Department of Health and Human Services, Food and Drug Administration: Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Flunisolide, etc.)
GAO-10-664R: May 3, 2010
- Full Report:
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(flunisolide, etxc.) GAO found that (1) the final rule amends FDA's regulations on the use of ozone-depleting substances (ODSs) in self-pressurized containers to remove the essential-use designations for flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil used in oral pressurized metered-dose inhalers (MDIs); and FDA complied with the applicable requirements in promulgating the rule.