Skip to main content

FAQs: Extended Date Implementation

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. 

    1. Dobutamine Hydrochloride (USP Monograph)
    2. Excipients (NF Monographs)
    3. Description and Solubility (Reference Tables)
    4. 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.
    • Please note that in case a Currently Official version of a document still references the old title or subtitles to <197>, by clicking on the <197> hyperlink, you will be directed to the Currently Official version of the general chapter which reflects the new chapter title and sub-titles as follows:
      • use of the chapter title Spectrophotometric Identification Tests (now Spectroscopic Identification Tests) permitted until May 1, 2020. 
      • use of the section title Infrared Absorption (now Infrared Spectroscopy) permitted until May 1, 2020.
      • use of the section title Ultraviolet Absorption (now Ultraviolet-Visible Spectroscopy) permitted until May 1, 2020.
  • 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 USP 43 or First Supplement to USP 43 revisions: November 1, 2020.
  • Harmonized text also is not affected by the extended date since USP treats Harmonization documents as Accelerated Revisions. Harmonization documents, when available, publish into the USP-NF Online on a monthly basis and then become official on their own schedule. Please refer to a specific documentary standard for the official date. 
    • Please note that the Gelatin monograph was not impacted by the extended date and became official on May 1, 2020. 
    • Please note that the <701> general chapter was not impacted by the extended date and became official on May 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:

  1. On the banner at the top of a document
  2. On the banner under the “History” tab
  3. On the header of a print-out

7.    Are there any other documents that have been impacted by the extended date?

  • The general chapter <1046> will undergo a new title change starting on November 1, 2020. However, there are some documents that either refer to the currently official or the to be official chapter title. For these instances, there are two options. Either refer to the new, to be official, title “〈1046〉 Cell-Based Advanced Therapies and Tissue-Based Products” for early adoption or use the currently official title, “〈1046〉 Cellular and Tissue-Based Products”.

 


Updated July 17, 2020