FDA to phase out CFCs in metered-dose inhalers for epinephrine

The US Food and Drug Administration has proposed a change to its regulation on the use of chlorofluorocarbons, or CFCs, in metered-dose inhalers (MDIs) for epinephrine. The rule would remove the "essential-use" designation that allows the use of CFCs in these medical devices. Epinephrine MDIs are used for the temporary relief of occasional symptoms of mild asthma.

The FDA has tentatively concluded that there are no substantial technical barriers to formulating epinephrine as a product that does not release CFCs. Under the proposed rule, epinephrine MDIs containing CFCs would be removed from the market by the end of 2010. A 60-day public comment period will commence following publication of the proposed rule in the Federal Register, and an open public meeting on the essential use of epinephrine will be held on a date to be announced later.

The production of CFCs is being phased out worldwide under the terms of an international agreement called the Montreal Protocol on Substances that Deplete the Ozone Layer. Most MDIs available in the USA once contained CFCs, however, most such products have recently been or are being reformulated to use other substances as propellants.