Type of Posting: Publication Announcement
Posting Date: 30–Jan–2019
In response to the government shutdown, lasting 35 days (December 22, 2018 to January 25, 2019), USP will be extending the comment deadline for both PF 44(6) and PF 45(1) by 60 days.
Full engagement and participation of all stakeholders is critical to the functioning of the compendial standards development process; our Federal regulatory and public health partners are an integral part of this process. The Federal government’s ability to participate in the standards-setting process was strictly limited during the partial lapse in government funding. For this reason, USP is committed to providing assurance that our public health partners will be given sufficient time to review and provide feedback on PF proposals. Please see the table below for information on the revised PF comment schedule.
|Pharmacopeial Forum||Current Comment Deadline||New Comment Deadline|
|PF 44(6) [Nov.–Dec. 2019]||January 31, 2019||March 31, 2019*|
|PF 45(1) [Jan.–Feb. 2019]||March 31, 2019||May 31, 2019*|
|PF 45(2) [Mar.–Apr. 2019]||May 31, 2019||May 31, 2019 (unchanged)|
In addition to extending the PF comment deadlines, USP will work with the Federal government to determine if additional considerations need to be made to ensure they are aware of activities that occurred during the government shut down. We will continue to monitor the situation and provide an update as needed.
Should you have any questions, please contact Sohail Mosaddegh, US Regulatory Affairs Manager (301-692-3395 or firstname.lastname@example.org).