Type of Posting: Intent to Revise
Posting Date: 27–Feb–2015
Targeted Official Date: 01–Nov–2015
Expert Committee: Monographs—Dietary Supplements and Herbal Medicines
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 Dietary Supplements and Herbal Medicines Expert Committee intends to revise the Digoxin monograph to replace Procedure 1: Related glycosides with a new quantitative HPLC procedure that does not require USP Gitoxin RS. USP will be unable to supply USP Gitoxin RS due to the discontinuation of supply.
It is anticipated that the proposed revision will be published as an Interim Revision Announcement (IRA) in Pharmacopeial Forum 41(3) [May–Jun. 2015] pursuant to section 7.02 of the Rules and Procedures. The comment period for this revision ends on July, 31, 2015. In the absence of any adverse comments the proposed IRA will become official on November 1, 2015.
Should you have any questions, please contact Nam-Cheol Kim, Scientific Liaison, to the Dietary Supplements and Herbal Medicines (301-230-7428 or nck@usp.org).