US FDA sets deadline for removal of CFC epinephrine inhalers
This article was originally published in RAJ Devices
Executive Summary
The US Food and Drug Administration has set a deadline of 31 December 2011 for manufacturers to take over-the-counter epinephrine metered-dose inhalers containing chlorofluorocarbons off the market. The cut-off date in the final rule on use of ozone-depleting substances; removal of essential-use designation (epinephrine)1 is a year later than the one suggested in the proposed rule that the FDA issued in September 20072,3. This will give manufacturers and users enough time for a properly informed transition to non-CFC alternatives such as prescription albuterol/levalbuterol MDIs that use hydrofluoroalkanes (HFA) as a propellant, the agency believes.