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U.S. Department of Health and Human Services


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Educating the Public About Removal of Essential-Use Designation for Epinephrine

The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) held a public workshop on September 25, 2009 in Rockville, MD to discuss strategies for educating the public about the phase-out of chlorofluorocarbon (CFC)-propelled over-the-counter (OTC) epinephrine inhalers from the US market. The one day workshop solicited input from key stakeholders in the asthma community, the pharmaceutical industry, experts in health care communication, and the public about how best to alert patients and transition them to therapeutic alternatives.

OTC epinephrine metered-dose inhalers are FDA-approved for the temporary relief of shortness of breath, tightness in the chest, and wheezing due to asthma. But the medicine in these inhalers is currently propelled by gases known as chlorofluorocarbons (CFCs). CFCs are harmful to the environment because they decrease the protective ozone layer above the Earth. In order to comply with an international agreement, the Montreal Protocol on Substances that Deplete the Ozone Layer, CFC-propelled epinephrine OTC inhalers cannot be made or sold in the United States after December 31, 2011.