Current through all regulations passed and filed through March 18, 2024
The following requirements shall apply
to all persons licensed as outsourcing facilities:
(A)
All facilities
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 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;
(4)
Be maintained in
a clean and orderly condition;
(5)
Be free from
infestation by insects, rodents, birds, or vermin of any kind;
(6)
Shall be
registered as a business entity with the appropriate state or local
authority(s) and must operate out of a location that is zoned for commercial
use and not out of a residence or personal dwelling.
(B)
Adulterated drugs shall be stored in a separate and secure
area apart from the storage of drugs used for compounding, distribution and
sale.
(1)
Adulterated drugs 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.
(2)
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 3715.88 to
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.
(3)
Dangerous drugs
that are controlled substances shall be disposed of pursuant to rule
4729:6-3-01
of the Administrative Code.
(C)
All outsourcing
facilities shall be secure from unauthorized entry.
(1)
Access from
outside the premises shall be kept to a minimum and be well controlled.
(2)
The
outside perimeter of the premises shall be well lit.
(3)
Entry into areas
where dangerous drugs are stored shall be limited to authorized
personnel.
(4)
All facilities where dangerous drugs are stored shall
be equipped with an alarm system to detect unauthorized entry after
hours.
(5)
All facilities 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.
(D)
All
dangerous 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).
(1)
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.
(2)
Appropriate manual, electromechanical, or electronic
temperature and humidity recording equipment, devices, and/or logs shall be
utilized to document proper storage of dangerous drugs.
(E)
All
shipments of dangerous drugs shall be examined in accordance with the
following:
(1)
Upon receipt, 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.
(2)
Each outgoing
shipment shall be carefully inspected for identity of the dangerous drug
products and to ensure that there is no delivery of dangerous drugs that have
been damaged in storage or held under improper conditions.
(F)
All
returned, damaged, and adulterated, dangerous drugs shall be handled in the
following manner:
(1)
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.
(2)
Any 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.
(3)
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.
(G)
Outsourcing facilities 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. Outsourcing facilities shall include in their written policies and
procedures all of the following:
(1)
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:
(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 state
board of pharmacy;
(b)
Any voluntary action by the outsourcing facility to
remove defective or potentially defective drugs from the market;
(c)
Any
action undertaken to promote public health and safety by replacing existing
merchandise with an improved product or new package design.
(2)
A
procedure to ensure that outsourcing facilities 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.
(3)
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.
(H)
Personnel
employed in the compounding, manufacturing and 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 Administrative Code.
(I)
Outsourcing
facilities 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
administration.
(J)
Outsourcing facilities 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 their records and written operating
procedures.
(K)
Outsourcing facilities shall be subject to the
provisions of any applicable federal, state, or local laws, rules or
regulations that relate to dangerous drug salvaging or
reprocessing.
(L)
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 in this state.
(M)
The following
minimum standards shall apply to the storage and transportation methods
utilized by an outsourcing facility for the storage, transportation and
delivery of dangerous drugs:
(1)
A licensee is responsible for selecting common or
contract carriers which provide adequate security to guard against in-transit
losses.
(2)
When storing dangerous drugs in a public warehouse, a
licensee is responsible for selecting a facility which will provide adequate
security to guard against storage losses. The licensee shall store controlled
substances in a public warehouse which complies with the requirements set forth
in section 1301.72 of the code of federal regulations (2/28/2018). In addition,
the licensee shall employ precautions (e.g., assuring that shipping containers
do not indicate that contents are controlled substances) to guard against
storage or in- transit losses.
(3)
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. (N) An
outsourcing facility shall comply with all labeling requirements pursuant to
section 503B of the Federal Food, Drug, and Cosmetic Act (5/28/2015).
(N)
An outsourcing facility shall comply with current good
manufacturing practices pursuant to Section 501 of the Federal Food, Drug and
Cosmetic Act (5/28/2015).
(O)
If an entity licensed as an outsourcing facility sells
or dispenses patient specific drugs, it must also maintain licensure as a
terminal distributor of dangerous drugs. All laws and rules applicable to
licensure as a terminal distributor of dangerous drugs shall apply to the
dispensing of patient specific drugs.
Replaces: 4729-16-02