Metered-Dose Inhalers

The production of ozone-depleting substances is being phased out world wide under the terms of an international agreement called the Montreal Protocol on Substances that Deplete the Ozone Layer (Montreal Protocol, September 16, 1987, S. Treaty Doc. No. 10, 100th Cong., 1st sess., 26 I. L. M. 1541 (1987)). Since most of the metered-dose inhalers (MDIs) available in the United States contained ozone-depleting chlorofluorocarbons (CFCs), many of these MDIs are being reformulated to no longer use CFCs. The reformulation effort is underway and several non-CFC products are currently approved and/or marketed for a range of different drugs (including non-CFC MDI versions for albuterol, beclomethasone, fluticasone, and ipratropium, as well as dry powder versions of fluticasone, formoterol, and salmeterol  Several more non-CFC products are in the latter stages of development.

Many people have expressed concern that the medicines they need to treat their asthma or chronic obstructive pulmonary disease will be removed from the market. CFC-MDIs will not be removed by action of the FDA until sufficient alternative medicines exist to serve the needs of patients and then these actions will only occur after public discussion.

FDA has developed a regulatory strategy to ensure that patients in the United States who rely on MDIs for their health and well being have continuing access to an array of safe and effective treatment options. This web page contains information about the use of ozone-depleting substances in medical products and the transition from their use.