1. Why did USP extend the implementation dates for USP 43–NF 38 and First Supplement to USP 43–NF 38 and FCC?
- In response to the COVID-19 pandemic, the Council of Experts voted in late March to extend the implementation dates for USP–NF and FCC in efforts to provide stakeholders flexibility to be in compliance with upcoming revisions.
2. When will I see the online platform reflect the extended implementation dates?
- USP is working to update the extended dates in all three platforms: USP–NF, FCC, and PF
- The official date of November 1, 2020 is currently reflected in USP–NF.
- You can expect for the FCC, Twelfth Edition effective date to be updated to December 1, 2020 (6-month extension) within the online platform by June 1, 2020.
- You can expect for the PF 46(2) comment deadline to be updated to July 31, 2020 (2-month extension) within the online platform by May 31, 2020.
3. What if there are documents with revisions for both USP 43–NF 38 and First Supplement to USP 43–NF 38?
- Below are four (4) documents that contain both USP 43–NF 38 and First Supplement to USP 43–NF 38 revisions. As a result, the First Supplement to USP 43–NF 38 will reflect the November 1, 2020 version. Please view the First Supplement to USP 43–NF 38 (with revision tagging displayed) and USP 43–NF 38 (revision tagging not displayed in this version). To view the revisions published in USP 43–NF 38 with highlighting and tagging, please access the "Never Official" version of this document.
- An explanatory pop-up will appear on the USP 43–NF 38 and First Supplement to USP 43–NF 38 versions of these files.
- Dobutamine Hydrochloride (USP Monograph)
- Excipients (NF Monographs)
- Description and Solubility (Reference Tables)
- Container Specifications (Reference Tables)
4. Are there any documents and revisions that will not be affected by the extended implementation dates?
- Compendial Notice updates to documents marked as (CN 1-May-2020) and (1-Aug-2020) will retain their original official dates. This includes references listed in <197> Monographs Affected by Revision to <197> Spectroscopic Identification Tests.
- Errata are not affected by the extended implementation dates and should be considered official on the date that is displayed in the revision tag. In the event that a document contains both errata and a revision from USP 43 or the First Supplement to USP 43, the official date that displays on the document will be that of the compendial revisions: November 1, 2020.
5. Are there any revision proposals in PF 46(2) that will retain the original comment deadline of May 31, 2020 and will not be affected by the extended comment period?
- Yes, Proposed Interim Revision Announcements (Proposed IRAs) published in PF 46(2) will retain the original comment deadline of May 31, 2020.
6. Will the revision tagging within the document also reflect the November 1, 2020 date?
- No, the revision tagging found within the document will not reflect the November 1, 2020 date.
You will see the November 1, 2020 official date in three places:
- On the banner at the top of a document
- On the banner under the “History” tab
- On the header of a print-out
Updated May 1, 2020