USP–NF 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
• 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

• Notice of Publication Error: USP 40‒NF 35 Second Supplement: Timolol Maleate (posted 30‒Jun‒2017)
• Notice of Intent to Revise: Salix Species Bark (posted 30–Jun–2017)
• Notice of Intent to Revise: Salix Species Bark Powder (posted 30–Jun–2017)
• Notice of Intent to Revise: Salix Species Bark Dry Extract (posted 30–Jun–2017)
• Notice of Intent to Revise: General Chapter <561> Articles of Botanical Origin (posted 30–Jun–2017)  
• Notice of Intent to Revise: Witch Hazel (posted 30‒Jun‒2017)
• USP 40–NF 35: General Chapter <191> Notice (posted 01–Jun–2017)
• General Chapter Prospectus: <825> Compounding—Radiopharmaceuticals (posted 01–Jun–2017; deadline 31-Aug-2017)

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.

• Notice of Publication Error: USP 40‒NF 35 Second Supplement: Timolol Maleate (posted 30‒Jun‒2017)
• USP 40–NF 35: General Chapter <191> Notice (posted 01–Jun–2017)
• <797> Pharmaceutical Compounding—Sterile Preparations to be Republished in Pharmacopeial Forum for Public Comment (posted 27–Jan–2017)
• Changes to General Chapter Format and General Chapter Reference Format (posted 31–Jul–2015)
• Changes to Pending Monographs Program (posted 29–May–2015)
• Cumulative List of USP–NF Revision Now Available (posted 29–Jul–2016)
• Early Input Sought on Proposed Naturally Occurring Endoxtoxin (NOE) Reference Standard (posted 27–May–2016)
• Comment Deadline for Pharmacopeial Forum 43(2) Extended (posted 23‒May‒2017)
• Reagent Cross References in USP–NF (posted 31–Jul–2015)
• USP to Pilot Process for Early Input on General Chapters (posted 26–Feb–2016)
• Stimuli to the Revision Process: Proposed New USP General Chapter: The Analytical Procedure Lifecycle <1220> (posted 14–Oct–2016)

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.

• <1> Injections and Implanted Drug Products (Parenterals)—Product Quality Tests (posted 26–Feb–2016)
• <561> Articles of Botanical Origin (posted 30–Jun–2017)  
• <661> Plastic Packaging Systems and Their Materials of Construction (posted 31–Mar–2017)
• <661.2> Plastic Packaging Systems for Pharmaceutical Use (posted 31–Mar–2017)
• <661.1> Plastic Materials of Construction (posted 31–Mar–2017)
• <659> Packaging and Storage Requirements (posted 31–Mar–2017)
• <797> Pharmaceutical Compounding—Sterile Preparations (posted 25–Sep–2015)
• <800> Hazardous Drugs—Handling in Healthcare Settings (15–Apr–2016; updated 29–Apr–2016)
• <1160> Pharmaceutical Calculations in Prescription Compounding (posted 25–Apr–2014)
• <1168> Compounding for Phase I Investigational Studies (posted 28‒Apr‒2017)
• Almotriptan Malate (posted 08–Jul–2016; updated 26–Aug–2016)
• Clindamycin Phosphate (posted 24‒Feb‒2017)
• Cloxacillin Sodium (posted 26–Feb–2016)
• Dextromethorphan (posted 28–Feb–2014; updated 01–Dec–2016)
• Dextromethorphan Hydrobromide (posted 28–Feb–2014; updated 01–Dec–2016)
• Dicloxacillin Sodium (posted 26–Feb–2016)
• Diphenhydramine Hydrochloride Monographs (posted 01–Feb–2016; updated 26–Feb–2016)
• Doxorubicin Hydrochloride Injection (posted 26–Feb–2016)
• Doxycycline Hyclate Tablets (posted 10‒Apr‒2017)
• Doxycycline Hyclate Capsules (posted 10‒Apr‒2017)
• Dutasteride (posted 29–Jul–2016; updated 01–Dec–2016)
• Krill Oil (posted 28‒Apr‒2017)
• Levocetirizine Dihydrochloride (posted 30–Dec–2016)
• Liothyronine Sodium (posted 18–Dec–2015)
• Methylcobalamin (posted 31–Mar–2017)
• Methylcobalamin Tablets (posted 31–Mar–2017)
• Nicotine Polacrilex (posted 10‒Apr‒2017)
• Phenylephrine Hydrochloride Monographs (posted 01–Feb–2016)
• Promethazine Hydrochloride Oral Solution (posted 18–Nov–2016)
• Pyridostigmine Bromide Tablets (posted 30–Dec–2016)
• Salix Species Bark (posted 30–Jun–2017)
• Salix Species Bark Powder (posted 30–Jun–2017)
• Salix Species Bark Dry Extract (posted 30–Jun–2017)
• Selamectin (posted 31‒Mar‒2017)
• Theophylline Oral Solution (posted 18–Nov–2016)
• Trihexyphenidyl Hydrochloride Oral Solution (posted 04–May–2016)
• Trihexyphenidyl Hydrochloride Extended-Release Capsules (posted 04–May–2016)
• Topiramate (posted 26–Aug–2016)
• Valine (posted 30–Dec–2016)
• Witch Hazel (posted 30‒Jun‒2017)

Notices of Intent to Revise: Pending Monograph Program

For more information please see the Pending Monograph Program webpage

• Metronidazole Gel (Pending) (posted 26–May–2017)

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:

• <825> Compounding—Radiopharmaceuticals (posted 01-Jun-2017; deadline 31‒Aug‒2017)
• <1079> Good Storage and Distribution Practices for Drug Products (posted 28‒Apr‒2017)

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 General Chapter <191> Identification Tests – General (posted 16–Mar–2015)
• 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)
• Monograph Affected by the Revision of <531> Thiamine Assay (posted 28–Oct–2016)
• 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)
• New Revision Markup for Reference Changes in USP–NF (posted 25–Jul–2014)

Publications Corrections

• Notice of Publication Error: USP 40‒NF 35 Second Supplement: Timolol Maleate (posted 30‒Jun‒2017)
• Addition of UNII Codes in USP 40–NF 35 Online (posted 28–Oct–2016)
• Removal of 3D Chemical Structures in USP–NF Online (posted 28–Oct–2016)
• Update to Style for Latin Binomials for USP 40–NF 35 (posted 28–Oct–2016)
• USAN 2016 (posted 19–Aug–2016)
• June 2016 USP–NF Errata Posting (posted 24–Jun–2016)
• Second Supplement to USP 39–NF 34 Online: Greek Symbols (posted 24–Jun–2016)
• June 2016 and April 2016 USP–NF Errata Postings (posted 10–Jun–2016)
• First Supplement to USP 39–NF 34 Online: Errata Icon for GC <661.1> (posted 27–May–2016)
• USP Compounding Compendium (posted 05–Feb–2016)

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 40 2S (posted 26-May-2017)