Compendial Notices

USP–NF Compendial Notices are designed to inform stakeholders of the changing status of USP–NF monographs and general chapters and other USP–NF standards-setting initiatives. Compendial Notices include General Announcements, Notices of Intent to Revise, and Publications Corrections.

Notices are generally posted at the end of the month, but can be posted at any time depending upon the urgency of the notice. USP posts Compendial Notices by general chapter (numerical order), then by monograph name (alphabetical order). The "New Notices" section includes the most recently posted Compendial Notices in chronological order.

Main Topics

Select from the below links to navigate to the main topics on this page:

• New Notices
• General Announcements
• Notices of Intent to Revise
• Notices of Intent to Revise: Pending Monograph Program
• General Chapter Prospectus
• Reference Changes
• Publications Announcements
• USP–NF Redesigned Monographs
• Retired Compendial Notices

New Notices

• New Publication Announcement: USP–NF Online: Upcoming Corrections to Official Dates in History Tab and Banner (posted 15–Jan–2021)
• New Notice of Intent to Revise: Benztropine Mesylate (posted 28–Dec–2020)
• New Notice of Intent to Revise: <661.1> Plastic Materials of Construction (posted 18–Dec–2020)
• New Notice of Intent to Revise: Tetracycline, Tetracycline Hydrochloride and Tetracycline Hydrochloride Capsules (posted 18–Dec–2020)
• Updated Notice of Intent to Revise: Talc (updated 18–Dec–2020)
• New Pending Notice of Intent to Revise: Chlorpromazine Hydrochloride Oral Concentrate (posted 18–Dec–2020)
• New Pending Notice of Intent to Revise: Metolazone Tablets (posted 18–Dec–2020)
• New Pending Notice of Intent to Revise: Quetiapine Extended-Release Tablets (posted 18–Dec–2020)
• Updated General Announcement: <1085.1> Use of Recombinant Reagents in the Bacterial Endotoxins Test: Comments Received from Stakeholders (posted 18–Nov–2020; updated 11–Dec–2020)

General Announcements

General Announcements are posted on USP's website to provide USP–NF users with general information about the USP–NF, Supplements, Pharmacopeial Forum (PF), or other USP standards-setting activities.

• <1085.1> Use of Recombinant Reagents in the Bacterial Endotoxins Test: Comments Received from Stakeholders (posted 18–Nov–2020; updated 11–Dec–2020)
• Deferred Proposal: General Notices and Requirements, 5.60.40 Impurities that are Unusually Toxic and/or Mutagenic (posted 30–Sep–2020) 
• First Draft of Roadmap for Addressing Element-Specific Chapters and Tests in Excipient Monographs (posted 05–Aug–2020)
• New Inhalation Product Monographs: Proposed Approach for Performance Tests using Non-standard Apparatus (posted 28–Aug–2020; comment deadline 30–Nov–2020)
• Update: Guidance on the Use of Recombinant Reagents for Bacterial Endotoxin Test (posted 28–Aug–2020)
• Update: Reporting Thresholds in USP–NF Monographs (posted 12–Oct–2020)

Notices of Intent to Revise

USP provides Intent to Revise Announcements to notify users of official text that is under revision. Note: Intent to Revise notices for reference related changes are listed below in the Reference Changes section.

• Amantadine Hydrochloride (posted 27–May–2020)
• Aminocaproic Acid Oral Solution (posted 31–Jul–2020)
• Aprepitant Capsules, Galantamine Tablets, Praziquantel Tablets, and <1092> The Dissolution Procedure: Development and Validation (posted 28–Aug–2020)
• Benztropine Mesylate (posted 28–Dec–2020)
• Castor Oil (posted 31–Jul–2020)
• Diphenhydramine Hydrochloride Oral Powder (posted 25–Sep–2020)
• Clonidine Transdermal System (posted 27–Mar–2020)
• Gemfibrozil Tablets (posted 28–Aug–2020)
• Lactobacillus Rhamnosus (posted 20–Nov–2020)
• Monographs Affected by Revision to <601> Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders—Performance Quality Tests (posted 02–Oct–2020)
• New Notice of Intent to Revise: Monograph Affected by Revision to <1195> Significant Change Guide for Bulk Pharmaceutical Excipients (posted 02–Oct–2020)
• Monograph Affected by Revision to <1195> Significant Change Guide for Bulk Pharmaceutical Excipients (posted 02–Oct–2020)
• Monographs Affected by Revision to <1788> Methods for the Determination of Particulate Matter in Injections and Ophthalmic Solutions (posted 02–Oct–2020)
• Talc (posted 31–Jul–2020; updated 18–Dec–2020)

