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 Pending Notice of Intent to Revise: Tacrolimus Capsules (posted 20–Nov–2020)
• New Notice of Intent to Revise: Lactobacillus Rhamnosus (posted 20–Nov–2020)
• New General Announcement: <1085.1> Use of Recombinant Reagents in the Bacterial Endotoxins Test: Comments Received from Stakeholders (posted 18–Nov–2020)
• New General Announcement: New Inhalation Product Monographs: Proposed Approach for Performance Tests using Non-standard Apparatus (posted 28–Aug–2020; comment deadline 30–Nov–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.

• <7> Labeling (posted 27–Mar–2020)
• <1085.1> Use of Recombinant Reagents in the Bacterial Endotoxins Test: Comments Received from Stakeholders (posted 18–Nov–2020)
• Comments Received from Stakeholders: Reporting Thresholds in USP–NF Monographs (posted 28–Feb–2020)
• Deferred Proposal: General Notices and Requirements, 5.60.40 Impurities that are Unusually Toxic and/or Mutagenic (posted 30–Sep–2020) 
• FDA Resources for Angiotensis II Receptor Blockers Voluntary Recall (posted 30–Aug–2019)
• First Draft of Roadmap for Addressing Element-Specific Chapters and Tests in Excipient Monographs (posted 05–Aug–2020)
• Monograph and Reference Standard Nomenclature Update for Glyceryl Monocaprylocaprate and Glyceryl Mono and Dicaprylocaprate (posted 24–Apr–2020; updated 26–Jun–2020)
• New Inhalation Product Monographs: Proposed Approach for Performance Tests using Non-standard Apparatus (posted 28–Aug–2020; comment deadline 30–Nov–2020)
• Revisions to Containers for Dispensing Capsules and Tablets (posted 01–Nov–2019)
• Standards Affected by Postponements of <795> Pharmaceutical Compounding— Nonsterile Preparations, <797> Pharmaceutical Compounding— Sterile Preparations, and <825> Radiopharmaceuticals— Preparation, Compounding, Dispensing, and Repackaging (posted 03–Feb–2020) 
• Update: Guidance on the Use of Recombinant Reagents for Bacterial Endotoxin Test (posted 28–Aug–2020)
• Update of Hydroxycloroquine Sulfate Monograph (posted 19–May–2020)
• Update: Reporting Thresholds in USP–NF Monographs (posted 12–Oct–2020)
• USP 43–NF 38— Last Print Edition (posted 04–Oct–2019)
• USP Provides Guidance on the Use of Recombinant Reagents for Bacterial Endotoxin Test (posted 29–May–2020; updated 30–Jul–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.

