The Food and Drug Administration (FDA) is announcing a public meeting to solicit comments on a proposed rule that would amend FDA's regulation on the use of ozone-depleting substances in self-pressurized containers to remove essential-use designations for certain oral pressurized metered-dose inhalers (MDIs). In the Federal Register of June 11, 2007 (72 FR 32030), the agency proposed to remove the essential use designation for MDIs containing flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil. Information from the public meeting, which is required by agency regulations, will be considered in finalizing the rulemaking.
- Meeting Notice (Federal Register) [HTML] [PDF]
- Proposed Rule [HTML] [PDF]
- Meeting Presentations
- FDA’s NPRM on Removing the Essential-use Designations of 7 Marketed “Moieties", Robert J. Meyer, M.D., CDER
- Boehringer Ingelheim Comment on the Proposed Rule, Thor Voigt, M.D., Boehringer Ingelheim
- Essential Use Designation: Breath-actuated Pirbuterol Acetate Inhalation Aerosol, Graceway Pharmaceuticals
- Statement from Abbott Laboratories, Rita Jain, M.D. Abbott Laboratories