Public Meeting on Essential Uses of Ozone Depleting Substances, December 5, 2007

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]
• Agenda
• Meeting Transcript
• Presentation: CFC OTC Epinephrine: Non-Essential, Nancy Sander
  
• Docket 2007N-0262 Comments (All links below are PDF):

  Electronic Comment 1 Electronic Comment 2 Electronic Comment 3 Electronic Comment 4 Electronic Comment 5 Electronic Comment 6 Electronic Comment 7 Electronic Comment 8 Electronic Comment 9 Electronic Comment 10 Electronic Comment 11 Electronic Comment 12

  Written Comment 1 Written Comment 2 Written Comment 3 Written Comment 5 Written Comment 6 Written Comment 7 Written Comment 8

• Phase-out of Epinephrine CFC Inhalers