Type of Posting: Notice of Intent to Revise
Posting Date: 27-Mar-2020
Targeted Official Date: 01-Aug-2020 for Revision Bulletin; To be determined for In-Process Revision
Expert Committee: Chemical Medicines Monographs 2
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 Chemical Medicines Monographs 2 Expert Committee intends to revise the Clonidine Transdermal System monograph.
Based on the supporting data received, the Expert Committee proposes to revise the Clonidine Transdermal System monograph to incorporate additional FDA approved specifications via Revision Bulletin and In Process Revision.
It is anticipated that the proposed revision for adding the Drug Release Test 4 will be published as a Revision Bulletin with a targeted official date on August 1, 2020 and the revision of Identification, Assay and Organic Impurities tests will be published as an In-Process Revision in the Pharmacopeial Forum (PF) pursuant to section 7.02 of the Rules and Procedures.
Should you have any questions, please contact Yanyin Yang, Associate Scientific Liaison to the USP Chemical Medicines Monographs 2 Expert Committee (301–692–3623 or Yanyin.Yang@usp.org).