Brokers - general operations
The following requirements shall apply
to all persons licensed as a wholesale distributor of dangerous drugs with a
||Brokers shall establish and maintain records of all
transactions regarding the transfer, sale or other disposition of dangerous
records shall include, but shall not be limited to, the following
||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.
||The name, national drug code and quantity of the drugs
received, distributed, sold, disposed or returned.
||The dates of
receipt, sale and distribution of the drugs.
||The name and
principle address of the purchaser or receiver and the address of the location
where the drugs were shipped.
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.
||Brokers 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 by in a manner determined by the board. Any such alternate
location shall be secured and accessible only to representatives or contractors
of the broker.
||A broker 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
||Brokers shall only engage in the marketing, offering,
or contracting for wholesale distribution and sale of dangerous drugs that are
unopened (i.e. no partial stock bottles) and packaged in the manufacturer's
||Brokers shall operate in compliance with all applicable
federal, state, and local laws, rules and regulations.
permit properly identified and authorized state board of pharmacy agents,
federal, state, and local law enforcement officials to enter and inspect their
premises and delivery vehicles, and to audit records and written operating
||A broker seeking to engage in activities relating to
the distribution of dangerous drugs other than those of a broker shall obtain
additional licensure for the operations conducted pursuant to those
||Brokers shall verify that the seller and buyer are
appropriately licensed or exempt from licensure in accordance with rule 4729:6-3-04 of the Administrative Code.
||Brokers shall not
engage in the marketing, offering, or contracting for wholesale distribution
and sale of dangerous drugs that are controlled substances.
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.
Cite as Ohio Admin. Code 4729:6-7-01
Five Year Review (FYR) Dates:
Effective Dates: 05/12/2017