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Monographs Affected by Revision to <561> Articles of Botanical Origin

Type of Posting: Notice of Intent to Revise
Posting Date: 04–Oct–2019
Targeted Official Date: 01–May–2020
Expert Committee: Various

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 USP and its Expert Committees, as applicable, intend to revise multiple monographs in response to a revision of General Chapter <561> Articles of Botanical Origin.

General Chapter <561> Articles of Botanical Origin was revised earlier to limit Pesticides Residues in monographs for botanical extracts. The requirements for Pesticides Residues for botanical extracts were later introduced in Chapter <565> Botanical Extracts in Pharmacopeial Forum 40(5). On October 26, 2018, USP posted a Compendial Notice alerting customers to proposed cross reference changes from <561> to <565> in several monographs. Please see this Notice for further information.

These references will be updated in USP 43–NF 38. All modifications will become official on May 1, 2020. A list of the monographs that will be modified can be found here .

Please also see the Compendial Notice: New Revision Markup for Reference Changes in USP–NF for details on the revision markup used to identify the reference updates.

Interested stakeholders are encouraged to alert USP staff to any impact they may recognize related to the update of those monographs.

Should you have any questions or comments, please contact Maria Monagas, Scientific Liaison (301) 230-7422 or, or the affected monograph’s liaisons.