[§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prescription drugs that are outdated, damaged, deteriorated, misbranded, or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".