Type of Posting Notice of Intent to Revise
Posting Date 23–Feb–2018
Targeted Official Date To be determined, In-Process Revision
Expert Committee Biologics Monographs 4
In accordance with section 7.04 (c) of the 2015–2020 Rules and Procedures of the Council of Experts, this is to provide notice that the USP Biologics Monographs 4 Expert Committee intends to revise the Cloxacillin Sodium Intramammary Infusion monograph.
The Expert Committee proposes to revise the monograph’s Assay test from a microbiological-based test to a chromatographic-based to align with the drug substance and related drug products. As described in the USP Cloxacillin Sodium RS Certificate, the RS is assigned a value using a mass balance approach. In addition, the title of the monograph may change to align with current nomenclature practices described in USP Chapter <1121> Nomenclature.
It is anticipated that the proposed revision will be published in the future once the laboratory work is complete as an In-process Revision in the Pharmacopeial Forum pursuant to section 7.02 of the Rules and Procedures.
Should you have any questions, please contact Julie Zhang, Scientific Liaison to the USP Biologics Monographs 4 Expert Committee (301–816–8350 or julie.zhang@usp.org).