PURPOSE: This rule establishes standards of operation for medical gas distributors. This proposed rule has been reviewed by the Drug Distributor Advisory Committee as required by section 338.140.4, RSMo. (1) Medical gases are defined as compressed gases and liquid gases that a distributor or manufacturer has labeled for medical use in compliance with federal law. (2) Medical gas distributor is defined as an entity which is licensed by the board as a drug distributor and is involved in the distribution of medical gases and related medical devices pursuant to a medical gas order to medical gas suppliers and other entities that are registered, licensed or permitted to use, administer or distribute medical gases. (3) Medical gas distributors that are not involved in the storage or transfer of any AND INSURANCE Division 2220—State Board of Pharmacy

other federal legend drugs and only store, transfer or transfill medical grade gas products other than nitrous oxide are exempt from the following regulation sections: 20 CSR 2220-5.030(3)(B); (3)(C)4., 9., 12., and 13.; (3)(E); and (3)(M)4. Medical gas distributors that store, transfer or transfill nitrous oxide are exempt from 20 CSR 2220-5.030(3)(B); (3)(C)4. and 9.; (3)(E) and (3)(M)4. All other drug distributor requirements contained within the board’s regulations shall be considered applicable to medical gas distributors.

1. (4) A medical gas distributor that is involved in the manufacture/transfilling of medical gases must register with the Food and Drug Administration (FDA) as a medical gas manufacturer and comply with the drug listing requirements of the federal act. In addition, all current good manufacturing practice requirements as set forth in 21 CFR 210 through 211 must be complied with.

AUTHORITY: sections 338.050, 338.333, 338.335, 338.337, and 338.340, RSMo 2000.* This rule originally filed as 4 CSR 220-5.070. Original rule filed March 15, 2000, effective Sept. 30, 2000. Moved to 20 CSR 2220-5.070, effective Aug. 28, 2006. Amended: Filed Feb. 6, 2008, effective Aug. 30, 2008. *Original authority: 338.050, RSMo 1939, amended 1949, 1961, 1971, 1981; 338.333, RSMo 1989; 338.335, RSMo 1998; 338.337, RSMo 1989; and 338.340, RSMo 1989.