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Metered-Dose Inhaler Information

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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 contain ozone-depleting chlorofluorocarbons (CFCs), these MDIs will eventually need to be reformulated to no longer use CFCs. The reformulation effort is underway and several non-CFC products are currently marketed. Several other non-ozone-depleting substance 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. There are no immediate plans to discontinue marketing any CFC-MDI for these indiciations. CFC-MDIs will not be removed until sufficient alternative medicines exist to serve the needs of patients.

FDA is developing a 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.


FDA/Center for Drug Evaluation and Research
Last Updated: June 21, 2004
Originator: OCD/RPS
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