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 Corrections
USP–NF Redesigned Monographs
Retired Compendial Notices

New Notices

New Pending Notice of Intent to Revise: Aminocaproic Acid Tablets (posted 28–Jun–2019)
New Pending Notice of Intent to Revise: Isosorbide Dinitrate Tablets (posted 28–Jun–2019)
New Pending Notice of Intent to Revise: Metformin Hydrochloride Extended-Release Tablets (posted 31–May–2019; updated 04–Jun–2019)

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.

Change to USP–NF Revision Mark-Up (posted 05–Oct–2018)
Compounding Compendium (posted 31–May–2019)
Expanded Monograph Omission Initiative (posted 17–Nov–2017)
General Chapter <7> Labeling (posted 25–Jan–2019)
General Notices and Requirements Nomenclature of Biologics Proposal Will be Deferred (posted 27–Apr–2018)
New USP-NF Online Launch and Delayed Implementation for Second Supplement to USP41-NF36 (posted 15–May–2018)
Omission of Levodopa Capsules Monograph (posted 01–Aug–2018)
Packaging Chapters Published in PF 44 (3) [May–Jun. 2017] to be Cancelled and Redeveloped (posted 23–Feb–2018)
Pharmacopeial Discussion Group Working Procedure Changes (posted 26–Jan–2018)
Reagent Cross References in USP–NF Project Continues (posted 25–Jan–2019)
Removal of UNII Codes in Excipient Monographs in USP 42–NF 37 Online (posted 31–Aug–2018)
USP–NF Online: Proposed Changes to Title and Format- Update (posted 25–Jan–2019)

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.

<191> Identification Tests— General (posted 27–Jul–2018)
<467> Residual Solvents (posted 22–Feb–2019)
<795> Pharmaceutical Compounding– Nonsterile Preparations (posted 30–Mar–2018)
<797> Pharmaceutical Compounding— Sterile Preparations (posted 27–Jul–2018)
<825> Radiopharmaceuticals— Preparation, Compounding, Dispensing, and Repackaging (posted 27–Jul–2018)
Alprazolam Tablets (posted 22–Feb–2019)
Atropine Sulfate Ophthalmic Ointment (posted 31–Aug–2018; retracted 04–Sep–2018)
Atropine Sulfate Ophthalmic Solution (posted 04–Sep–2018)
Cidofovir (posted 04–Mar–2019)
Cloxacillin Sodium Intramammary Infusion (posted 23–Feb–2018)
Dicloxacillin Sodium (posted 26–Feb–2016)
Dydrogesterone (posted 31–May–2019)
Fentanyl (posted 26–Apr–2019)
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets (posted 20–Jul–2018)
Formoterol Fumarate (posted 22–Feb–2019)
General Notices and Requirements (posted 29‒Sep‒2017)
Iohexol (posted 31–May–2019)
Miconazole Nitrate (posted 07–Mar–2019)
Monographs Affected by Revision to <7> Labeling (posted 05–Oct–2018)
Monographs Affected by Revision to <161> Medical Devices— Bacterial Endotoxin and Pyrogen Tests (posted 05–Oct–2018)
Monographs Affected by Revision to <561> Articles of Botanical Origin (posted 05–Oct–2018)
Monographs Affected by Revision to <855> Mephelometry, Turbidity, and Visual Comparison (posted 05–Oct–2018)
Monographs Affected by Revision to <1090> Assessment of Solid Oral Drug Product Performance and Interchangeability, Bioavailability, Bioequivalence, and Dissolution (posted 05–Oct–2018)
Revision of Selected Insulin Family Monographs (posted 27‒Apr‒2018)
Revisions to Elastomeric Components for Injections Chapters <381>, <382>, <1381>, and <1382> (posted 31–May–2019)
Naproxen Sodium and Pseudoephedrine Extended-Release Tablets (posted 01–Jun–2018; revised 04–Jun–2018)
Revisions to Plastic Packaging Chapters <659>, <661>, <661.1>, <661.2>, and <1661> (posted 26–Oct–2018; updated 28–Dec–2018)
Phytonadione (posted 27–Jul–2018)
Phytonadione (posted 28–Dec–2018)
Trihexyphenidyl Hydrochloride Oral Solution (posted 04–May–2016)
Trihexyphenidyl Hydrochloride Extended-Release Capsules (posted 04–May–2016)
Witch Hazel (posted 30–June–2017)

