Ohio Admin. Code 4729:6-5-02 - Wholesale distributors - recordkeeping
(A) Wholesale 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.
(1) The
records shall include, but not be limited to, the following information:
(a) The source of the drugs, including the
name and principle
principal address of the seller or transferor, and the
address of the location from which the drugs were shipped.
(b) The name, national drug code, quantity of
the drugs received, distributed, sold, disposed,
or returned.
(c) The dates of
receipt, sale, and distribution of the
drugs.
(d) The name and
principle
principal address of the purchaser or receiver and the
address of the location where the drugs were shipped.
(e) 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.
(2)
All records maintained in accordance with this rule 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 five years following disposition of the
drugs.
(3) 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.
(4) A wholesale
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.
(B) The recordkeeping requirements in
paragraph (A) of this rule shall be followed for all damaged, deteriorated,
misbranded, or adulterated dangerous drugs.
(C) Wholesale distributors shall submit
wholesale sale information to the drug database in accordance with section
4729.78 of the Revised
Code.
Notes
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 4729.53
Prior Effective Dates: 03/01/2019, 03/01/2021
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