Recent Changes to the USP - What You Need to Know

Recommendation

5-7 November 2024
Hamburg, Germany

GMP meets Development
GMP and FDA Compliance in Pharmaceutical Development and IMP Manufacturing

The United States Pharmacopeia (USP) is currently introducing some changes to the format of the USP and to its online platforms. Amongst others USP plans to discontinue printing the USP-NF in the current format.

Changes announced by the USP

The following changes have been announced by the USP.

The USP plans to

• change the USP-NF Online from a publication-centric into a document-centric model. Therefore, it is planned to post a "Referencing Guideline" to help users with their internal documentation. 
• still publish the USP-NF standards on a set schedule. However, due to the document-centric platform the official date references are affected:
  - The general publication reference (e.g. USP41-NF36 1S) will no longer be an indication of an official period.
  - Each individual document within the new online publication will have its own official date reference, which is linked to a unique permanent documentary identifier (Unique DocIDs). The Unique DocIDs will only change when there is a revision to a document and do not change with each publication. 
• remove the publication name from the document view of a documentary standard from the History Tab. The "Switch Version" drop-down menu will also be removed.
• discontinue printing the USP-NF. The USP 43-NF 38 edition will be the last printed edition available! USP published an updated Compendial Notice that provides a timeline for this change.

Pharmacopeial Forum

• The Pharmacopeial Forum (PF) has already moved to a new online platform (starting with PF 45(1) in January 2019).
• The legacy PF Online platform will continue to be available for access to the old issues of PF. 
• New PF content will only be provided on the new PF Online platform.
• Submitting comments to recent drafts is only possible via the new platform.

Access to Pharmacopeial Forum (PF) online is free of charge. More information about the recent changes to USP can be found  in Frequently Asked Questions (FAQs) on the USP website.