Type of Posting: General Announcement
Posting Date: 19–May–2020
This is to provide notice that the Chemical Medicines 1 Expert Committee (CHM1 EC) will be publishing a major revision to the monograph for Hydroxychloroquine Sulfate on June 1, 2020. The revised monograph including a specific HPLC assay and a new test for Organic Impurities appeared as an In-Process Revision in Pharmacopeial Forum 44(2) [Mar-Apr 2018] and was deferred based on comments received. In response to the COVID-19 pandemic and in collaboration with the U.S. Food and Drug Administration and stakeholders, the Expert Committee worked to finalize the monograph for publication in the USP-NF. The updated monograph will be published on June 1, 2020 in USP 43–NF 38, Second Supplement.
To provide additional time for the manufacturers to adopt the new requirements, the CHM1 EC has approved the monograph revision with a 12-month implementation period. The monograph revision will become official on June 1, 2021. Per the USP–NF General Notices and Requirements, Section 3.10 Applicability of Standards, early adoption of revised standards in advance of the official date is allowed by USP, unless specified otherwise at the time of publication.
The summary of comments received and the Expert Committee responses will be included in the USP 43-NF 38, Second Supplement Commentary which will be posted June 1, 2020 on the Proposal Status/Commentary page on USPNF.com. Please disregard the earlier notice in the USP 43–NF 38, Second Supplement list of deferrals (posted April 24, 2020) noting that this revision had been deferred.
Should you have any questions, please contact Shankari Shivaprasad, Senior Scientific Liaison–Team Leader (301-230-7426 or firstname.lastname@example.org).