Ohio Admin. Code 4729:6-11-02 - Third-party logistics providers - recordkeeping
(A)
Third
party
Third-party logistics providers
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, and 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)
Third party
Third-party logistics providers located in this state
intending to maintain records at a location other than the place licensed by
the state board of pharmacy must obtain approval from the board in a manner
determined by the board. Any such alternate location shall be secured and
accessible only to representatives or contractor
contractors
of the third party
third-party logistics provider.
(B) The recordkeeping requirements in
paragraph (A) of this rule shall be followed for all damaged, deteriorated,
misbranded, or adulterated dangerous drugs.
Notes
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28
Rule Amplifies: 4729.52
Prior Effective Dates: 03/01/2019, 03/01/2021
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