Notices of Intent to Revise: Pending Monograph Program

For more information please see the Pending Monograph Program webpage

• Abiraterone Acetate Tablets (posted 25–Jan–2019)
• Albendazole Tablets (posted 28–Feb–2020)
• Amlodipine and Olmesartan Medoxomil Tablets (posted 24–Apr–2020)
• Aminocaproic Acid Oral Solution (posted 31–Jan–2020)
• Azithromycin Tablets (posted 25–Jan–2019)
• Bupropion Hydrochloride Extended-Release Tablets (posted 26–Dec–2019)
• Carbidopa and Levodopa Extended-Release Tablets (posted 26–Oct–2018)
• Chlorpromazine Hydrochloride Oral Concentrate (posted 18–Dec–2020)
• Chlorzoxazone Tablets (posted 22–Nov–2019)
• Diclofenac Sodium and Misoprostol Delayed-Release Tablets (posted 29–Mar–2019)
• Dihydroergotamine Mesylate Injection (posted 24–Apr–2020)
• Diltiazem Hydrochloride Extended-Release Capsules (posted 31–Jul–2020)
• Doxycycline Capsules (posted 24–Apr–2020)
• Dronedarone Tablets (posted 28–Dec–2018)
• Dronedarone Tablets (posted 29–May–2020)
• Entacapone Tablets (posted 29–Mar–2019)
• Estradiol Transdermal System (posted 28–Sep–2018)
• Estradiol Transdermal System (posted 29–May–2020)
• Extended Phenytoin Sodium Capsules (posted 26–Apr–2019)
• Lamotrigine Extended-Release Tablets (posted 28–Sep–2018)
• Lamotrigine Extended-Release Tablets (posted 25–Jan–2019)
• Levothyroxine Sodium Tablets (posted 28–Feb–2020)
• Levothyroxine Sodium Tablets (posted 24–Apr–2020)
• Metformin Hydrochloride Extended-Release Tablets (posted 28–Sep–2018)
• Metformin Hydrochloride Extended-Release Tablets (posted 31–May–2019; updated 04–Jun–2019)
• Metformin Hydrochloride Extended-Release Tablets (posted 22–Nov–2019)
• Metformin Hydrochloride Extended-Release Tablets (posted 31–Jan–2020)
• Metformin Hydrochloride Extended-Release Tablets (posted 29–May–2020)
• Metolazone Tablets (posted 18–Dec–2020)
• Metoprolol Succinate Extended-Release Tablets (posted 26–Jan–2018)
• Metoprolol Succinate Extended-Release Tablets (posted 26–Dec–2019)
• Methylphenidate Hydrochloride Extended-Release Tablets (posted 27–Jul–2018)
• Methylphenidate Hydrochloride Extended-Release Tablets (posted 25–Jan–2019)
• Minocycline Hydrochloride Extended-Release Tablets (posted 29–Mar–2019)
• Nicardipine Hydrochloride Injection (posted 26–Oct–2018)
• Nitrofurantoin Capsules (posted 30–Aug–2019)
• Olmesartan Medoxomil Tablets (posted 26–Jul–2019)
• Omeprazole Delayed-Release Capsules (posted 26–Dec–2019)
• Propranalol Hydrochloride Extended-Release Capsules (posted 27–Mar–2020)
• Quetiapine Extended-Release Tablets (posted 29–May–2020)
• Quetiapine Extended-Release Tablets (posted 18–Dec–2020)
• Ropivacaine Hydrochloride (posted 31–Jan–2020)
• Rufinamide Tablets (posted 28–Feb–2020)
• Sitagliptin Phosphate (posted 24–Apr–2020) 
• Sitagliptin Phosphate (posted 28–Aug–2020)
• Tacrolimus Capsules (posted 30–Nov–2018)
• Tacrolimus Capsules (posted 20–Nov–2020)
• Teriparatide (posted 29–May–2020)
• Teriparatide Injection (posted 29–May–2020)
• Thalidomide Capsules (posted 26–Apr–2019)
• Vancomycin Injection (posted 26–Jun–2020)
• Zolmitriptan Nasal Spray (posted 24–Apr–2020)

