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HHS/FDA RIN: 0910-AF93 Publication ID: Spring 2008 
Title: Use of Ozone-Depleting Substances; Removal of Essential Use Designations [Flunisolide, Triamcinolone, Metaproterenol, Pirbuterol, Albuterol and Ipratropium in Combination, Cromolyn, and Nedocromil] 
Abstract: Medical products using chlorofluorocarbons (CFCs) and other ozone-depleting substances may only be legally marketed if they are listed in 21 CFR part 2.125 as “essential uses.” This final rule would remove the essential use designations after a specified date for metered-dose inhalers (MDIs) containing flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil. Under the provisions of this final rule, these MDIs would have to be removed from the market. This final rule is consistent with obligations under the Clean Air Act and the Montreal Protocol on Substances That Deplete the Ozone Layer. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 2.125 (Revision); 40 CFR 82.4; 40 CFR 82.64; 40 CFR 82.66 
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 335; 21 USC 342; 21 USC 346a; 21 USC 348; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 360b; 21 USC 361; 21 USC 362; 21 USC 371; 21 USC 372; 21 USC 374; 42 USC 7671 et seq 
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  06/11/2007  72 FR 32030 
NPRM Comment Period End  09/10/2007   
Final Rule  10/00/2008   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Martha Nguyen
Senior Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, WO 51, Room 6250, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
Phone:301 796-3601
Fax:301 847-8440
Email: martha.nguyen@fda.hhs.gov

 
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