Type of Posting: General Announcement
Posting Date: 25-Mar-2022
In response to requests from stakeholders and as part of a continual review of USP Compendial policies, USP performed an analysis of the types of accelerated revisions routed via the errata process. It was found that a significant percentage of errata entries were not to correct actual errors but to update chemical information, such as chemical names and/or molecular weights for drug substances and impurities. These updates routinely occur to align the chemical information in USP-NF documentary standards with the information in the Global Substance Registration System (GSRS) and/or the United States Adopted Names (USAN).
USP will cease publishing updates to chemical information using the errata process and will instead publish these in the USP-NF Online as Compendial Notice updates (similar to Reference updates) with a six-month implementation period. Please note that this process will be used for updates only, and actual errors present in chemical information will continue to be corrected as errata. The last Errata entry which will still include updates to chemical information will be posted in June 2022. USP plans to implement the new process in USP 2023 Issue 2, to be posted online on February 1, 2023 and become official on August 1, 2023. USP will publish on its website a notice listing the updates, including alternative chemical names which may have been used in previous official documentary standards and in the documentation supporting Reference Standards. Updates will be made through direct publication in the USP-NF and will be clearly identified with the following revision markup, where CN denotes Compendial Notice: (CN 1-Aug-2023).
Should you have any questions or comments, please contact Elena Gonikberg, Sr. Principal Scientist (firstname.lastname@example.org).