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Current and Proposed FDA
Regulations Regarding the Use of Chlorofluorocarbons in Metered-Dose
Inhalers
FDA regulation
21 CFR 2.125 was written in 1978 to describe the criteria FDA uses to
permit the use of chlorofluorocarbons in an FDA-regulated product. It
defines essential use. Because of its obligations under the
Montreal Protocol and the
Clean Air Act, FDA significantly amended this regulation in 2002 to also
define criteria for when a previous essential use would no longer be
considered essential. Under this rule, FDA will undertake further rulemaking
with public comment for each determination that a previously determined
essential use is no longer considered to be essential.
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Date created: March 31, 2005 |
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