Sec. 10.13.02.04. Storage and Handling

A. Storage Facility. A designated Department representative shall store, hold, or handle prescription drugs and devices in a facility that:

(1) Is constructed to facilitate:

(a) Cleaning; and

(b) Maintenance;

(2) Has storage areas designed to provide adequate:

(a) Equipment;

(b) Humidity control;

(c) Lighting;

(d) Sanitation;

(e) Security conditions;

(f) Space;

(g) Temperature; and

(h) Ventilation;

(3) Has a secured separate quarantine area for storage of prescription drugs or devices that are:

(a) Adulterated;

(b) Damaged;

(c) Deteriorated;

(d) In immediate or sealed secondary containers that have been opened;

(e) Misbranded; or

(f) Outdated;

(4) Is maintained in a clean and orderly condition; and

(5) Is free from insects, rodents, birds, or vermin.

B. Storage.

(1) A designated Department representative shall store a prescription drug or device at appropriate temperatures and under appropriate conditions in accordance with requirements:

(a) If any, on the labeling of the prescription drug or device; or

(b) Set forth in the current edition of an official compendium, such as the United States Pharmacopeia/National Formulary (USP/NF).

(2) If no storage requirements are established for a prescription drug or device, a designated Department representative shall hold the prescription drug or device at a controlled room temperature, as defined in an official compendium as set forth in §B(1)(b) of this regulation to help assure that its identity, strength, quality, and purity are not adversely affected.

(3) A designated Department representative shall document proper storage of prescription drugs and devices in accordance with the:

(a) Use of manual, electromechanical, or electronic temperature and humidity recording equipment, devices, and logs; and

(b) Record-keeping requirements in Regulation .06 of this chapter for stored prescription drugs and devices.

C. Examination of Materials.

(1) Upon receipt of a prescription drug or device, a designated Department representative shall visually examine each outside shipping container to prevent the acceptance of:

(a) An adulterated prescription drug or device; or

(b) A prescription drug or device that is otherwise unfit for distribution.

(2) A designated Department representative shall examine each prescription drug or device container, as required under §C(1) of this regulation, to ascertain whether there is any damage to the container that would suggest possible contamination or other damage to the contents.

(3) A designated Department representative shall carefully inspect each outgoing shipment:

(a) For identity of the prescription drug or device being shipped; and

(b) To ensure that there is no delivery of a prescription drug or device that has been damaged in storage or held under improper conditions.

(4) Each unit of the Department, such as a local health department, that receives delivery of the prescription drug or device shall meet the requirements of this regulation for storage, security, and record keeping.

(5) A designated Department representative shall follow the record-keeping requirements in Regulation .06 of this chapter for an incoming and an outgoing prescription drug or device.

D. Security of the Storage Area. A designated Department representative shall ensure that the area where prescription drugs and devices are stored is secure from unauthorized entry as follows:

(1) Access from outside the premises is:

(a) Kept to a minimum; and

(b) Limited to authorized personnel as determined by the designated Department representative; and

(2) The storage area is equipped with:

(a) A security system that provides protection against theft and diversion;

(b) An inventory management and control system that protects against, detects, and documents any instances of theft, diversion, or counterfeiting; and

(c) A security system that protects the integrity and confidentiality of data and documents.

E. Authorized Access of Storage Area. A designated Department representative shall ensure that the area where prescription drugs and devices are stored:

(1) Has a means in place to make the data and documentation required under this chapter readily available to the Board, an agent of the Board, or federal or State law enforcement officials; and

(2) Allows for inspection by a Board representative.