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Metered-Dose Inhalers (MDIs)
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.
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Date created: March 31, 2005; updated May 30, 2008 |
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