Type of Posting: Intent to Revise
Posting Date: 27–Jun–2014
Targeted Official Date: 01–Mar–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 Monographs—Dietary Supplements and Herbal Medicines Expert Committee intends to revise the Ganoderma Lucidum Fruiting Body and Ganoderma Lucidum Fruiting Body Powder monographs.
Comments with supporting data were received that indicate that the proposed specifications related to the retardation factor in the Identification A by HPTLC are overly restrictive without adding substantive quality to either monograph. Furthermore, color interpretation of one of the HPTLC bands for ergosterol was shown to be subjective. Accordingly, the Expert Committee proposes to revise Ganoderma Lucidum Fruiting Body and Ganoderma Lucidum Fruiting Body Powder monographs to remove the specifications related to retardation factors in the Identification A by HPTLC procedure, and to delete the color description of the ergosterol band.
It is anticipated that proposed revisions of the Ganoderma Lucidum Fruiting Body and Fruiting Body Powder monographs will be published as Interim Revision Announcements (IRA) in Pharmacopeial Forum 40(5) [Sep.–Oct. 2014] pursuant to section 7.02 of the Rules and Procedures. The comment period for these revisions ends on November, 30, 2014. In the absence of any adverse comments the proposed IRA will become official on March 1, 2015.
Because these monographs, including the Identification A by HPTLC sections, are scheduled to become official on November 1, 2014 in Supplement 2 to USP 37–NF 32, the Monographs—Dietary Supplements and Herbal Medicines Expert Committee intends to provide an interim solution by postponing the Identification A by HPTLC section in the Ganoderma Lucidum Fruiting Body and Ganoderma Lucidum Fruiting Body Powder monographs, until it has been revised via an IRA. It is anticipated that respective Revision Bulletins postponing the Identification A by HPTLC section of these monographs will be posted on USP’s website on July 25, 2014 and become official August 1, 2014.
Should you have any questions, please contact Anton Bzhelyansky, Scientific Liaison to the Dietary Supplements and Herbal Medicines Expert Committee (301-816-6303 or anb@usp.org).