Compendial Notices

Compendial Notices is designed to inform industry stakeholders of the changing status of USP Monographs and General Chapters. Compendial Notices includes General Announcements, Notices of Intent to Revise, and General Chapter status. Note that these postings are not official text. Postings, when expired, are moved to the “Retired Compendial Notices” section.

USP posts Compendial Notices by General Chapter (numerical order), then by Monograph name (alphabetical order). The “New” section includes the most recently posted Compendial Notices in chronological order.

New

Changes to the Dissolution Performance Verification Test (11/20/09)
USP 33-NF 28 Errata (posted 17-Nov-09)
Revision to USP Pending Monographs Guideline (posted 09–Nov–2009)
Prospective Harmonization (posted 09–Nov–2009)
USP Revised Admission Criteria and Safety Classification for Dietary Supplements (posted 22–Oct–2009)

General Announcements

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

<3> and <725> Topical and Transdermal Products - USP Forwards Proposed General Chapters on Topical and Transdermal Drug Products (posted 29-May-2009)
Metal Impurities Advisory Panel Recommendations to the General Chapters Expert Committee (28KB) (posted 02-June-2009)

<232> Elements and Limits
<233> Methods
<1232> Rationale for Metal Impurity Limits

<1121> Nomenclature: Monograph Naming Policy for Salt Drug Substances in Drug Products and Compounded Preparations (posted 04–Jun–2007; official 01–May–2013)
<1151> Pharmaceutical Dosage Forms (posted 6-October-2009)
Changes to the Dissolution Performance Verification Test (11/20/09)
Green Tea Cautionary Labeling Update (posted 10–Apr–2009)
Notice of Heparin Stage 2 Interim Revision Announcements (posted 24–Jun–2009)
Levothyroxine Sodium Tablets (posted 29–Aug–2008; official 03–Oct–2009)
Amended USP 32–NF 27 Commentary (posted 19–Mar–2009)
USP 33-NF 28 Errata (posted 13-Nov-09)
USP Revised Admission Criteria and Safety Classification for Dietary Supplements (posted 22–Oct–2009)
USP Revises its Request for Revision Guideline (posted 24–July–2009)

Notices of Intent to Revise

USP provides Intent to Revise Announcements to provide FDA and industry with notice of official text that is under revision.

<1> Injections: Notice of Intent to Revise (posted 29-Jul-2009)
<711> Dissolution (posted 11–Mar–2008)
Acitretin Capsules (posted 22–Jul–2009)
Galantamine Tablets: Notice of Intent to Revise (posted 12-Jun-2009)
Levalbuterol Hydrochloride (posted 29-May-2009)
Modafinil: Notice of Intent to Revise (posted 19-Jun-2009)
Modafinil Tablets: Notice of Intent to Revise (posted 19-Jun-2009)
Nefazodone Hydrochloride (posted 20–Mar–2009)
Tamsulosin Hydrochloride Capsules (posted 08–Apr–2009)

Publications Corrections

<381> Elastomeric Closures for Injections – Error in USP 32–NF 27 Publication Dates (posted 03–Dec–2008)

General Chapter Status

The General Chapters status page provides users with the status of General Chapter revisions. The status is revised every other month to coincide with the Pharmacopeial Forum publication schedule.