| Use of ozone-depleting substances; removal of essential-use designation (flunisolide, etc.). Final rule. | |
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MedLine Citation:
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PMID: 20391646 Owner: HSR Status: MEDLINE |
Abstract/OtherAbstract:
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The Food and Drug Administration (FDA), after consultation with the Environmental Protection Agency (EPA), is amending FDA's regulation 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). The Clean Air Act requires FDA, in consultation with the EPA, to determine whether an FDA-regulated product that releases an ODS is an essential use of the ODS. FDA has concluded that there are no substantial technical barriers to formulating flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil as products that do not release ODSs, and therefore they will no longer be essential uses of ODSs as of the effective dates of this rule. MDIs for these active moieties containing an ODS may not be marketed after the relevant effective 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: 75 ISSN: 0097-6326 ISO Abbreviation: Fed Regist Publication Date: 2010 Apr |
Date Detail:
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Created Date: 2010-04-14 Completed Date: 2010-04-19 Revised Date: - |
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: 19213-41 Citation Subset: T |
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| MeSH Terms | |
Descriptor/Qualifier:
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Air Pollutants
/
adverse effects,
classification* Air Pollution / prevention & control* Albuterol / administration & dosage, therapeutic use Anti-Asthmatic Agents / administration & dosage, classification*, therapeutic use Asthma / drug therapy Atmosphere Bronchodilator Agents / administration & dosage, classification*, therapeutic use Chemistry, Pharmaceutical Chlorofluorocarbons / administration & dosage, adverse effects*, classification, therapeutic use Drug Costs Drug Therapy, Combination Fluocinolone Acetonide / administration & dosage, analogs & derivatives, therapeutic use Humans Ipratropium / administration & dosage, therapeutic use Nebulizers and Vaporizers / classification* Orciprenaline / administration & dosage, therapeutic use Ozone Pulmonary Disease, Chronic Obstructive / drug therapy Triamcinolone / administration & dosage, therapeutic use United States |
| Chemical | |
Reg. No./Substance:
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0/Air Pollutants; 0/Anti-Asthmatic Agents; 0/Bronchodilator Agents; 0/Chlorofluorocarbons; 10028-15-6/Ozone; 124-94-7/Triamcinolone; 18559-94-9/Albuterol; 586-06-1/Orciprenaline; 60205-81-4/Ipratropium; 67-73-2/Fluocinolone Acetonide |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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