Type of Posting: Notice of Intent to Revise
Posting Date: 30–Oct–2015; updated 29–Apr–2016*
Targeted Official Date: 01–Jan–2017; Interim Revision Announcement
Expert Committee: Chemical Medicines Monographs 3
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 Monographs—Chemical Medicines 3 Expert Committee intends to revise the Eprinomectin monograph.
The current procedure for Limit of Residual Solvents is cumbersome and includes acceptance criteria that are not consistent with currently approved limits. The Expert Committee proposes to revise the Eprinomectin monograph to omit the Limit of Residual Solvents test from the monograph and instead use the concepts and acceptance criteria outlined in the General Notices and General Chapter <467> Residual Solvents for the control of residual solvents related to drug products containing Eprinomectin drug substance.
Additionally, USP intends to streamline and update other sections of the monograph, and make it consistent with current USP editorial style.
It is anticipated that the proposed revisions will be published as Interim Revision Announcements (IRA) in Pharmacopeial Forum 42(4) [Jul.–Aug. 2016] pursuant to section 7.02 of the Rules and Procedures. The comment period for this revision ends on September 30, 2016. In the absence of any adverse comments the proposed IRAs will become official on January 1, 2017.
Should you have any questions, please contact Morgan Puderbaugh, Scientific Liaison to the Monographs—Chemical Medicines 3 Expert Committee (301-816-8373 or firstname.lastname@example.org).
*The notice was updated to specify that the proposed version will be published as an IRA in PF 42(4) [Jul.–Aug. 2016] with a targeted official date of January 1, 2016.