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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.

2020-2024 Cumulative List of USP–NF Revisions (updated 22-Nov-2024)

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.

USP-NF 2025, Issue 2

USP-NF 2025, Issue 1

USP-NF 2024, Issue 3

USP-NF 2024, Issue 2 (currently official)

USP-NF 2024, Issue 1

USP-NF 2023, Issue 3 

Previous USP-NF Issues

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USP-NF 2023

USP–NF 2022

USP–NF 2021

USP 43–NF 38

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

Interim Revision Announcements

IRAs published in 50(4)

No comments were received when the following proposals were published

  • Dimethyl Fumarate Delayed-Release Capsules
  • Protriptyline Hydrochloride

IRAs published in 50(3)

No comment were received when the following proposal was published

  • Methylprednisolone Acetate Injectable Suspension 

IRAs published in 50(2)

No comments were received when the following proposals were published

  • Gadopentetate Dimeglumine Injection

Commentary for IRAs published on September 27, 2024

  • Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets

IRAs published in 50(1)

  • Commentary (posted 28-Jun-2024)
    • Clonidine Transdermal System
    • Norgestimate

IRAs published in 49(6)

  • Commentary (posted 26-Apr-2024)
    • Acyclovir
    • Zinc Acetate
    • Zinc Chloride
    • Zinc Sulfate

IRAs published in 49(5)

  • Commentary (posted 26-Jan-2024)
    • <64> Probiotic Tests
    • Lactobacillus acidophilus
    • Ligilactobacillus salivarius
  • Commentary (posted 23-Feb-2024)
    • Sitigliptan Tablets

IRAs published in 49(4)

  • Commentary (posted 26-Jan-2024)
    • 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

IRAs published in 49(1)

No IRA proposals were published in PF 49(1)

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

Previous PF Issues

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Pharmacopeial Forum 48, Issues 1-6

Pharmacopeial Forum 47, Issues 1-6

Pharmacopeial Forum 46, Issues 1-6

Pharmacopeial Forum 45, Issues 1-6