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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.

2020-2022 Cumulative List of USP–NF Revisions (updated 30–Sep–2022)

The Cumulative List of USP–NF Revisions provides updated information on all items approved, deferred, orManage Configuration cancelled during the 2020-2025 Cycle.

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 48(5)

No new IRAs were published in PF 48(5)

IRAs published in 48(4)

  • Acetaminophen
  • Ammonium Sulfate
  • Isotretinoin Capsules
  • Ziprasidone Hydrochloride

IRAs published in 48(3)

  • Enoxaparin Sodium
  • Folic Acid Tablets
  • Levalbuterol Hydrochloride
  • Levalbuterol Inhalation Solution

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

IRAs published in 47(6)

  • Commentary (published 25–Mar–2022)
    • Carbidopa and Levodopa Tablets
    • Paclitaxel
    • Tetracycline
    • Tetracycline Hydrochloride
    • Tetracycline Hydrochloride Capsules

IRAs published in 47(5)

  • Commentary (published 28–Jan–2022)
    • Methotrexate
    • Selenomethionine
  • Deferrals:
    • Carbidopa and Levodopa Tablets
    • Loperamide Hydrochloride

IRAs published in 47(4)

  • Commentary (posted 19–Nov–2021)
    • Ipratropium Bromide Inhalation Solution
    • Orlistat
    • Orlistat Capsules
  • Deferred:
    • Tetracycline
    • Tetracycline Hydrochloride
    • Tetracycline Hydrochloride Capsules

Pharmacopeial Forum 47, Issues 1-3

Pharmacopeial Forum 46, Issues 1-6

Pharmacopeial Forum 45, Issues 1-6

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.

    Book

    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