(A) Each person located within this state who seeks to purchase and possess nitrous oxide for the purpose of using it as a direct ingredient in food pursuant to Title 21 CFR 184.1545 (04/1/2018) shall obtain a limited category II terminal distributor of dangerous drugs license.
(B) All areas where nitrous oxide is stored shall be maintained in a clean and orderly condition. Storage areas shall be maintained at temperatures and conditions which will ensure the integrity of the nitrous oxide prior to use as stipulated by the manufacturer's or distributor's labeling.
(C) Nitrous oxide shall be secured in a tamper-evident manner to deter and detect unauthorized access.
(D) All food processors and retail sellers of food licensed in accordance with this rule shall maintain records of purchase at wholesale and use in the processing food for three years at the licensed location. All records shall be readily retrievable.
(1) A terminal distributor intending to maintain records at a location other than the location licensed by the state board of pharmacy must notify the board in a manner determined by the board.
(2) Any such alternate location shall be secured and accessible only to authorized representatives or contractors of the terminal distributor of dangerous drugs.
(E) A terminal distributor of dangerous drugs shall report the theft or significant loss of nitrous oxide pursuant to rule 4729:5-3-02 of the Administrative Code.
Replaces: 4729-25-01, 4729-25-02, 4729-25-03, 4729-25-04
Five Year Review (FYR) Dates: 09/01/2024
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.51, 4729.54, 4729.55
Prior Effective Dates: 08/16/1994 (Emer.), 11/25/1994, 05/24/2015