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Type of Posting: Notice of Intent to Revise
Posting Date: 29-Jul-2022
Targeted Official Date: 01-Oct-2022; Revision Bulletin
Expert Committee: Small Molecules 1

In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules 1 Expert Committee intends to revise the Rifabutin monograph.

Comments with supporting data were received that indicate the acceptance criteria in the Organic Impurities test in the official monograph may not be applicable to all approved products. The Expert Committee proposes to widen the acceptance criteria for any unspecified impurity from NMT 0.15% to NMT 0.5% in the test for Organic Impurities to accommodate FDA approved specifications.
It is anticipated that the proposed revision will be published as a Revision Bulletin pursuant to the Rules and Procedures. 

Should you have any questions, please contact Claire Chisolm, Senior Scientist II (