§328-119 Minimum requirements for the storage and handling of prescription drugs. Wholesale distributors of prescription drugs and their officers, agents, representatives, and employees shall ensure that the following requirements are met:
(1) Facilities. All facilities at which prescription drugs are stored, warehoused, handled, held, offered for sale or distribution, marketed, or displayed shall:
(A) Be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;
(B) Have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions;
(C) Have a quarantine area for storage of prescription drugs that are outdated, damaged, deteriorated, misbranded, or adulterated, or that are in immediate containers or sealed secondary containers that have been opened;
(D) Be maintained in a clean and orderly condition; and
(E) Be free from infestation by insects, rodents, birds, and vermin of any kind.
(2) Security.
(A) All facilities used for wholesale distribution, storage, or warehousing of prescription drugs shall be secure from unauthorized entry.
(i) Access from outside the premises shall be kept to a minimum and shall be well controlled.
(ii) The outside perimeter of the premises shall be well lighted.
(iii) Entry into areas where prescription drugs are held shall be limited to authorized personnel.
(B) All facilities shall be equipped with an alarm system to detect entry after hours.
(C) All facilities shall be equipped with a security system that will provide suitable protection against theft and diversion. 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) Storage. All prescription drugs shall be stored at appropriate temperatures and under appropriate conditions in accordance with the requirements, if any, in the labeling of the drugs, or in accordance with the standards regarding conditions and temperatures for the storage of prescription drugs adopted under this part.
(A) If no storage requirements are established for a prescription drug, the drug may be held at controlled room temperature, as defined in an official compendium, to help ensure that its identity, strength, quality, and purity are not adversely affected.
(B) Appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, devices, or logs shall be used to document the proper storage of prescription drugs.
(4) Examination of materials.
(A) Upon receipt, each outside shipping container of prescription drugs shall be examined visually to confirm the identity of the drugs and to prevent the acceptance of contaminated prescription drugs or prescription drugs that are otherwise unfit for distribution. This examination shall be adequate to reveal container damage that would suggest possible contamination or other damage to the contents.
(B) Each outgoing shipment of prescription drugs shall be inspected carefully to confirm the identity of the drugs and to ensure that no prescription drugs are delivered that have been damaged in storage or held under improper conditions.
(C) The recordkeeping requirements in section 328-120 shall be followed for all incoming and outgoing prescription drugs.
(5) Returned, damaged, outdated, deteriorated, misbranded, and adulterated prescription drugs.
(A) Prescription drugs that are damaged, outdated, deteriorated, misbranded, or adulterated shall be physically separated from other prescription drugs and stored, in such a way that no cross-contamination or confusion are possible, until they are destroyed or returned to the supplier.
(B) Any prescription drugs whose immediate or sealed outer or sealed secondary containers are found upon arrival to have been opened or used shall be identified as such, and shall be physically separated from other prescription drugs and stored, in such a way that no cross-contamination or confusion are possible, until they are destroyed or returned to the supplier.
(C) 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 either destroyed or returned to the supplier, unless examination, testing, or other investigation proves that the drug meets appropriate standards of safety, identity, strength, quality, and purity. 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 distributor shall consider, among other things, the conditions under which the drug has been held, stored, or shipped before or during its return and the condition of the drug and its container, carton, or labeling as a result of storage or shipping.
(D) The recordkeeping requirements in section 328-120 shall be followed for all outdated, damaged, deteriorated, misbranded, adulterated or returned prescription drugs. [L 1992, c 196, pt of §2]
Revision Note
"This part" substituted for "the new part in section 2 of this Act".
"Section 328-120" substituted for "section 8 of this Act".