Virtual wholesalers - general operations
The following requirements shall apply
to all persons licensed as a wholesale distributor of dangerous drugs with a
virtual wholesaler classification:
wholesalers shall establish and maintain inventories and records of all
transactions regarding the receipt, sale and distribution or other transfer of
||The records shall include, but not be limited to, the
||The source of the drugs, including the name and
principle address of the seller or transferor, and the address of the location
from which the drugs were shipped.
national drug code, quantity of the drugs received, distributed, sold, disposed
||The dates of receipt, sale and distribution of the
||The name and principle address of the purchaser or
receiver and the address of the location where the drugs were shipped.
system of records and procedures shall be maintained which prevent the sale or
other distribution of dangerous drugs to any person not authorized in
accordance with section
4729.51 of the Revised Code.
Such procedures and records shall meet the requirements set forth in rule 4729:6-3-04 of the Administrative Code.
maintained in accordance with this division shall be made readily retrievable
for inspection and copying by properly identified and authorized state board of
pharmacy agents and federal, state, or local law enforcement agency officials
for a period of three years following disposition of the drugs.
||Virtual wholesalers located in this state intending to
maintain records at a location other than the place licensed by the state board
of pharmacy must notify the board in a manner determined by the board. Any such
alternate location shall be secured and accessible only to representatives or
contractors of the wholesale distributor.
wholesaler maintaining records at location other than the location licensed by
the state board of pharmacy or via a computerized recordkeeping system shall
maintain an executed agreement with the company possessing or storing the
records authorizing an agent of the board access to the records maintained in
accordance with this division within three business days.
||Virtual wholesalers 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. At a minimum, virtual wholesalers shall include in their written policies and procedures with all the following:
||A procedure to be followed for handling recalls and
withdrawals of dangerous drugs. Such procedure shall address recalls and
withdrawals due to:
||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;
action by the manufacturer to remove defective or potentially defective drugs
from the market;
||Any action undertaken to promote public health and
safety by replacing of existing merchandise with an improved product or new
||A procedure to
ensure that virtual wholesalers 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 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.
||Virtual wholesalers 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.
wholesalers 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 procedures.
wholesalers 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.
wholesalers shall submit wholesale sale information to the drug database in
accordance with section
4729.78 of the Revised
||The following minimum standards shall apply to the
storage and transportation methods utilized by virtual wholesalers 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 losses.
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
||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.
wholesaler seeking to engage in any other activities relating to the
distribution of dangerous drugs shall obtain additional licensure for the
operations conducted pursuant to those rules.
Cite as Ohio Admin. Code 4729:6-6-01
Five Year Review (FYR) Dates:
Effective Dates: 04/01/2016, 02/15/2017