Department of Health and Human Services, Food and Drug Administration: Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)

GAO-09-237R December 10, 2008
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Summary

GAO reviewed the Department of Health and Human Services, Food and Drug Administration's (FDA) new rule on the use of ozone-depleting substances and the removal of essential use designation (epinephrine). GAO found that (1) the final rule removes epinephrine used in oral pressurized metered-dose inhalers from FDA's list of essential-use ozone-depleting substances that have been exempt from the Clean Air Act restrictions on their use; and (2) FDA complied with applicable requirements in promulgating the rule.