(A) The term "occasional sale" as used in section 4729.51 of the Revised Code means a wholesale sale to a wholesale distributor of dangerous drugs, terminal distributor of dangerous drugs or any entity or person exempted from licensure as a terminal distributor of dangerous drugs pursuant to section 4729.541 of the Revised Code by either:
(1) A pharmacy licensed as a terminal distributor of dangerous drugs; or
(2) A licensed terminal distributor of dangerous drugs that is not a pharmacy, but only with respect to naloxone.
(B) 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).
(1) The value of the dangerous drugs shall be based on the cost of the dangerous drugs to the terminal distributor of dangerous drugs.
(C) The limits set forth in this rule do not apply to terminal distributors of dangerous drugs that conduct occasional sales of naloxone at wholesale.
Five Year Review (FYR) Dates: 09/15/2022
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.51, 4729.541
Prior Effective Dates: 4/1/65, 3/19/87, 7/1/93, 3/1/99, 10/27/11, 6/30/16