• Alcohol, Dehydrated Alcohol (posted 31–Jul–2020)
• Amantadine Hydrochloride (posted 27–May–2020)
• Aminocaproic Acid Oral Solution (posted 31–Jul–2020)
• Aprotinin and Aprotinin Injection Monographs (posted 24–Apr–2020)
• Aprepitant Capsules, Galantamine Tablets, Praziquantel Tablets, and <1092> The Dissolution Procedure: Development and Validation (posted 28–Aug–2020)
• Castor Oil (posted 31–Jul–2020)
• Cetyl Alcohol (posted 28–Feb–2020)
• Diphenhydramine Hydrochloride Oral Powder (posted 25–Sep–2020)
• Clonidine Transdermal System (posted 27–Mar–2020)
• Chapters Affected by Revision to <381> Elastomeric Closures for Injections (posted 22–May–2020)
• Chapters Affected by Revision to <1079> Risks and Mitigations Strategies for the Storage and Transportation of Finished Drug Products (posted 22–May–2020)
• Chapters Affected by Revision to <1087> Apparent Intrinsic Dissolution—Dissolution Testing Procedures for Rotating Disk and Stationary Disk (posted 22–May–2020)
• Chymotrypsin and Chymotrypsin for Ophthalmic Solution Monographs (posted 10–Apr–2020)
• Desmopressin Acetate (posted 30–Apr–2020)
• Dipivefrin Hydrochloride (posted 30–Apr–2020)
• Filgrastim (posted 10–Apr–2020)
• Gemfibrozil Tablets (posted 28–Aug–2020)
• ioversol (posted 28–Aug–2020)
• Ioversol Injection (posted 28–Aug–2020)
• Lactobacillus Rhamnosus (posted 20–Nov–2020)
• Loperamide Hydrochloride (posted 27–Mar–2020)
• Loperamide Hydrochloride (24–Apr–2020)
• Methyldopate Hydrochloride and Methyldopate Hydrochloride Injection (posted 23–Oct–2020)
• Metyrosine (posted 24–Apr–2020)
• Monographs Affected by Revision to <11> USP Reference Standards (posted 26-Dec–2019)
• Monographs Affected by Revision to <197> Spectroscopic Identification Test (posted 04–Oct–2019) | En español
• Monographs Affected by Revision to <561> Articles of Botanical Origin (posted 04–Oct–2019)
• Monographs Affected by Revision to <591> Zinc Determination (posted 04–Oct–2019)
• 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)
• Monographs Affected by Revision to <1046> Cellular and Tissue-Based Product (posted 04–Oct–2019)
• Monographs Affected by Revision to <1119> Near-Infrared Spectroscopy [New <1856> Near-Infrared Spectroscopy–Theory and Practice] (posted 04–Oct–2019)
• Monographs Affected by Revision to <1136> Packaging and Repackaging—Single Unit Containers (posted 04–Oct–2019)
• Monographs Affected by Revision to <1177> Good Packaging Practices (posted 04–Oct–2019)
• 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)
• Parachlorophenol (posted 15–Apr–2020)
• PF Online: Changes to Briefings (posted 02–Jan–2020)
• Ribose (posted 26–Jun–2020)
• Stearyl Alcohol (posted 28–Feb–2020)
• Sulfamethoxazole (posted 12–Jun–2020)
• Telmisartan and Amlodipine Tablets (posted 28–Feb–2020; updated 28–Aug–2020)
• Triamcinolone Acetonide Nasal Spray (posted 26–Jun–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)
• 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)
• Fluphenazine Hydrochloride Tablets (posted 24–Apr–2020)
• 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)
• 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)
• Metyrosine Capsules (posted 31–Jul–2020)
• 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)
• 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 <561> Articles of Botanical Origin (posted 04–Oct–2019)
• Monographs Affected by Revision to <591> Zinc Determination (posted 04–Oct–2019)
• Monographs Affected by Revision to <601> Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders—Performance Quality Tests (posted 02–Oct–2020)
• Monographs Affected by Revision to <1046> Cellular and Tissue-Based Product (posted 04–Oct–2019)
• Monographs Affected by Revision to <1119> Near-Infrared Spectroscopy [New <1856> Near-Infrared Spectroscopy–Theory and Practice] (posted 04–Oct–2019)
• Monographs Affected by Revision to <1136> Packaging and Repackaging—Single Unit Containers (posted 04–Oct–2019)
• Monographs Affected by Revision to <1177> Good Packaging Practices (posted 04–Oct–2019)
• 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)
• Standards Affected by Appeals to <795> Pharmaceutical Compounding — Nonsterile Preparations, <797> Pharmaceutical Compounding — Sterile Preparations, and <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging (posted 24–Apr–2020)

