Document Detail


Use of ozone-depleting substances; removal of essential-use designations. Final rule.
MedLine Citation:
PMID:  15806739     Owner:  HSR     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Federal register     Volume:  70     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  2005 Apr 
Date Detail:
Created Date:  2005-04-04     Completed Date:  2005-04-15     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  United States    
Other Details:
Languages:  eng     Pagination:  17167-92     Citation Subset:  T    
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MeSH Terms
Descriptor/Qualifier:
Adrenergic beta-Agonists / classification
Air Pollutants / adverse effects*
Air Pollution / legislation & jurisprudence,  prevention & control*
Albuterol / classification*,  therapeutic use
Asthma / drug therapy
Chlorofluorocarbons / adverse effects*
Costs and Cost Analysis
Humans
Medicaid / economics,  legislation & jurisprudence
Medicare / economics,  legislation & jurisprudence
Metered Dose Inhalers / adverse effects*
Ozone*
United States
United States Environmental Protection Agency
Chemical
Reg. No./Substance:
0/Adrenergic beta-Agonists; 0/Air Pollutants; 0/Chlorofluorocarbons; 10028-15-6/Ozone; 18559-94-9/Albuterol

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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