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Ohio Administrative Code (Last Updated: January 12, 2021) |
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4729 State Board of Pharmacy |
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Chapter4729-36. Charitable Pharmacy |
4729-36-04. Sample drug distribution to a charitable pharmacy [RESCINDED]
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(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.