(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.