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)
Aminocaproic Acid Tablets (posted 31–May–2019)
Aminocaproic Acid Tablets (posted 28–Jun–2019)
Amlodipine and Atorvastatin Tablets (posted 26–Oct–2018)
Azithromycin Tablets (posted 25–Jan–2019)
Carbidopa and Levodopa Extended-Release Tablets (posted 26–Oct–2018)
Diclofenac Sodium and Misoprostol Delayed-Release Tablets (posted 29–Mar–2019)
Divalproex Sodium Extended-Release Tablets (posted 29–Mar–2019)
Dronedarone Tablets (posted 28–Dec–2018)
Entacapone Tablets (posted 29–Mar–2019)
Erythromycin Delayed-Release Tablets (posted 22–Feb–2019)
Estradiol Transdermal System (posted 28–Sep–2018)
Extended Phenytoin Capsules (posted 26–Apr–2019))
Lamotrigine Extended-Release Tablets (posted 28–Sep–2018)
Lamotrigine Extended-Release Tablets (posted 25–Jan–2019)
Metformin Hydrochloride Extended-Release Tablets (posted 31–May–2019; updated 04–Jun–2019)
Metoprolol Succinate Extended-Release Tablets (posted 26–Jan–2018)
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)
Penacillamine Capsules (posted 27‒Apr‒2018)
Potassium Chloride Extended-Release Capsules (posted 31–May–2019)
Potassium Chloride Extended-Release Tablets (posted 28–Sep–2018)
Potassium Chloride Extended-Release Tablets (posted 26–Oct–2018)
Propafenone Hydrochloride Extended-Release Capsules (posted 27‒Apr‒2018)
Tacrolimus Capsules (posted 30–Nov–2018)
Thalidomide Capsules (posted 26–Apr–2019)
Vancomycin Injection (posted 26–Oct–2018)

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:

<541> Titimetry (posted 29‒Sep‒2017)
<825> Compounding—Radiopharmaceuticals (posted 01–Jun–2017)
<922> Water Activity (posted 30–Mar–2018; deadline 30–Apr–2018)
<1085> Guidelines on Endotoxins Test (posted 26–Jan–2018)
<1153> Drug Products Containing Nanomaterials (posted 26–Apr–2019)
<1711> Oral Solid Dosage Forms - Dissolution Testing (posted 29‒Sep‒2017)
<1788> Methods for the Determination of Particulate Matter in Injections and Ophthalmic Solutions (posted 30–Mar–2018; comment deadline 30–Apr–2018)
<2740> Manufacturing Practices for Dietary Ingredients (posted 29‒Sep‒2017)
Evaluating Screening Technologies for Assessing Medicine Quality (posted 29–Dec–2017)
Supplier Qualification by User of Upstream Supply Chain for Pharmaceutical Excipients (posted 30–Mar–2018)
Using Mean Kinetic Temperature to Evaluate Temperature Excursions During Storage and Transportation (posted 26–Oct–2018)

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.