General Chapter Prospectus 

As part of a pilot process, USP Expert Committee members will develop a brief prospectus for new general chapters or major general chapter revisions prior to their publication in Pharmacopeial Forum (PF). The purpose of these is to solicit input during the early stages of general chapter development. The input received from the prospectus process will be considered as advisory only. Formal comments on subsequent PF proposals must be submitted separately at the time of publication in PF.

Below is a listing of the currently active general chapter prospectus notices:

• <567> Analysis of Contaminant Pyrrolizidine Alkaloids (PAs) (posted 25–Sep–2020; input deadline 30–Oct–2020)
• <1469> Nitrosamine Impurities (posted 24–Apr–2020; input deadline 22–May–2020)
• <1567> Pyrrolizidine Alkaloids (PAs) (posted 31–Jul–2020; input deadline 30–Aug–2020)
• <2800> Multi-Ingredient Dietary Supplement Products— Development of Quality Tests (posted 08–May–2020; input deadline 07–Jun–2020)
• Use of Recombinant Reagents in Bacterial Endotoxins Test (posted 29–May–2020; input deadline 28–Jun–2020)

Reference Changes

USP and its Expert Committees periodically deem it necessary to modify general chapter titles or similar text that may be referenced in other standards throughout the USP–NF. When this occurs, USP staff undertakes a rigorous process for identifying and updating such references. These updates may occur through a routine revision, or, in cases in which an update appears to present no significant change in the affected standard, through a direct update of the reference in that standard without providing an opportunity for notice and comment. In all cases, USP will publish on its website a notice indicating the source change, any resulting references, and whether those references will be updated through a routine revision or a direct update. Below is a listing of these notices and related information. Updates made through direct publication in the USP–NF will be clearly identified by symbols and shading in the print and electronic publications.

• Monographs Affected by Revision to <601> Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders—Performance Quality Tests (posted 02–Oct–2020)

Publications Announcements

• Impact of Extended Implementation of USP–NF Platform Starting on November 1, 2020 until December 1, 2020 (posted 23–Oct–2020) | En español
• USP–NF Online: Upcoming Corrections to Official Dates in History Tab and Banner (posted 15–Jan–2021)

USP–NF Redesigned Monographs

The downloadable Excel file below lists titles of monographs appearing in an official publication (USP–NF or Supplement) in the redesigned format. Monographs are redesigned either through USP’s revision process in the Pharmacopeial Forum (PF), accelerated revision, or as part of USP’s ongoing redesign process. The list can be sorted by monograph type, Expert Committee designation, or publication vehicle in which the monograph initially appeared in the redesigned format. This list is updated with the publication of each new USP–NF and Supplement. Currently, some drug substance monographs do not include the chemical structure of the article or may incorrectly include a structure in a dosage form monograph. As part of the redesign effort, the chemical structure of the article is being deleted or added to these monographs as an editorial change.

For questions regarding the redesign process, email redesign@usp.org.

• List of monographs appearing in redesigned format as of USP–NF 2021, Issue 1 (posted 25–Nov–2020)
• List of monographs appearing in redesigned format as of USP 43-NF 38 2S (posted 29–May–2020)