61N-1.007. Compressed Medical Gases

(1) Each compressed medical gases manufacturer or medical oxygen retailer who manufactures or refills compressed medical gases must comply with the current good manufacturing practice regulations for drug products promulgated by the FDA in 21 C.F.R. Parts 200-299 and the “Compressed Medical Gases Guideline” issued by the Center for Drug Evaluation and Research, FDA in February 1989, which are incorporated by reference herein. Deviations from these requirements authorized in writing by the FDA will be recognized by the department when determining compliance with current good manufacturing practices for compressed medical gases.

(2) Each compressed medical gases manufacturer or medical oxygen retailer that refills tanks must establish and follow detailed written procedures covering: production and process controls; training; prefill, fill and post-fill operations; analytical testing; labeling procedures; calibration and maintenance of equipment; distribution; testing and approval or rejection of drug product containers and closures; recall procedures; recordkeeping; and complaint files.

(3) Labels and Labeling. In those instances where the FDA has not promulgated a final regulation related to labeling of a compressed medical gas, the label must include the general requirements of: name and address of the manufacturer or distributor; established name of the gas; contents in terms of the volume of gas in liters or cubic feet at specified temperature and 1 atmosphere of pressure; lot number; statement of ingredients (for mixtures); directions for use statement; applicable warning statements; and the prescription statement. Although oxygen intended to treat a medical condition is regarded as a prescription drug, the FDA has not objected to emergency use oxygen being marketed without a prescription. If Oxygen U.S.P. is sold for emergency use, then the label is required to contain the statement: “For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, prescription statement”. The prescription statement is “Rx Only” or the prescription symbol followed by the word “Only.” All prescription medical oxygen must also include the following:

(a) If the container is disposable, the label must bear the statement “Disposable Container. Federal Law Prohibits Refilling. Do Not Puncture or Discard Container into Fire or Incinerator.”

(b) If the container is non-disposable and may be refilled, the label must bear the statement “Federal Law Requires that this Container be Refilled with Oxygen U.S.P. Only by Establishments Registered as a Drug Producer in accordance with the Federal Food, Drug, and Cosmetic Act.”

(c) A statement whether the oxygen was produced by the air-liquefaction process;

(d) The warning statement shall be: “Warning – uninterrupted use of high concentrations of oxygen for more than five hours may be harmful. Do not attempt to use on patients who have stopped breathing, unless used in conjunction with resuscitative equipment. Keep Out of Reach of Children. Contents under high pressure and can vigorously accelerate combustion. Keep free from oil and grease. Do not use or store near heat or open flame and use only with equipment conditioned for oxygen service.”

Rulemaking Authority 499.05, 499.012(2)(b) FS. Law Implemented 499.006, 499.007, 499.012, 499.0122, 499.013 FS. History–New 7-1-96, Formerly 10D-45.0442, Amended 1-26-99, 1-1-04, Formerly 64F-12.007.