Type of Posting: Notice of Intent to Revise
Posting Date: 24–Apr–2020
Targeted Official Date: 01–Nov–2020, Revision Bulletin
Expert Committee: Chemical Medicines Monographs 3 Expert Committee
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 Chemical Medicines Monographs 3 Expert Committee intends to revise the Loperamide Hydrochloride monograph to address the inadvertent omission of text that was published in Pharmacopeial Forum (PF) and approved by the Expert Committee.
Specifically, a revision for Impurities, Organic Impurities was proposed in PF 43(4), and ultimately was approved by the Expert Committee. However, Total Impurities was inadvertently omitted from Impurities, Organic Impurities Table 2 when the monograph was published as final approved text in the USP-NF. The Chemical Medicines Monographs 3 Expert Committee proposes to address this issue by publishing a Revision Bulletin to include Total Impurities in Impurities, Organic Impurities Table 2.
Although USP is publishing this corrective Revision Bulletin on May 29, 2020, the official date for the revised Loperamide Hydrochloride monograph will be November 1, 2020. This extended implementation time frame is being provided to align the official dates of revisions to this monograph with USP’s extension of certain implementation periods due to the COVID-19 pandemic. See this Notice for details.
Should you have any questions, please contact Andrea F. Carney, Scientific Liaison to the Chemical Medicines Monographs 3 Expert Committee (301–816–8155 or firstname.lastname@example.org).