Florida Administrative Code › 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION › 61N - Drugs, Devices and Cosmetics › Chapter 61N-1 - REGULATIONS FOR DRUGS, DEVICES AND COSMETICS › Section 61N-1.007 - Compressed Medical Gases

Current through Reg. 50, No. 138; July 16, 2024
(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."