Kan. Admin. Regs. § 68-14-7 - Wholesale distributors; minimum requirements for the storage and handling of prescription-only drugs and devices and for the establishment and maintenance of prescription-only drug and device distribution records
Each wholesale distributor registrant shall meet the following minimum requirements for the storage and handling of prescription-only drugs and devices and for the establishment and maintenance of prescription-only drug and device distribution records by the registrant and its officers, agents, representatives, and employees:
(a)
Facilities. Each facility at which prescription-only drugs and devices are
stored, warehoused, handled, held, offered, marketed, transported from, or
displayed shall meet the following requirements:
(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prescription-only drugs and devices that are outdated, damaged, deteriorated,
misbranded, adulterated, counterfeit, or suspected of being counterfeit, or
that are in immediate or sealed, secondary containers that have been opened or
deemed unfit for distribution;
(4)
be maintained in a clean and orderly condition;
(5) be free from infestation by insects,
rodents, birds, or vermin of any kind;
(6) be a commercial location and not a
personal dwelling or residence;
(7)
have sufficient storage space to maintain records of all transactions for at
least five years; and
(8) be in a
location separate from any other wholesale distributor or pharmacy registered
by the board or another state.
(b) Security.
(1) Each facility used for wholesale
distribution shall 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-only drugs or devices are held shall be limited
to authorized personnel.
(2) Each facility shall be equipped with an
alarm system to detect entry after hours.
(3) Each facility 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.
(4) Each registrant shall ensure adequate
accountability and control of all controlled substances in compliance with the
Kansas uniform controlled substances act, federal drug laws, and all applicable
regulations.
(5) Each registrant
shall verify that all persons or entities who undertake, either directly or by
any other arrangement, to transport prescription-only drugs or devices on
behalf of the registrant ensure security.
(c) Storage. All prescription-only drugs and
devices shall be stored at appropriate temperatures and under appropriate
conditions in accordance with manufacturer's recommendations to preserve the
stability of these drugs and devices.
(1) If
no storage requirements are established for a prescription-only drug or device,
the drug or device may be held at 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, logs, or a combination of these means
shall be utilized to document proper storage of prescription-only drugs and
devices at least once during each 24hour period.
(3) The recordkeeping requirements in
subsection (f) shall be followed for all stored prescription-only drugs and
devices.
(d) Examination
of materials.
(1) Upon receipt, each outside
shipping container shall be visually examined to identify and to prevent the
acceptance of prescription-only drugs or devices that are contaminated or
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-only drugs
or devices and to ensure that there is no delivery of prescription-only drugs
or devices that have been damaged in storage or held under improper
conditions.
(3)
(A) No registrant shall engage in the
wholesale distribution of prescription-only drugs or devices that are purchased
or received from pharmacies or practitioners or from wholesale distributors
that obtained the drugs or devices from pharmacies or practitioners.
(B) Any registrant may receive for
redistribution prescription-only drugs or devices returned from pharmacies or
practitioners that were distributed by the registrant. Before redistribution,
the registrant shall examine the prescription-only drug or device to ensure
that it has not been opened or used. If the prescription-only drug or device
has been opened, it shall be quarantined and physically separated from other
prescription-only drugs or devices until the prescription-only drug or device
is destroyed.
(C) Any registrant
that also operates as a reverse logistics provider or returns processor may
receive prescription-only drugs or devices for destruction from pharmacies and
practitioners regardless of where the drugs or devices are obtained. Each
registrant shall maintain documentation for the disposition of
prescription-only drugs or devices sent for destruction with proof of
destruction, including a certificate of destruction, for inventory
accountability and shall maintain records documenting any return to the
supplier.
(4) The
recordkeeping requirements in subsection (f) shall be followed for all incoming
and outgoing prescription-only drugs or devices.
(e) Returned, damaged, and outdated
prescription-only drugs or devices.
(1)
Prescription-only drugs or devices that are outdated, damaged, deteriorated,
misbranded, or adulterated shall be quarantined and physically separated from
other prescription-only drugs and devices until they are destroyed or returned
to their supplier.
(2) Each
prescription-only drug or device whose immediate or sealed outer or sealed
secondary container has been opened or used shall be identified as such and
shall be quarantined and physically separated from other prescription-only
drugs or devices until the drug or device is either destroyed or returned to
the supplier.
