FDA proposes chlorofluorocarbon (CFC) removal from epinephrine inhalers.
The FDA has proposed a new regulation to phase out the use of chlorofluorocarbons (CFCs) in inhalers containing epinephrine. According to the agency, no technical barriers exist that would prevent epinephrine from being reformulated without the ozone-depleting ingredient and the CFC-containing inhalers would be removed from the market by the end of 2010. A 60-day period for public comment will commence following publication of the proposed rule in the Federal Register. In addition, an open public meeting on the issue will be held at a date to be announced. Under the Clear Air Act, CFCs are permitted only in medical products determined to be essential by the FDA. Should the change go through, epinephrine would no longer carry its "essential-use" designation.
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