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.

• Final Rule - Use of Ozone-Depleting Substances: Removal of Essential-Use Designations  [PDF] or [HTML] 

• March 6, 1997 Advance Notice of Proposed Rulemaking
• FDA Talk Paper regarding publication of ANPRM
• Public Meeting held in April 1997:  Transcript
• Pulmonary and Allergy Drugs Advisory Committee, June 10, 2004, meeting transcript. Topic: whether the use of chorofluorocarbons as propellants in albuterol-metered dose inhalers in no longer an essential use under the criteria as set forth in the Code of Federal Regulations 12 CFR 1.125.
• Pulmonary and Allergy Drugs Advisory Committee, Nov. 22, 1999, meeting transcript. Topic:  proposed revisions to 21 CFR 2.125

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