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.

Five Year Review (FYR) Dates: 10/20/2015 and 10/01/2020
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, 01/01/2011