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U.S. Department of Health and Human Services

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Letter Regarding Phase-out of Epinephrine CFC MDIs

U.S. Food and Drug Administration
Office of Special Health Issues
5600 Fishers Lane, HF-12
Rockville, Maryland 20857
Phone:  301-827-4460

Dear Colleague,

We are writing to inform you that after December 31, 2011, epinephrine CFC metered-dose inhalers will not be made or sold.

As background:

On November 19, 2008, the U.S. Food and Drug Administration published a final rule that makes a change to one of our regulations (21 CFR 2.125). The rule removes the “essential-use” designation for epinephrine administered in oral pressurized metered-dose inhalers. These inhalers use chlorofluorocarbons (CFCs) as a propellant.  The rule will effectively bar the production, marketing and sale of epinephrine CFC inhalers after December 31, 2011, because CFCs harm the environment.

This date gives patients time to consult with health care professionals and switch to other medicines to treat their asthma. Currently, there is no FDA-approved over-the-counter epinephrine inhaler that doesn’t contain CFCs. Although the phase out date for epinephrine CFC inhalers is December 31, 2011, we are taking this opportunity to convey this information, so that patients and health care providers can plan accordingly and develop an effective asthma management and treatment plan to prevent and control asthma symptoms and reduce airway inflammation.

A questions and answers sheet with more information for patients and health care professionals about the final rule and phase out of epinephrine CFC inhalers can be found at: Epinephrine CFC Metered-dose Inhalers - Questions and Answers.

Link to the final rule: http://edocket.access.gpo.gov/2008/E8-27436.htm

Thank you for your continuing support of FDA's mission.  If you have questions, please feel free to contact us.

Sincerely,