R.C. 4729:5-17-03 - Nitrous oxide - general provisions

(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. Each person, whether located within or outside of this state, who conducts retail sales of nitrous oxide in this state shall obtain a limited category II terminal distributor of dangerous drugs license.

The requirements of this paragraph do not apply to persons currently licensed to purchase, possess, and sell dangerous drugs at retail in accordance with division 4729:5 of the Administrative Code or who are exempted from licensure in accordance with section 4729.541 of the Revised Code.

(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 accordance with the requirements of division 4729:5 of the Administrative Code.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 retail sellers of nitrous oxide shall maintain records of the purchase of nitrous oxide at wholesale and the sale of nitrous oxide at retail 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.

Notes

R.C. 4729:5-17-03

Effective: 5/1/2025
Five Year Review (FYR) Dates: 11/26/2024 and 05/01/2030
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, 09/01/2019