Wholesale distributors - recordkeeping
distributors of dangerous drugs shall establish and maintain inventories and
records of all transactions regarding the receipt, sale and distribution or
other disposition of dangerous drugs.
||The records shall
include, but not be limited to, the following information:
||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
||The name, national drug code, 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.
||A 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.
||Wholesale distributors 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.
distributor 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.
recordkeeping requirements in paragraph (A) of this rule shall be followed for
all damaged, deteriorated, misbranded, or adulterated dangerous drugs.
||Wholesale distributors shall submit wholesale sale
information to the drug database in accordance with section
4729.78 of the Revised
Cite as Ohio Admin. Code 4729:6-5-02
Five Year Review (FYR) Dates: