USP–NF's Continuous Revision Process and Superseded Text
The United States Pharmacopeia–National Formulary (USP–NF) is continuously revised. Revisions are presented annually in the USP–NF, in twice-yearly Supplements, and as Accelerated Revisions on the USP website. USP uses its Accelerated Revision processes to expedite revisions to the USP–NF. Accelerated Revisions include Revision Bulletins, Interim Revision Announcements (IRAs), and Errata.
Accelerated Revisions: Revision Bulletins, IRAs, & Errata
- Revision Bulletins, USP's most expedited revisions, supersede standards published in the USP–NF and its Supplements (print and online versions). A Revision Bulletin posted on the USP website indicates its official date and the date that it will be incorporated into an official publication. View current Revision Bulletins.
- IRAs are proposed in PF for a 90-day public comment period. Once comments (if any) are reviewed and the IRA is approved by the appropriate Expert Committee, final IRAs are posted on the USP website. Like Revision Bulletins, IRAs supersede standards published in the print and online USP–NF and its Supplements. IRAs are incorporated into the next available official publication. View current IRAs.
- Errata are considered to be text erroneously published in the USP–NF or its Supplements that does not accurately reflect the intended requirements as approved by the Council of Experts. Errata are posted on the Web site and are official the first day of the following month. Errata are incorporated into the next available official publication. View current Errata.
Once published in the print and online publications, Revision Bulletins and IRAs are official as of the date indicated on the website and are not subject to the general six-month delayed official date for the particular publication.
Learn more by visiting the Accelerated Revision History and the USP Guideline on Use of Accelerated Processes for Revisions to the USP–NF. To receive periodic email updates when USP posts New Official Text, sign up for the free Compendial Updates service.
Harmonization Stage 6
Harmonization Stage 6 includes monographs or general chapters that have completed stages 1-6 of the pharmacopeial harmonization process resulting in approved USP–NF text. Stage 6 adopted text is published so that USP–NF users may become aware of its availability as a pharmacopeial standard and its targeted official date. View current Notices of Stage 6 Harmonization.
USP Reference Standards Information
In addition, USP now posts lists of "New USP Reference Standards" and "Unavailable First-time Official USP Reference Standards" below. This information previously appeared in the IRA section of Pharmacopeial Forum (PF).
- New USP Reference Standards (RS)—updated July 25, 2014
The following USP RS, which were not available when the associated monograph was made official, have since become available. The respective official date of each USP–NF standard, test, or assay requiring the use of the following USP RS is indicated in parentheses after the name of the RS.
- Fondaparinux Sodium SS Mixture A (April 2014)
- Fondaparinux Sodium SS Mixture B (April 2014)
- Fondaparinux Sodium Identification (April 2014)
- Fondaparinux Sodium for Assay (April 2014)
- Dalteparin Sodium (April 2014)
- Insulin Glargine (June 2014)
- Insulin Glargine for Peak Identification (June 2014)
- Fetal Bovine Serum (June 2014)
- Pegfilgrastim for Bioassay (June 2014)
- The official dates of any USP–NF standards, tests, or assays requiring the use of the following new USP RS are postponed until further notice pending availability of the respective RS. Please refer to the current USP Daily Catalog for a more up-to-date availability list.
- USP Alteplase RS
- USP Antithrombin III Human RS
- USP Aprotinin RS
- USP Aprotinin System Suitability RS
- USP rProtein A, B4 C-Cys RS
- USP Sargramostim RS
Sign up for the free Reference Standards Release Notification Program to be notified when a new never-before-released Reference Standard becomes available.