(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.