Drugs
Phase-Out of CFC Metered-Dose Inhalers
Metered dose inhalers (MDIs) that contain chlorofluorocarbons (CFCs) are being phased out. Manufacturers use CFCs as propellants to move the medicine out of the inhaler so patients can breathe the medicine into their lungs. CFCs are harmful to the environment because they decrease the protective ozone layer above the Earth. The United States, along with most other countries, are eliminating CFCs because of an international agreement, called Montreal Protocol on Substances that Deplete the Ozone Layer.
Many manufacturers have reformulated or are reformulating their inhalers so they don’t contain CFCs. Most CFC inhalers already have been phased out. The CFC inhalers that are still available are scheduled to be phased out in the coming years.
Patients will need to talk to their health care professionals and switch to another medicine before the phase-out of their CFC inhalers is completed.
General Information
Primatene Mist With Chlorofluorocarbons No Longer Available After Dec. 31, 2011
FDA Consumer Update article (3/16/2011)Drug Treatments for Asthma and Chronic Obstructive Pulmonary Disease that Do Not Use Chlorofluorocarbons Montreal Protocol on Substances that Deplete the Ozone Layer
Montreal Protocol, September 16, 1987, S. Treaty Doc. No. 10, 100th Cong., 1st session, 26 I. L. M. 1541 (1987)International and Clean Air Act Information Regarding the U.S. Elimination of the Use of Ozone-Depleting Substances, Including Chlorofluorocarbons Metered Dose Inhalers: The Transition to Ozone-Safe Propellants
Environmental Protection AgencyEPA Clean Air Act
Environmental Protection AgencyInternational Pharmaceutical Aerosol Consortium (IPAC)
Provides links to resources that discusses upcoming changes to MDIs.
Regulatory Documents
Direct Final Rule for Use of Ozone-Depleting Substances; Essential-Use Determinations
(December 7, 2006) (Removal of beclomethasone, dexamethasone, fluticasone, bitolterol, salmeterol, ergotamine tartrate, and ipratropium bromide used in oral pressurized metered-dose inhalers)Direct Final Rule for Use of Ozone-Depleting Substances; Essential-Use Determinations-pdf Final Rule for Use of Ozone-Depleting Substances; Essential-Use Determinations
(July 24, 2002)Final Rule for Use of Ozone-Depleting Substances; Essential-Use Determinations [PDF] Proposed Rule for Use of Ozone-Depleting Substances Essential Use Determinations
(September 1, 1999)Proposed Rule for Use of Ozone-Depleting Substances Essential Use Determinations [PDF] Advance Notice of Proposed Rulemaking (ANPR) for Chlorofluorocarbon Propellants in Self-Pressurized Containers; Determinations That Uses Are No Longer Essential; Request for Comments
(March 6, 1997)Advance Notice of Proposed Rulemaking (ANPR) for Chlorofluorocarbon Propellants in Self-Pressurized Containers; Determinations That Uses Are No Longer Essential; Request for Comments [PDF] Pulmonary and Allergy Drugs Advisory Committee, Nov. 22, 1999: Transcript Pulmonary-Allergy Drugs Advisory Committee, April 11, 1997: Transcript
Archival Documents
CFC-Free Medication for an Ailing Ozone Layer
This article in the May-June 1997 FDA Consumer magazine explains the relationship between CFCs, MDIs, and the environment.