| Use of ozone-depleting substances; removal of essential-use designations. Final rule. | |
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MedLine Citation:
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PMID: 15806739 Owner: HSR Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Federal register Volume: 70 ISSN: 0097-6326 ISO Abbreviation: Fed Regist Publication Date: 2005 Apr |
Date Detail:
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Created Date: 2005-04-04 Completed Date: 2005-04-15 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 7808722 Medline TA: Fed Regist Country: United States |
Other Details:
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Languages: eng Pagination: 17167-92 Citation Subset: T |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adrenergic beta-Agonists
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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:
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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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