(3) If the conditions
under which a prescription-only drug or device has been returned cast doubt on
the drug's or device's safety, identity, strength, quality, or purity, then the
drug or device shall be destroyed or returned to the supplier, unless
examination, testing, or other investigations prove that the drug or device
meets appropriate standards of safety, identity, strength, quality, and purity.
In determining whether or not the conditions under which a drug or device has
been returned cast doubt on the drug's or device's safety, identity, strength,
quality, or purity, the registrant shall consider, among other factors, the
conditions under which the drug or device has been held, stored, or shipped
before or during its return and the condition of the drug or device and its
container, carton, or labeling, as a result of storage or shipping.
(4) The recordkeeping requirements in
subsection (f) shall be followed for all outdated, damaged, deteriorated,
misbranded, or adulterated prescription-only drugs or devices.
(f) Recordkeeping.
(1) Each registrant shall establish and
maintain inventories and records of all transactions regarding the receipt and
distribution or other disposition of prescription-only drugs and devices. These
records shall include the following information:
(A) The source of the drugs and devices,
including the name and principal address of the seller or transferor, and the
address of the location from which the drugs or devices were shipped;
(B) the identity and quantity of the drugs
and devices received and either distributed or disposed of; and
(C) the dates of receipt and either
distribution or other disposition of the drugs and devices.
(2) Each record related to the
wholesale distribution of prescription-only drugs or devices, including
invoices of purchase or sale, packing slips, and shipment records, shall
accurately reflect the name of the registrant as that name appears on the
registration issued by the board.
(3) Inventories and records shall be made
available for inspection and photocopying by an authorized representative of
the board for five years following disposition of the prescription-only drugs
or devices.
(4) Records described
in this regulation 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 two working days of a
request by an authorized representative of the board.
(5) Each registrant shall post all current
federal and state registrations in a conspicuous place.
(g) Written policies and procedures. Each
registrant shall establish, maintain, and adhere to written policies and
procedures concerning the receipt, security, storage, inventory, and
distribution of prescription-only drugs and devices, including policies and
procedures for identifying, recording, and reporting losses or thefts, and for
correcting all errors and inaccuracies in inventories. In addition, each
registrant shall establish, maintain, and adhere to the following written
policies and procedures:
(1) A procedure by
which the oldest approved stock of a prescription-only drug or device is
distributed first. The procedure may permit deviation from this requirement, if
the deviation is temporary and appropriate to meet the needs of the receiving
facility;
(2) a procedure to be
followed for handling recalls and withdrawals of prescription-only drugs and
devices. This procedure shall be adequate to deal with recalls and withdrawals
due to any of the following:
(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, including the
board;
(B) any voluntary action by
the manufacturer to remove defective or potentially defective drugs or devices
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 distributors prepare for, protect against, and handle any crisis that
affects security or operation of any facility in the event of strike, fire,
flood, or other natural disaster, or other situations of local, state, or
national emergency;
(4) a procedure
to ensure that all outdated prescription-only drugs or devices are segregated
from other drugs or devices and either returned to the manufacturer or
destroyed. This procedure shall provide for written documentation of the
disposition of outdated prescription-only drugs and devices. This documentation
shall be maintained for five years after disposition of the outdated
prescription-only drugs or devices; and
(5) a procedure to ensure that
prescription-only drugs and devices are distributed only to registered entities
with the authority to possess prescription-only drugs or devices in Kansas and
to maintain documentation of this authority as part of the distribution
record.
(h) Responsible
persons. Each registrant shall establish and maintain a list of officers,
directors, managers, and other persons in charge of wholesale prescription-only
drug and device distribution, storage, and handling, including a description of
their duties and a summary of their qualifications. This list shall be made
available for inspection by the board.
(i) Compliance with federal, state, and local
law.
(1) Each registrant that deals in
controlled substances shall register with the DEA.
(2) Each registrant shall permit the board's
authorized personnel to enter and inspect the registrant's premises and
delivery vehicles and to audit the records and written operating procedures, at
reasonable times and in a reasonable manner, to the extent authorized by
law.
(j)
Salvaging and reprocessing. Each registrant shall be subject to the provisions
of any applicable federal, state, or local laws or regulations that relate to
prescription-only drug or device salvaging or reprocessing.
Notes
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