Lawriter - OAC - 4729:5-7-03 Persons eligible to transfer sample drugs to a charitable pharmacy.

4729:5-7-03 Persons eligible to transfer sample drugs to a charitable pharmacy.

(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.

Replaces: 4729-36-04


Effective: 7/1/2019
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