[§328-119]  Minimum requirements for thestorage and handling of prescription drugs.  Wholesale distributors ofprescription drugs and their officers, agents, representatives, and employeesshall ensure that the following requirements are met:

(1)  Facilities.  All facilities at which prescriptiondrugs are stored, warehoused, handled, held, offered for sale or distribution,marketed, or displayed shall:

(A)  Be of suitable size and construction tofacilitate cleaning, maintenance, and proper operations;

(B)  Have storage areas designed to provideadequate lighting, ventilation, temperature, sanitation, humidity, space,equipment, and security conditions;

(C)  Have a quarantine area for storage ofprescription drugs that are outdated, damaged, deteriorated, misbranded, oradulterated, or that are in immediate containers or sealed secondary containersthat have been opened;

(D)  Be maintained in a clean and orderlycondition; and

(E)  Be free from infestation by insects,rodents, birds, and vermin of any kind.

(2)  Security.

(A)  All facilities used for wholesaledistribution, storage, or warehousing of prescription drugs shall be securefrom unauthorized entry.

(i)  Access from outside the premises shall bekept to a minimum and shall be well controlled.

(ii)  The outside perimeter of the premises shallbe well lighted.

(iii)  Entry into areas where prescription drugsare held shall be limited to authorized personnel.

(B)  All facilities shall be equipped with analarm system to detect entry after hours.

(C)  All facilities shall be equipped with asecurity system that will provide suitable protection against theft anddiversion.  When appropriate, the security system shall provide protectionagainst theft or diversion that is facilitated or hidden by tampering withcomputers or electronic records.

(3)  Storage.  All prescription drugs shall be storedat appropriate temperatures and under appropriate conditions in accordance withthe requirements, if any, in the labeling of the drugs, or in accordance withthe standards regarding conditions and temperatures for the storage ofprescription drugs adopted under this part.

(A)  If no storage requirements are establishedfor 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, orelectronic temperature and humidity recording equipment, devices, or logs shallbe used to document the proper storage of prescription drugs.

(4)  Examination of materials.

(A)  Upon receipt, each outside shippingcontainer of prescription drugs shall be examined visually to confirm theidentity of the drugs and to prevent the acceptance of contaminatedprescription drugs or prescription drugs that are otherwise unfit fordistribution.  This examination shall be adequate to reveal container damagethat would suggest possible contamination or other damage to the contents.

(B)  Each outgoing shipment of prescriptiondrugs shall be inspected carefully to confirm the identity of the drugs and toensure that no prescription drugs are delivered that have been damaged instorage or held under improper conditions.

(C)  The recordkeeping requirements in section328-120 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 physicallyseparated from other prescription drugs and stored, in such a way that nocross-contamination or confusion are possible, until they are destroyed orreturned to the supplier.

(B)  Any prescription drugs whose immediate orsealed outer or sealed secondary containers are found upon arrival to have beenopened or used shall be identified as such, and shall be physically separatedfrom other prescription drugs and stored, in such a way that nocross-contamination or confusion are possible, until they are destroyed orreturned to the supplier.

(C)  If the conditions under which aprescription drug has been returned cast doubt on the drug’s safety, identity,strength, quality, or purity, then the drug shall be either destroyed orreturned to the supplier, unless examination, testing, or other investigationproves that the drug meets appropriate standards of safety, identity, strength,quality, and purity.  In determining whether the conditions under which a drughas been returned cast doubt on the drug’s safety, identity, strength, quality,or purity, the wholesale distributor shall consider, among other things, theconditions under which the drug has been held, stored, or shipped before orduring its return and the condition of the drug and its container, carton, orlabeling as a result of storage or shipping.

(D)  The recordkeeping requirements in section328-120 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 insection 2 of this Act".

  "Section 328-120" substituted for "section 8of this Act".