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Proposal Status/Commentary

After a standard is proposed in Pharmacopeial Forum (PF) for public comment, the assigned Expert Committee reviews the comments and determines whether to approve the standard as a Revision, defer or cancel the standard. USP posts the lists of Revisions, Deferrals, Cancellations, and Commentary for each Issue of USP–NF.

  • Revisions are items that have been proposed in PF, were approved by the assigned Expert Committee, and will appear in the noted publication. These items will have corresponding Commentary (see below).
  • Deferrals are items that have been proposed in PF but are not yet approved by an Expert Committee. Items that have been deferred can be approved and published in a subsequent Issue of USP–NF. Some deferrals are later canceled.
  • Cancellations are items that have been proposed in PF but will not move forward to ballot and subsequent publication. Canceled items may be re-proposed in a future PF.

Commentary is a summary of comments received and the assigned Expert Committee's responses. Commentary is published for Revisions only. In cases where proposals have been re-published in PF, only comments from the most recent PF publication are included in Commentary. Revisions, Deferrals, and Cancellations generally are posted prior to publication in USP–NF Online. Commentary is posted the same day the official text is published in USP–NF Online.

2020-2023 Cumulative List of USP–NF Revisions (updated 29-Nov-2023)

The Cumulative List of USP–NF Revisions provides updated information on all items approved, deferred, or cancelled during the 2020-2025 Cycle. Cumulative List from 2015-2020 cycle can be found here.

Interim Revision Announcements

As of First Supplement to USP 43–NF 38, IRAs are no longer associated with a print publication and are immediately available on USP–NF Online.

IRAs published in 49(6)

  • Norgestimate
  • Zinc Acetate
  • Zinc Chloride
  • Zinc Sulfate

IRAs published in 49(5)

  • <64> Probiotic Tests
  • Lactobacillus acidophilus
  • Ligilactobacillus salivarius
  • Sitigliptan Tablets

IRAs published in 49(4)

  • Fosfomycin Tromethamine

IRAs published in 49(3)

No IRA proposals were published in PF 49(3)

  • Commentary (posted 25-Aug-2023)
    • <660> Containers- Glass
    • <661.2> Plastic Packaging System for Pharmaceutical Use
  • Commentary (posted 29-Sep-2023)
    • Phenoxybenzamine Hydrochloride

IRAs published in 49(2)

No comments were received when the following item was published:

  • Bicalutamide Tablets

The following items were deferred:

  • <660> Containers- Glass
  • <661.2> Plastic Packaging Systems for Pharmaceutical Use
  • Acyclovir
  • Phenoxybenzamine Hydrochloride

IRAs published in 49(1)

No IRA proposals were published in PF 49(1)

  • Commentary (posted 26-May-2023)
    • Ziprasidone Hydrochloride

IRAs published in 48(6)

No comments were received when the following items were published:

  • <711> Dissolution
  • Urea C 13

IRAs published in 48(5)

No new IRAs were published in PF 48(5)

  • Commentary (posted 27-Jan-2023)
    • Isotretinoin Capsules
  • Deferred
    • Ziprasidone Hydrochloride

IRAs published in 48(4)

  • Commentary (posted 20-Dec-2022)
    • Acetaminophen
    • Enoxaparin Sodium
    • Ammonium Sulfate
  • Deferred
    • Isotretinoin Capsules
    • Ziprasidone Hydrochloride

IRAs published in 48(3)

  • Commentary (published 03-Oct-2022)
    • Folic Acid Tablets
    • Levalbuterol Hydrochloride
    • Levalbuterol Inhalation Solution
  • Deferred:
    • Enoxaparin Sodium

IRAs published in 48(2)

  • Commentary (published 09-Aug-2022)
    • <89.2> Collagenase II
    • Fluticasone Propionate Inhalation Aerosol
    • Fluticasone Propionate Inhalation Powder
    • Fluticasone Propionate and Salmeterol Inhalation Aerosol
    • Fluticasone Propionate and Salmeterol Inhalation Powder
    • Mesalamine Delayed-Release Tablets
    • Salmeterol Inhalation Powder
    • Starch TS

IRAs published in 48(1)

  • Deferrals:
    • <89.2> Collagenase II
    • Mesalamine Delayed-Release Tablets

    Pharmacopeial Forum 47, Issues 1-6

    Pharmacopeial Forum 46, Issues 1-6

    Pharmacopeial Forum 45, Issues 1-6

    USP-NF 2024, Issue 1

    USP-NF 2023, Issue 3

    USP–NF 2023, Issue 2

    USP–NF 2023, Issue 1

    USP–NF 2022, Issue 3

    USP–NF 2022, Issue 2

    USP–NF 2022, Issue 1

    USP–NF 2021, Issue 3

      USP–NF 2021, Issue 2

      USP–NF 2021, Issue 1

      USP 43–NF 38

      Supplement 2

      Supplement 1

      Due to the extended comment period for Pharmacopeial Forum 45(1), it will be included in the publication for Supplement 1 instead of that for USP–NF.


      IRAs published in 44(6)

      • There were no IRAs published for comment in 44(6)

      USP 42–NF 37

        USP 41–NF 36

          USP 40–NF 35

            USP 39–NF 34

            USP 38–NF 33

            USP 37–NF 32

            USP 36–NF 31

            USP 35–NF 30

            USP 34–NF 29

            USP 33–NF 28

            USP 32–NF 27

            USP 31–NF 26

            USP 30–NF 25