Ill. Admin. Code tit. 68, § 1510.120 - Minimum Requirements for the Storage and Handling of Prescription Drugs and for the Establishment and Maintenance of Prescription Drug Distribution Records
The following are minimum requirements for the storage and handling of prescription drugs, and for the establishment and maintenance of prescription drug distribution records by wholesale drug distributors and third-party logistics providers, and their officers, agents, representatives and employees:
a) Facilities. All
facilities at which prescription drugs are stored, warehoused, handled, held,
offered, marketed or displayed shall:
1) Be
of suitable size and construction to facilitate cleaning, maintenance and
proper operations;
2) Have storage
areas designed to provide adequate lighting, ventilation, temperature,
sanitation, humidity, space, equipment and security conditions;
3) Have a quarantine area for storage of
prescription drugs that are outdated, damaged, deteriorated, misbranded or
adulterated, or that are in immediate or sealed secondary containers that have
been opened;
4) Be maintained in a
clean and orderly condition; and
5)
Be free from infestation by insects, rodents, birds or vermin of any
kind.
b) Security. All
facilities used for wholesale drug distribution shall:
1) Be secure from unauthorized entry.
A) Access from outside the premises shall be
kept to a minimum and be well controlled.
B) The outside perimeter of the premises
shall be well-lighted.
C) Entry
into areas where prescription drugs are held shall be limited to authorized
personnel;
2) Be
equipped with an alarm system to detect entry after hours; and
3) 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.
c) Storage. All
prescription drugs shall be stored at appropriate temperatures and under
appropriate conditions, in accordance with requirements, if any, in the
labeling of those drugs, or with requirements in the current edition of an
official compendium such as the United States Pharmacopoeia and National
Formulary.
1) 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.
2) Appropriate manual, electromechanical, or
electronic temperature and humidity recording equipment, devices and/or logs
shall be utilized to document proper storage of prescription drugs.
3) The recordkeeping requirements in
subsection (f) shall be followed for all stored drugs.
d) Examination of Materials
1) Upon receipt, each outside shipping
container shall be visually examined to identify the product 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.
2) Each outgoing
shipment shall be carefully inspected to identify the prescription drug
products and to ensure that there is no delivery of prescription drugs that
have been damaged in storage or held under improper conditions.
3) The recordkeeping requirements in
subsection (f) shall be followed for all incoming and outgoing prescription
drugs.
e) Returned,
Damaged and Outdated Prescription Drugs
1)
Prescription drugs that are outdated, damaged, deteriorated, misbranded or
adulterated shall be quarantined and physically separated from other
prescription drugs until they are destroyed or returned to their
supplier.
2) Any prescription drugs
whose immediate or sealed outer or sealed secondary containers have been opened
or used shall be identified accordingly and shall be quarantined and separated
from other prescription drugs until they are either destroyed or returned to
the supplier.
3) If the conditions
under which a prescription drug has been returned cast doubt on the drug's
safety, identity, strength, quality or purity, the drug shall be 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 or, identity, strength,
quality or purity, the wholesale drug distributor and/or third-party logistics
provider shall consider, among other things:
A) the conditions under which the drug has
been held, stored or shipped before or during its return; and
B) the condition of the drug and its
container, carton or labeling because of the storage or shipping.
4) The recordkeeping requirements
in subsection (f) shall be followed for all outdated, damaged, deteriorated,
misbranded or adulterated prescription drugs.
f) Recordkeeping
1) Wholesale drug distributors and
third-party logistics providers shall establish and maintain inventories and
records of all transactions regarding the receipt and distribution or other
disposition of prescription drugs. These records shall include the following
information:
A) The source of the drugs,
including the name and principal address of the seller or transferor and the
address of the location from which the drugs were shipped;
B) The identity and quantity of the drugs
received and distributed or disposed of; and
C) The dates of receipt and distribution or
other disposition of the drugs.
2) Inventories and records shall be made
available, for a period of 2 years following disposition of the drugs, for
inspection and photocopying by drug compliance investigators or any authorized
official of any drug enforcement governmental agency charged with enforcement
of this Part.
3) Records described
in this Section that are kept at the inspection site or that can be immediately
retrieved by computer or other electronic means shall be readily available for
authorized inspection during the retention period. Records kept at a central
location apart from the inspection site and not electronically retrievable
shall be made available for inspection within 2 working days after a request by
an authorized official of any federal, state and local agencies charged with
enforcement of this Part.
g) Written Policies and Procedures. Wholesale
drug distributors and third-party logistics providers shall establish, maintain
and adhere to written policies and procedures that shall be followed for the
receipt, security, storage, inventory and distribution of prescription drugs,
including policies and procedures for identifying, recording and reporting
losses or thefts, and for correcting all errors and inaccuracies in
inventories. Wholesale drug distributors shall include in their written
policies and procedures the following:
1) A
procedure in which the oldest approved stock of a prescription drug product is
distributed first. The procedure may permit deviation from this requirement if
the deviation is temporary and appropriate.
2) A procedure to be followed for handling
recalls and withdrawals of prescription drugs. This procedure shall be adequate
to deal with recalls and withdrawals due to:
A) Any action initiated at the request of the
Food and Drug Administration or other federal, state or local law enforcement
or other government agency;
B) Any
voluntary action by the manufacturer to remove defective or potentially
defective drugs from the market; or
C) Any action undertaken to promote public
health and safety by replacing existing merchandise with an improved product or
new package design.
3) A
procedure to ensure that wholesale drug distributors prepare for, protect
against, and handle any crisis that affects security or operation of any
facility in the event of strike or fire, flood or other natural disaster, or
other situations of local, state or national emergency.
4) A procedure to ensure that any outdated
prescription drugs shall be segregated from other drugs and either returned to
the manufacturer or destroyed. This procedure shall provide for written
documentation of the disposition of outdated prescription drugs. This
documentation shall be maintained for 2 years after disposition of the outdated
drugs.
h) Responsible
Persons. Wholesale drug distributors and third-party logistics providers shall
establish and maintain lists of officers, directors, managers and other persons
in charge of wholesale drug distribution, storage and handling, including a
description of their duties and a summary of their qualifications.
i) Compliance with Federal, State and Local
Laws. Wholesale drug distributors and third-party logistics providers shall
operate in compliance with applicable federal, state and local laws and
regulations.
1) Wholesale drug distributors
and third-party logistics providers shall permit drug compliance investigators
of the Department and authorized federal, state and local law enforcement
officials, at reasonable times, in a reasonable manner, and upon presentation
of appropriate identification, to the extent authorized by law, to:
A) enter and inspect their premises and
delivery vehicles; and
B) audit
their records and written operating procedures.
2) Wholesale drug distributors and
third-party logistics providers who deal in controlled substances shall
register with the appropriate state-controlled substance authority and with the
Drug Enforcement Administration (DEA), and shall comply with all applicable
state, local and DEA regulations.
j) Salvaging and Reprocessing. Wholesale drug
distributors and third-party logistics providers shall be subject to the
provisions of any applicable federal, state or local laws or regulations that
relate to prescription drug product salvaging or
reprocessing.
Notes
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