Use of ozone-depleting substances; removal of essential-use designations. Final rule.
The Food and Drug Administration (FDA) is amending its 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). Under the Clean Air Act, FDA, in consultation with the Environmental Protection Agency (EPA), is required to determine whether an FDA-regulated product that releases an ODS is an essential use of the ODS. Two albuterol MDIs that do not use an ODS have been marketed for more than 3 years. 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. Albuterol MDIs containing an ODS cannot be marketed after this date.
D000318:Adrenergic beta-Agonists / Q000145:classification; D000393:Air Pollutants / Q000009:adverse effects*; D000397:Air Pollution / Q000331:legislation & jurisprudence / Q000517:prevention & control*; D000420:Albuterol / Q000145:classification* / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy; D017402:Chlorofluorocarbons / Q000009:adverse effects*; D003365:Costs and Cost Analysis; D006801:Humans; D008484:Medicaid / Q000191:economics / Q000331:legislation & jurisprudence; D006278:Medicare / Q000191:economics / Q000331:legislation & jurisprudence; D036501:Metered Dose Inhalers / Q000009:adverse effects*; D010126:Ozone; D014481:United States; D014484:United States Environmental Protection Agency
D000318:Adrenergic beta-Agonists; D000393:Air Pollutants; D017402:Chlorofluorocarbons; D010126:Ozone; D000420:Albuterol