Lawriter - OAC - 4729:5-3-09. Occasional sale and drug transfers

4729:5-3-09. Occasional sale and drug transfers

(A) The term "occasional sale" as used in section 4729.51 of the Revised Code means a wholesale sale of a commercially manufactured dangerous drug to a person licensed in accordance with section 4729.52 of the Revised Code, terminal distributor of dangerous drugs or any entity or person exempted from licensure as a terminal distributor of dangerous drugs 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 as authorized in section 4729.51 of the Revised Code.
(B) The dosage units of all dangerous drugs distributed by the pharmacy pursuant to this rule shall not exceed five per cent of the total dosage units dispensed by the pharmacy during the same calendar year.
(C) The limits set forth in this rule do not apply to the following:
(1) A licensed terminal distributor of dangerous drugs as described in paragraph (A)(2) of this rule; and
(2) Pharmacies that are also licensed to conduct sales of dangerous drugs in accordance with section 4729.52 of the Revised Code.
(D) The requirements of this rule do not apply to the transfer of dangerous drugs pursuant to paragraph (E) of this rule.
(E) A licensed terminal distributor of dangerous drugs having more than one licensed location may transfer or deliver dangerous drugs from one licensed location to another licensed location owned by that terminal distributor if the license issued for each location is in effect at the time of the transfer or delivery. Such transfer or delivery includes either of the following:
(1) Intracompany sales, which includes any transaction or transfer between any division, subsidiary, parent or affiliated or related company under the common ownership and control.
(2) The sale, purchase, or transfer of a drug or an offer to sell, purchase, or transfer of a drug among hospitals or other health care entities that are under common control. Common control means the power to direct or cause the direction of the management and policies of a person or an organization, whether by ownership of stock, voting rights, by contract, or otherwise.
(F) Occasional sales by a licensed terminal distributor shall comply with the reporting requirements set forth in division 4729:8 of the Administrative Code.
(G) "Drug shortage," with respect to an occasional sale, means a drug on the United States food and drug administration's drug shortage list that is not commercially available regardless of the reason that the drug is not available, including the absence of a manufacturer for the drug or the lack of a readily available supply of the drug from a manufacturer or wholesaler.

Cite as Ohio Admin. Code 4729:5-3-09

History. Effective: 3/1/2019
Five Year Review (FYR) Dates: 03/01/2024
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28
Rule Amplifies: 4729.51, 4729.541