The Food and Drug Administration (FDA), after consultation with the Environmental Protection Agency (EPA), is proposing to amend FDA's regulation on the use of ozone-depleting substances (ODSs) in self-pressurized containers to remove the essential-use designation for epinephrine used in oral pressurized metered-dose inhalers (MDIs). FDA has tentatively concluded that there are no substantial technical barriers to formulating epinephrine as a product that does not release ODSs, and therefore epinephrine would no longer be an essential use of ODSs. If the essential-use designation is removed, epinephrine MDIs containing an ODS could not be marketed after a suitable transition period. We will hold an open public meeting on the essential use of epinephrine on a date to be announced later.
- December 5 Meeting Notice and Extension of Comment Period (Federal Register) [HTML] [PDF]
- Proposed Rule: Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine). [HTML] [PDF]
- Meeting Transcript
- Presentation: CFC OTC Epinephrine: Non-Essential, Nancy Sander
- Docket 2007N-0262 Comments (All links below are PDF):
- Phase-out of Epinephrine CFC Inhalers