The FDA is proposing a ban on using chlorofluorocarbons (CFCs) in metered-dose inhalers (MDIs) for epinephrine.
The move could remove the “essential use” designation that permits CFCs in these medical devices.
Epinephrine MDIs are used for temporary relief of occasional symptoms of mild asthma.
But the FDA has concluded that there are no substantial technical barriers to making the products CFC-free.
Under the proposed rule, epinephrine MDIs containing CFCs will be removed from the market in the USA by the end of 2010.
CFC production is being phased out worldwide under the terms of an international agreement, the Montreal Protocol on Substances that Deplete the Ozone Layer.
Most MDIs available in the USA used to contained CFCs, but most devices have now been reformulated to use other substances as propellants.
MDIs for epinephrine are currently marketed over the counter, and should this rule become final, users will have to obtain a prescription for alternative products if an epinephrine inhaler without CFCs does not exist by 2010.
A 60-day public consultation period will start once the proposed changes are published, and public meetings will be held on the alterations at a later date.
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