Changes to General Chapter Format and General Chapter Reference Format (posted 31–Jul–2015)
Clean-up of General Chapter References in USP 39–NF 34 (posted 31–Jul–2015; updated 28–Aug–2015)
Clean-up of General Chapter References in USP 40–NF 35 (posted 28–Oct–2016)
Monographs and GCs Affected by Revision to GC <1> Injections (posted 31–Jul–2015)
Monographs Affected by Revision to <7> Labeling (posted 05–Oct–2018)
Monographs Affected by Revision to <161> Medical Devices— Bacterial Endotoxin and Pyrogen Tests (posted 05–Oct–2018)
Monographs Affected by Revision to General Chapter <191> Identification Tests – General (posted 16–Mar–2015)
Monographs Affected by Revision to <191> Identification Tests– General (posted 27–Oct–2017)
Monographs and GCs Affected by Revisions to GC <231> Heavy Metals Revision Bulletin (posted 27–Mar–2015; official 01–Apr–2015; updated 12–May–2015)
Monographs Affected by Revision to Revision to <345> Assay for Citric Acid/Citrate and Phosphate (posted 27–Oct–2017)
Monograph Affected by the Revision of <531> Thiamine Assay (posted 28–Oct–2016)
Monographs Affected by Revision to <561> Articles of Botanical Origin (posted 05–Oct–2018)
Monographs Affected by Cross-References to Pesticide Residue Analysis in <561> Articles of Botanical Origin (posted 26–Oct–2018)
Monographs Affected by Revision to <591> Zinc Determination (posted 27–Oct–2017)
Monographs Affected by Revision to <659> Packaging and Storage (posted 28–Oct–2016)
Monographs and GCs Affected by Revisions to GC <601> (posted 25–Apr–2014)
Monographs and GCs Affected by Revision to GC <661> Containers—Plastics (posted 31–Jul–2015)
Monographs and GCs Affected by Revision to General Chapter <659> Packaging and Storage Requirements (posted 24–Apr–2015)
Monographs Affected by Revision to <659> Packaging and Storage (posted 28–Oct–2016)
Monographs Affected by Revision to <821> Radioactivity (posted 28–Oct–2016)
Monographs Affected by Revision to <855> Mephelometry, Turbidity, and Visual Comparison (posted 05–Oct–2018)
Monographs Affected by Revision to <1090> Assessment of Solid Oral Drug Product Performance and Interchangeability, Bioavailability, Bioequivalence, and Dissolution (posted 05–Oct–2018)
Monographs Affected by Revision to <1211> Sterility Assurance (posted 27–Oct–2017)
Monographs and General Chapters Affected by Revision to General Notices (posted 27–Oct–2017)
New Revision Markup for Reference Changes in USP–NF (posted 25–Jul–2014)

Publications Announcements

<7> Labeling (posted 26–Apr–2019)
Addition of UNII Codes in USP 40–NF 35 Online (posted 28–Oct–2016)
Comment Deadline Extended: Pharmacopeial Forum 44(6) and 45(1) (posted 30–Jan–2019)
First Supplement to USP 39–NF 34 Online: Errata Icon for GC <661.1> (posted 27–May–2016)
Integration of Accelerated Revisions into USP–NF Online (posted 18–Jun–2018)
June 2016 and April 2016 USP–NF Errata Postings (posted 10–Jun–2016)
June 2016 USP–NF Errata Posting (posted 24–Jun–2016)
Metformin Hydrochloride Extended-Release Tablets Online Correction (posted 16–Nov–2018)
New USP-NF Online Launch and Delayed Implementation for Second Supplement to USP41-NF36 (posted 15–May–2018)
New USP–NF Online, USP 41–NF 36 and Supplements: Cross-reference to Chromatography <621>, Thin-Layer Chromatography (posted 10–Aug–2018)
New USP–NF Online: First and Second Supplement to USP 41–NF 36 Table of Contents (posted 29–Jun–2018)
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)
Pharmacopeial Forum 44(3) [May–Jun. 2018]: Eriochrome Black T (posted 6–Jul–2018)
Removal of 3D Chemical Structures in USP–NF Online (posted 28–Oct–2016)
Second Supplement to USP 39–NF 34 Online: Greek Symbols (posted 24–Jun–2016)
Stage 4 Harmonization [April 2018]: Methylcellulose (posted 01–Jun–2018)
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 42–NF 37 Print, Online, and Flash Drive: Salix Species Bark, Salix Species Bark Dry Extract, and Salix Species Bark Powder (posted 11–Dec–2018)
USP Compounding Compendium (posted 05–Feb–2016)
USP–NF Errata Table Correction (posted 04–Oct–2017)
Correction: USP–NF Online: <191> Identification Tests—General, Chloride (posted 20–Nov–2018)
USP–NF Online: Official Date Correction to Mandelic Acid, Methylpyrrolidone, Monosodium Glutamate, and Colorimetric Solutions Introduction (posted 05–Apr–2019)
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 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)