Type of Posting: Publication Announcement
Posting Date: 15–Jun–2020
The COVID-19 pandemic has placed unprecedented burdens on the public health infrastructure, including the drug supply chain. To support affected stakeholders while continuing to promote quality and public health during this difficult period, USP announced the extension of specific implementation time frames and public comment periods in a Compendial Notice posted on March 27, 2020 . This announcement communicates one further extension; specifically, USP will be extending the comment deadline for Pharmacopeial Forum (PF) 46(3) [May−Jun. 2020] one month (from July 31, 2020 to August 31, 2020.)
The extended public comments deadline for proposals presented in PF 46(3) does not apply to Proposed Interim Revision Announcements (IRAs). These proposals (listed below) retain the original public comment deadline of July 31, 2020:
- General Notices and Requirements
- Cetyl Alcohol
- Stearyl Alcohol
- Telmisartan and Amlodipine Tablets
Please see the table below for information on the revised PF comment schedule.
|Pharmacopeial Forum||Current Comment Deadline||New Comment Deadline|
|PF 46(3) [May–Jun. 2020]||July 31, 2020||August 31, 2020
Proposed IRAs: July 31, 2020 (unchanged)
|PF 46(4) [Jul.–Aug. 2020]||September 30, 2020||September 30, 2020 (unchanged)|
We recognize that our stakeholders have made significant strides in adjusting their operations to adapt to the ongoing pandemic conditions. USP is hopeful that such implemented adaptations and observed improvements in global conditions will permit a return to normal scheduled implementation and comment periods going forward.
Should you have any questions, please contact Jessica Simpson, Compendial Operations (301-816-8231 or firstname.lastname@example.org.