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Public Meeting Scheduled for Ozone-Depleting Substance Ban

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The FDA will hold a public meeting Dec. 19 to solicit comments on its proposed rule expanding a ban on the use of ozone-depleting substances (ODSs) in metered-dose inhalers (MDIs) to include products containing epinephrine, such as Wyeth’s Primatene Mist.

The agency recently proposed removing the essential-use designation for epinephrine MDIs, effectively banning the use of such products. A 2011 implement date is proposed.

Suggested topics for discussion at the meeting include the fact that epinephrine MDIs are the most widely used OTC treatments for asthma. Another subject up for consideration is whether production supply of albuterol hydrofluoroalkane MDIs, the primary therapeutic alternative to OTC epinephrine, will be sufficient to meet the demand created by the proposed rule.

The agency also is seeking input on what efforts are under way to develop non-ODS epinephrine inhalers and whether the availability of such inhalers should be considered when selecting an implementation date for the rule.

The meeting will be held from 9 a.m. to 3:30 p.m. in the FDA’s advisory committee conference room at 5630 Fishers Lane, Rockville, Md. Registrations for the meeting will be accepted until Nov. 23.

In addition to convening the public meeting, the FDA is extending the comment period for the proposed rule by one month, to Dec. 19. More information can be accessed at www.fda.gov/OHRMS/DOCKETS/98fr/
07n-0262-nec0001.pdf
.