Monograph Submission Guideline

Revised May 27, 2011

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

• General Information For All Submissions (UPDATED May 27, 2011) 
• Small Molecule Drug Substances and Products
• Excipients
• Biologics and Biotechnology Drug Substances or Products
• Vaccines
• Blood, Plasma, and Cellular Blood Components
• Revision History (UPDATED May 27, 2011)

Monograph Submission Checklist and Templates (UPDATED March 31, 2011)

• USP Submission Checklist
• Drug Substance and Excipient Template
• Emulsion
• Tablets and Capsules Template
• Injection and for Injection Template
• Oral Solution Template
• Cream and Ointment Template
• Topical Suspension Template
• Transdermal Delivery System Template

Submitting Reference Standards

• USP Guideline for Suppliers of Reference Standard Materials