4729-36-04 Sample drug distribution to a charitable pharmacy.

(A) An eligible sample drug shall only be distributed directly to a charitable pharmacy by a:

(1) Manufacturer;

(2) Manufacturer's representative;

(3) Wholesale distributor of dangerous drugs acting on behalf of a manufacturer; or

(4) Prescriber practicing in a location that is licensed as a terminal distributor of dangerous drugs unless exempt from licensure pursuant to sections 4729.51 and 4729.541 of the Revised Code.

(B) If a sample drug is furnished by a prescriber:

(1) A record must be created by the prescriber documenting the sample drug transfer. The record shall contain the:

(a) Name and address of the supplying prescriber;

(b) Name, strength, and quantity of the sample drug supplied;

(c) Date of the sample drug transfer;

(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 must be kept by the prescriber and the charitable pharmacy for a minimum of three years and 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 wholesaler acting on behalf of a manufacturer and meets the eligibility requirements pursuant to rule 4729-36-05 of the Administrative Code.

(4) The sample drug must not have any physical signs of tampering.

(5) The sample drug packaging must not have any physical signs of tampering.

Effective: 01/01/2011
R.C. 119.032 review dates: 09/30/2010 and 12/01/2015
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: 1/1/06, 10/19/07