4729-9-10 Occasional sale.

The term "occasional sale" as used in section 4729.51 of the Revised Code means a wholesale sale of a drug by a pharmacist who is a terminal distributor of dangerous drugs or is employed by a terminal distributor of dangerous drugs and the buyer shall be a ny of the following: wholesale distributor of dangerous drugs, terminal distributor of dangerous drugs, prescriber as defined in section 4729.01 of the Revised Code, or any entity exempted from licensure as a terminal distributor of dangerous drugs pursuant to section 4729.51 of the Revised Code.

The total value of all dangerous drugs distributed by the terminal distributor of dangerous drugs pursuant to this rule shall not exceed five per cent of the total value of dangerous drugs purchased by the terminal distributor of dangerous drugs during the same calendar year. In addition, the total amount of controlled substances sold pursuant to this rule shall not exceed the allowable amount as specified in 21 C.F.R. 1307.11(3/16/2016).

The value of the dangerous drugs shall be based on the cost of the dangerous drugs to the terminal distributor of dangerous drugs.

The limits set forth in this rule do not apply to terminal distributors of dangerous drugs that conduct occasional sales of naloxone at wholesale to a state or local law enforcement agency.

The limits set forth in this rule do not apply to pharmacies that conduct occasional sales of naloxone at wholesale.

Effective: 6/30/2016
Five Year Review (FYR) Dates: 03/18/2016 and 06/30/2021
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.51
Prior Effective Dates: 4/1/65, 3/19/87, 7/1/93, 3/1/99