Department of Health and Human Services, Food and Drug Administration: Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
GAO-05-635R: May 5, 2005
- Full Report:
GAO reviewed the Department of Health and Human Services, Food and Drug Administration's (FDA) new rule on the removal of essential-use designations for the use of ozone-depleting substances. GAO found that (1) the rule amends FDA's regulation on the use of ozone-depleting substances (ODSs) in self-pressurized containers to remove the essential use designations for albuterol used in oral pressurized metered-dose inhalers (MDIs) because FDA has determined that the two non-ODS MDIs will be satisfactory alternatives to albuterol MDIs containing ODSs and is removing the essential-use designation for albuterol MDIs as of December 31, 2008; and (2) FDA complied with applicable requirements in promulgating the rule.