Ohio Administrative Code
Title 4729:5 - Dangerous Drugs
Chapter 4729:5-7 - Charitable Pharmacies
Section 4729:5-7-03 - Persons eligible to transfer sample drugs to a charitable pharmacy
Universal Citation: OH Admin Code 4729:5-7-03
Current through all regulations passed and filed through September 16, 2024
(A) An eligible sample drug shall only be transferred directly to a charitable pharmacy by any of the following:
(1) A manufacturer licensed
in accordance with section
4729.52 of the Revised Code,
including a representative of the manufacturer;
(2) A person licensed in accordance with
section 4729.52 of the Revised Code
acting on behalf of a manufacturer; or
(3) A prescriber practicing at a location
that is licensed as a terminal distributor of dangerous drugs, unless exempt
from licensure pursuant to section
4729.541 of the Revised
Code.
(B) If a sample drug is transferred by a prescriber:
(1) A
record must be created by the prescriber documenting the transfer. The record
shall contain the:
(a) Name and address of the
supplying prescriber;
(b) Name,
strength, and quantity of the sample drug being transferred;
(c) Date of the sample drug transfer;
and
(d) Name and address of the
charitable pharmacy receiving the sample drug.
(2) A copy of all required records
documenting the transfer of a sample drug shall be kept by the prescriber and
the charitable pharmacy for a minimum of three years and shall be stored in a
readily retrievable manner.
(3) The
prescriber shall not transfer a sample drug to a charitable pharmacy unless the
sample drug was received directly from a manufacturer, a manufacturer's
representative, or by a person licensed in accordance with section
4729.52 of the Revised Code
acting on behalf of a manufacturer.
(4) The sample drug complies with the
requirements of rule
4729:5-7-04 of the
Administrative Code.
(5) The sample
drug must not have any physical signs of tampering.
(6) The sample drug packaging must not have
any physical signs of tampering.
(C) Nothing in this rule prohibits the donation of a sample drug to a charitable pharmacy operating as a drug repository in accordance with Chapter 4729:5-10 of the Administrative Code.
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