the supplier.

   3. (C)

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

         1. (a) (a) Safety;
         2. (b) (b) Identity;
      2. (c) (c) Strength;

      3. (d) (d) Quality; and

         1. (e) (e) Purity.

      4. (ii) In determining whether the conditions under which a List I chemical has been returned cast doubt on the product’s safety, identity, strength, quality, or purity, the wholesale distributor of List I chemicals shall consider, among other things, the:

         1. (a) (a) Conditions under which the List I chemical has been held, stored, or shipped before or during its return; and
         2. (b) (b) Condition of the product and its container, carton, or labeling as a result of storage or shipping.