Type of Posting: Notice of Intent to Revise
Posting Date: 01–Mar–2011
Expert Committee: Monographs—Excipients
In accordance with section 7.05(c) of the 2010–2015 Rules and Procedures of the Council of Experts, this is to provide notice that the USP Monographs—Excipients Expert Committee intends to revise the labeling section of the Ethylcellulose monograph to include a requirement to label the name and quantity of any added antioxidant. The exact language of the statement will need to be approved by the Pharmacopeial Discussion Group through the PDG Harmonization process.
It is anticipated that the proposed revision will be published on the Pharmacopeial Harmonization web page as a Stage 6 revision at a date yet to be determined, pursuant to section 7.02 of the Rules and Procedures.
Should you have questions, please contact Kevin Moore, Senior Scientific Liaison to the Expert Committee (301-816-8369 or ktm@usp.org).