Third party logistics providers - general operations
The following requirements shall apply
to all persons licensed as third party logistics providers:
where dangerous drugs are stored, warehoused, handled, held, offered, marketed,
or displayed shall:
||Be of suitable size and construction to facilitate
cleaning, maintenance, and proper operations;
areas designed to provide adequate lighting, ventilation, temperature,
sanitation, humidity, space, equipment, and security conditions;
quarantine area for storage of dangerous drugs that are damaged, deteriorated,
misbranded, or adulterated, or that are in immediate or sealed secondary
containers that have been opened. Such drugs shall be stored in accordance with
paragraph (B) of this rule;
||Be maintained in
a clean and orderly condition;
||Be free from
infestation by insects, rodents, birds, or vermin of any kind.
||Adulterated drugs shall be stored in a separate and secure
area apart from the storage of drugs used for distribution and sale.
shall be stored no longer than two years from the date of adulteration or
expiration. Adulterated drugs shall be stored in a manner that prohibits access
by unauthorized persons.
||Dangerous drugs, other than controlled substances, may
be destroyed utilizing proper methods of disposal and following the record
keeping requirements noted in paragraph (B)(2)(a) of this rule, or may be
donated to a pharmacy school pursuant to sections
3715.92 of the Revised Code.
Methods of disposal of non-controlled dangerous drugs shall prevent the
possession or use of the drugs by unauthorized persons.
Records of dangerous drug destructions,
other than controlled substances, shall contain the name, strength, dosage
form, and quantity of the dangerous drug destroyed, the date destroyed, the
method of destruction, the positive identification of the responsible person
that performed the destruction, and the positive identification of the person
that witnessed the destruction.
that are controlled substances shall be disposed of pursuant to rule 4729:6-3-01 of the Administrative Code.
used by third party logistics providers shall be secure from unauthorized
||Access from outside the premises shall be kept to a minimum
and be well controlled.
||The outside perimeter of the premises shall be well
||Entry into areas where dangerous drugs are stored shall
be limited to authorized personnel.
where dangerous drugs are stored shall be equipped with an alarm system to
detect unauthorized entry after hours.
shall be equipped with a security system that will provide suitable protection
against theft and diversion. The security system shall provide protection
against theft or diversion that is facilitated or hidden by tampering with
computers or electronic records.
drugs shall be stored at appropriate temperatures and under appropriate
conditions in accordance with requirements, if any, in the labeling of such
drugs, or with requirements in the current edition of an official compendium,
such as the United States pharmacopoeia/national formulary (USP/NF).
||If no storage
requirements are established for a dangerous drug, the drug may be held at
"controlled" room temperature, as defined in an official compendium, to help
ensure that its strength, quality, and purity are not adversely affected.
||Appropriate manual, electromechanical, or electronic
temperature and humidity recording equipment, devices, and/or logs shall be
utilized to document proper storage of dangerous drugs. Temperature and
humidity documentation shall be made readily retrievable and maintained for a
period of not less than three years from the last documented temperature and
||All shipments of
dangerous drugs shall be examined in accordance with the following:
each outside shipping container shall be visually examined for identity and to
prevent the acceptance of contaminated dangerous drugs or dangerous 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.
||Each outgoing shipment shall be visually examined for
identity and to prevent the shipping of contaminated dangerous drugs or
dangerous 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.
damaged, and adulterated, dangerous drugs shall be handled in the following
||Dangerous drugs that are damaged, deteriorated, misbranded,
or adulterated shall be quarantined and physically separated from other
dangerous drugs until they are destroyed or returned to the supplier.
dangerous drugs whose immediate or sealed outer or sealed secondary containers
have been opened or used shall be identified as such, and shall be quarantined
and physically separated from other dangerous drugs until they are either
destroyed or returned to the supplier.
||If the conditions
under which a dangerous drug has been returned cast doubt on the drug's safety,
identify, strength, quality, or purity, then 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, identity, strength, quality,
or purity, the drug 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.
logistics providers shall establish, maintain, and adhere to written policies
and procedures which shall be followed for the receipt, security, storage,
inventory, and distribution of dangerous drugs, including policies and
procedures for identifying, recording, and reporting losses or thefts in
accordance with rule 4729:6-3-02 of the Administrative Code, and for correcting all errors and inaccuracies in inventories. Third party logistics providers shall include in their written policies and procedures all of the following:
||A procedure to be followed for handling recalls and
withdrawals of dangerous drugs. Such procedure shall be appropriate to deal
with recalls and withdrawals due to:
initiated at the request of the food and drug administration or other federal,
state, or local law enforcement or other government agency, including the state
board of pharmacy;
||Any voluntary action by the manufacturer to remove
defective or potentially defective drugs from the market;
undertaken to promote public health and safety by replacing of existing
merchandise with an improved product or new package design.
procedure to ensure that third party logistics providers 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.
||A procedure to
ensure that any adulterated dangerous 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 adulterated
dangerous drugs. This documentation shall be maintained for three years after
disposition of the adulterated drugs.
employed in the distribution of dangerous drugs shall be required to have
appropriate education, experience and training to assume responsibility for
positions related to compliance with the requirements of this division of the
||Third party logistics providers shall operate in
compliance with applicable federal, state, and local laws, rules and
regulations. This shall include, but is not limited to, all applicable laws,
regulations and standards set forth by the United States food and drug
administration and the United States drug enforcement
||Third party logistics providers shall permit properly
identified and authorized state board of pharmacy agents and federal, state,
and local law enforcement officials to enter and inspect their premises and
delivery vehicles, and to audit records and written operating
||Third party logistics providers shall be subject to the
provisions of any applicable federal, state, or local laws, rules or
regulations that relate to dangerous drug salvaging or
||The state board of pharmacy shall be notified, in a
manner specified by the Board, of any new facilities, work or storage areas to
be constructed or utilized for dangerous drugs.
minimum standards shall apply to the storage and transportation methods
utilized by a third-party logistics provider for the storage, transportation
and delivery of dangerous drugs:
||A licensee is responsible for selecting common or
contract carriers which provide adequate security to guard against in-transit
||When distributing dangerous drugs through agents, a
licensee is responsible for providing and requiring adequate security to guard
against theft and diversion while the substances are being stored or handled by
the agent or agents.
Cite as Ohio Admin. Code 4729:6-11-01
Five Year Review (FYR) Dates:
Effective Dates: 04/01/2016, 02/15/2017