(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.
Five Year Review (FYR) Dates: 07/01/2024
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26, 3719.811
Rule Amplifies: 3719.81 , 3719.811 , 3719.812, 3719.813
Prior Effective Dates: 01/01/2006, 10/19/2007, 01/01/2011