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Submission Guidelines

Revised July 24, 2009

USP's Guideline for Submitting Requests for Revision to the USP–NF (Revision Guideline) provides recommendations to Sponsors submitting information to support revisions to the USP–NF. Revision includes either creation of a new monograph or a revision to an official monograph. The purpose of this guideline is to promote optimal submissions and avoid delays. Download the guideline below for more information and details.

USP has updated the previous "Introduction" and "Glossary" sections of the USP Guideline for Submitting Requests for Revision, into a more informative and combined "General Information For All Submissions” section. USP also has updated the Monograph Submission Templates so they are in the redesigned monograph format. The intent of this update is to provide clarity on monograph submission policies and to provide user-friendly resources for submitting new monographs or revisions to existing monographs.

You may download the USP Revision Guideline in sections

Monograph Submission Checklist and Templates (UPDATED JULY 24, 2009)

Submitting Reference Standards

What's New

PF 35(6) Errata (10/30/09)

New official Text for October: 15 Revisions Bulletins (10/30/09)

PF 35(6), November-December 2009: Highlights and Stimuli Articles (10/23/09)

Admission Criteria and Safety Classification for Dietary Supplements Guideline (10/22/09)

Elemental Impurities Hot Topics information updated (10/13/09)

General Chapter <1151> Pharmaceutical Dosage Forms (10/06/09)

Heparin Hot Topics information updated (10/02/09)

New Official Text for September (09/29/09)

Pending Standards for the month of September (09/25/09)

PF 35(5) IRAs and Errata (08/31/09)

PF Redesign

Related Resources