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Fluticasone Propionate Nasal Spray

Type of Posting: Revision Bulletin

Posting Date: 28–Jan–2011

Official Date: 01–Feb–2011

Expert Committee: Monographs—Small Molecules 4

Reason for Revision: Compliance

In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 4 Expert Committee has revised the Fluticasone Propionate Nasal Spray monograph. The purpose for the revision is to accommodate the sponsor's FDA-approved acceptance criteria for the Content of Benzalkonium Chloride as follows:

  • Widen the range from 160 μg/g–210 μg/g to 140 μg/g–220 μg/g

The Fluticasone Propionate Nasal Spray Revision Bulletin supersedes the currently official Fluticasone Propionate Nasal Spray monograph. The Revision Bulletin will be incorporated in Second Supplement to USP 34–NF 29.

Should you have any questions, please contact Ravi Ravichandran (301-816-8330 or rr@usp.org).