The following requirements shall apply to all persons licensed
as a wholesale distributor of dangerous drugs:
(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
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 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)
(B)(3) 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.
(a) 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)
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)(4) Dangerous drugs
that are controlled substances shall be disposed of pursuant to rule
4729:6-3-01 of the
Administrative Code.
(C)
All facilities used for wholesale drug distribution 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 regularly 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
five
years from the last documented temperature and humidity reading.
(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 expired
dangerous drugs shall be handled in the following manner:
(1) Dangerous drugs that are expired,
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
where the 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
identity, 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) Wholesale drug distributors
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.
Wholesale drug distributors shall include in their written
policies and procedures with all 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 manufacturer to remove defective or potentially defective drugs from the
market;
(c) Any action undertaken
to promote public health and safety by replacing of existing merchandise with an improved product or
new package design.
(2)
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.
(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
five years after
disposition of the adulterated drugs.
(H) Personnel employed in the wholesale
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) Wholesale drug distributors 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) Wholesale drug distributors shall permit
properly identified and authorized state board of pharmacy
agents
employees and federal, state, and local law
enforcement officials to enter and inspect their premises and delivery
vehicles, and to audit records and written operating procedures.
(K) Wholesale drug distributors 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 a
wholesale distributor of dangerous drugs 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
21 CFR
1301.72 (10/3/2023)
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
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.