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Type of Posting: Notice of Intent to Revise
Posting Date: 30–Jul–2021
Targeted Official Date: 01–Nov–2021; Revision Bulletin
Expert Committee: Small Molecules 4

In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules 4 Expert Committees intends to revise the Rotigotine monograph.

Comments were received indicating that references to USP Rotigotine Hydrochloride RS were missing in the version of the monograph published in USP 43-NF 38, which became official on May 1, 2020. The Expert Committee proposes to revise the Rotigotine monograph to reinstate the references to USP Rotigotine Hydrochloride RS in the Assay, Organic Impurities, and USP Reference Standards <11> sections of the monograph. 

It is anticipated that the proposed revisions will be published as a Revision Bulletin on October 29, 2021 with an official date of November 1, 2021 pursuant to the Rules and Procedures.

Should you have any questions, please contact Claire Chisolm, Senior Scientist II (