FDA revises judgments made on products containing ozone-depleting substances

ROCKVILLE, Md. The Food and Drug Administration issued a final rule earlier this month that amends the agency’s regulation on the use of ozone-depleting substances in self-pressurized containers—the over-the-counter asthma symptom reliever epinephrine no longer has “essential use” designation.

“After consulting with the U.S. Environmental Protection Agency, FDA says it has determined that there are no substantial technical barriers to formulating epinephrine as a product that does not release ODSs. Therefore, the agency has concluded that epinephrine would no longer be an essential use of ODSs,” the Consumer Healthcare Products Association stated in its newsletter Wednesday.

Manufacturers have until Dec. 31, 2011 to discontinue distribution of epinephrine inhalers that emit ODSs.