Type of Posting: Intent to Revise
Posting Date: 27–Feb–2015; updated 28–Aug–2015*
Targeted Official Date: 01–Dec–2015
Archive Date: 24–Jun–2016
Expert Committee: Monographs—Botanical Dietary Supplements and Herbal Medicines
In accordance with section 7.05 (c) of the Rules and Procedures of the Council of Experts, this is to provide notice that the Botanical Dietary Supplements and Herbal Medicines Expert Committee intends to revise the Powdered Digitalis monograph to replace Identification B. Procedure by Thin-Layer Chromatography with a new HPLC procedure that does not require USP Gitoxin RS. USP will be unable to supply USP Gitoxin RS due to the discontinuation of supply.
This proposed revision, among others, was 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. Based on comments received during the comment period, the Expert Committee decided to cancel this IRA and will propose more extensive revisions in a future issue of Pharmacopeial Forum. To address the discontinuation of the USP Gitoxin RS supply in the interim, it is anticipated that a Revision Bulletin to remove the reference to USP Gitoxin RS will be posted to the USP Website on November 20, 2015 and become official December 1, 2015.
Should you have any questions, please contact Nam-Cheol Kim, Scientific Liaison, Dietary Supplements and Herbal Medicines (301–230-7428 or firstname.lastname@example.org).
*The Notice of Intent to Revise was updated on August 28, 2015 to indicate that the proposed IRA for this revision was cancelled based and provide an update on the new revision plan for this monograph.