CFCphaseout Inhaler phaseout approaching OTC epinephrine metered-dose inhalers with CFCs no longer available after December Primatene Mist, the only OTC asthma inhaler marketed in the United States, will no longer be available after December 31, 2011. Primatene Mist is an epinephrine metered-dose inhaler (MDI) with (CFCs). Epinephrine is a short-acting adrenergic bronchodilator used for the temporary relief of occasional symptoms of In a proposed rule published on September 20, 2007 (72 FR 53711), an effective date of December 31, 2010, was proposed for removal of the essential-use designation for OTC epinephrine MDIs. Comments on this proposed effective date were solicited. The rule published on November 19, 2008, removed the essential-use designation of OTC epinephrine MDIs with CFCs: Primatene Mist MDIs with CFCs will no longer be available after December 31, 2011. Thus, OTC epinephrine MDI users may need to transition to therapeutic alternatives that contain a different active moiety, such as prescription albuterol MDIs. FDA urges patients who use Primatene Mist MDIs to see a health professional soon to switch to another asthma medication. Replacement medications for Primatene Mist MDIs may cost more than the OTC inhaler. Pharmacists can recommend that patients contact the drug company that makes the prescribed drug to out if the company has a patient-assistance program that makes medications available to patients at low or no cost. In addition, patients can contact the Partnership for Prescription Assistance by calling 888-477-2669 or visiting www.pparx.org. Still have questions? mild asthma. Epinephrine MDIs were previously marketed as generic brands for certain retail pharmacies. The phaseout of epinephrine MDIs with CFCs is part of an international agreement to stop the use of substances that damage the environment. Background Under the Montreal Protocol on Substances that Deplete the Ozone Layer (Montreal Protocol) and the Clean Air Act,1 FDA, in consultation with the Environmental Protection Agency (EPA), is required to determine whether an FDAregulated product that releases an ozonedepleting substance (ODS) is an essential use of the ODS. Products containing an ODS, such as CFCs, that are not designated as essential uses cannot be sold or distributed in the United States. 36 PHARMACY TODAY MAY 2011 and barred the production, marketing, and sale of epinephrine CFC inhalers after December 31, 2011. The 1-year extension provided additional time to disseminate information about the transition to OTC epinephrine CFC MDI users and allows consumers more time to transition to appropriate non-CFC alternatives. Education is key are many other safe and effective medications to treat the symptoms of said Badrul Chowdhury, MD, PhD, Director of Division of Pulmonary, Allergy, and Rheumatology Products. all breathing problems are asthma, so it is important to get an accurate diagnosis and the proper Pharmacists should be aware of the following key facts related to the phaseout To learn more about the phaseout of CFC-propelled epinephrine inhalers, a consumer article, podcast, and question and answer sheet can be found on website at www.fda.gov/Drugs/ DrugSafety/InformationbyDrugClass/ ucm193304.htm. The question and answer sheet and consumer article, which may be helpful for educating patients, are available in English and Spanish. The consumer article is also available in Chinese. For additional information and answers to frequently asked questions, you can also visit the EPA website at www.epa.gov./ozone/title6/exemptions/ inhalers.html. ?Beth F. Fritsch, BPharm, MBA Contributing writer Beth F. Fritsch, BPharm, MBA, is Health Programs Coordinator for of Special Health Issues. Reference 1. Montreal Protocol on Substances that Deplete the Ozone Layer, September 16, 1987, 26 I.L.M. 1541 (1987); 1990 Amendments to the Clean Air Act, Public Law No. (November 15, 1990). www.pharmacytoday.org