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.

USP-NF 2025, Issue 1

• Deferrals (posted 23-Jul-2024)
• Cancellations (posted 23-Jul-2024)
• Revisions (posted 23-Jul-2024)

USP-NF 2024, Issue 3

• Deferrals (posted 26-Apr-2024)
• Cancellations (posted 26-Apr-2024)
• Revisions (posted 26-Apr-2024)
• Commentary (posted 03-Jun-2024)

USP-NF 2024, Issue 2 (currently official)

• Deferrals (posted 27-Dec-2023)
• Cancellations (posted 27-Dec-2023)
• Revisions (posted 27-Dec-2023)
• Commentary (posted 01-Feb-2024)

USP-NF 2024, Issue 1

• Deferrals (posted 29-Sep-2023)
• Cancellations (posted 29-Sep-2023)
• Revisions (posted 29-Sep-2023)
• Commentary (posted 01-Nov-2023; updated 26-Dec-2023)
• Monographs appearing in redesign format (posted 27-Dec-2023)

USP-NF 2023, Issue 3 

• Deferrals (posted 28-Apr-2023)
• Cancellations (posted 28-Apr-2023)
• Revisions (posted 28-Apr-2023)
• Commentary (posted 01-Jun-2023)

Previous USP-NF Issues

Interim Revision Announcements

IRAs published in 50(4)

• Dimethyl Fumarate Delayed-Release Capsules
• Protriptyline Hydrochloride

IRAs published in 50 (3)

• Methylprednisolone Acetate Injectable Suspension 

IRAs published in 50(2)

No comments were received when the following proposals were published

• Gadopentetate Dimeglumine Injection

The following proposal have comments under consideration

• 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