Publications Announcements

• Accelerated Revisions: Format Change (posted 29–May–2020)
• Addition of UNII Codes in USP 40–NF 35 Online (posted 28–Oct–2016)
• Chapters Affected by Revision to <381> Elastomeric Closures for Injections (posted 22–May–2020)
• Chapters Affected by Revision to <1079> Risks and Mitigations Strategies for the Storage and Transportation of Finished Drug Products (posted 22–May–2020)
• Chapters Affected by Revision to <1087> Apparent Intrinsic Dissolution—Dissolution Testing Procedures for Rotating Disk and Stationary Disk (posted 22–May–2020)
• Comment Deadline Extended: Pharmacopeial Forum 46(3) (posted 15–Jun–2020)
• Extended Implementation and Comment Period Extension for USP and FCC Publications (posted 27–Mar–2020; updated 31–Mar–2020; updated 24–Apr–2020) | En español
• First Supplement to USP 39–NF 34 Online: Errata Icon for GC <661.1> (posted 27–May–2016)
• Impact of Extended Implementation of USP–NF Platform Starting on November 1, 2020 until December 1, 2020 (posted 23–Oct–2020) | En español
• June 2016 and April 2016 USP–NF Errata Postings (posted 10–Jun–2016)
• June 2016 USP–NF Errata Posting (posted 24–Jun–2016)
• New USP-NF Online Launch and Delayed Implementation for Second Supplement to USP41-NF36 (posted 15–May–2018)
• New USP–NF Online: First and Second Supplement to USP 41–NF 36 Table of Contents (posted 29–Jun–2018)
• PF Online: Changes in Official Publication Targets (posted 17–Jul–2020)
• PF Online: Changes to Briefings (posted 02–Jan–2020)
• Pharmacopeial Forum 43(4) [Jul.–Aug. 2017]: Climbazole (posted 09–Nov–2017)
• Pharmacopeial Forum 44(2) [Mar.–Apr. 2018] Phytonadione Compounded Oral Suspension and Pyridostigmine Bromide Extended-Release Tablets (posted 23–Mar–2018)
• Removal of 3D Chemical Structures in USP–NF Online (posted 28–Oct–2016)
• Restoration of Display of USAN Adoption Dates (posted 12–Feb–20)
• Revisions to Containers for Dispensing Capsules and Tablets (posted 01–Nov–2019)
• Second Supplement to USP 39–NF 34 Online: Greek Symbols (posted 24–Jun–2016)
• Stage 4 Harmonization [April 2018]: Methylcellulose (posted 01–Jun–2018)
• Standards Affected by Appeals to <795> Pharmaceutical Compounding — Nonsterile Preparations, <797> Pharmaceutical Compounding — Sterile Preparations, and <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging (posted 24–Apr–2020)
• USAN 2016 (posted 19–Aug–2016)
• Update to Style for Latin Binomials for USP 40–NF 35 (posted 28–Oct–2016)
• USP 41–NF 36 Online Table of Contents: Admissions (posted 17–Nov–2017)
• USP Compounding Compendium (posted 05–Feb–2016)
• USP–NF Errata Table Correction (posted 04–Oct–2017)
• USP–NF Online: Official Date Correction to Mandelic Acid, Methylpyrrolidone, Monosodium Glutamate, and Colorimetric Solutions Introduction (posted 05–Apr–2019)
• USP–NF Online: Official Status Correction to Anhydrous Dibasic Calcium Phosphate (posted 28–Feb–2020)
• USP–NF Online: Official Status Correction to Desoxychloic Acid and Fluconazole Injection (posted 02–Aug–2019)
• USP–NF Online: Official Status Correction to Eriochrome Black T (posted 30–Aug–2019)
• USP–NF Online: Official Status Correction to Manganese Sulfate Injection (posted 27–Mar–2020)
• USP–NF Online: Official Status Correction to Purified Stearic Acid (posted 27–Mar–2020)
• USP–NF Online: Official Status Correction to Talc, Chlorhexidine Gluconate Oral Rinse, and Powdered Echinacea purpurea (posted 15–Nov–2019)
• USP–NF Online: Upcoming Planned Changes to Title and Format (posted 27–Mar–2020; updated 29–May–2020) | En español
• USP–NF Revision Symbols (posted 23–Feb–2018)

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)
• List of monographs appearing in redesigned format as of USP 43-NF 38 1S (posted 21-Feb-2020)
• List of monographs appearing in redesigned format as of USP 43-NF 38 (posted 01-Nov-2019)
• List of monographs appearing in redesigned format as of USP 42-NF 37 2S (posted 31-May-2019)
• List of monographs appearing in redesigned format as of USP 42-NF 37 1S (posted 25-Jan-2019)
• List of monographs appearing in redesigned format as of USP 42-NF 37 (posted 26–Oct–2018)
• List of monographs appearing in redesigned format as of USP 41–NF 36 2S (posted 18–Jun–2018)
• List of monographs appearing in redesigned format as of USP 41–NF 36 1S (posted 26–Jan–2018)
• List of monographs appearing in redesigned format as of USP 41–NF 36 (posted 27–October–2017)