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General Chapter <561> Articles of Botanical Origin

Type of Posting: Notice of Intent to Revise

Posting Date: 30–June–2017

Targeted Official Date: 01–May–2019

Expert Committee: Botanical Dietary Supplements and Herbal Medicines

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 Botanical Dietary Supplements and Herbal Medicines Expert Committee intends to revise the General Chapter <561> Articles of Botanical Origin.

Considering the very low use of USP Aflatoxins RS and the common practices in the industry, the Expert Committee proposes to revise the Aflatoxins section of General Chapter <561> Articles of Botanical Origin to replace the use of USP Aflatoxins RS by an Aflatoxins Test Solution. This solution can be prepared from pure aflatoxins available from commercial sources or obtained already prepared from available commercial sources.

It is anticipated that the proposed revision will be published as In Process Revision in Pharmacopeial Forum 44(1) [Jan.–Feb. 2018] pursuant to section 7.02 of the Rules and Procedures. The comment period for this revision ends on March 31, 2018. In the absence of any adverse comments, the proposed revision will become official on May 1, 2019.

Should you have any questions, please contact Maria Monagas, Scientific Liaison to the Botanical Dietary Supplements Expert Committee (301–816–7422 or mjm@usp.org).