Submission Guidelines

Stakeholders can ensure that they provide optimal submissions to USP and avoid publication delays by adhering to the following.

USP Guideline for Submitting Requests for Revision to the USP–NF: General Information for All Submissions

The Guideline for Submitting Requests for Revision to the USP–NF: General Information for All Submissions provides recommendations on submitting information and recommendations for developing new monographs or revising proposed or existing official monographs in the USP–NF. Revisions may be to an entire monograph or specific monograph tests, procedures, and/or acceptance criteria. USP also welcomes proposed revisions to general chapters and the General Notices and Requirements.

You can submit information for articles that are already FDA-approved or otherwise legally marketed. In certain cases, USP also works with manufacturers whose articles are undergoing clearance through the FDA review and approval process through our Pending Program.

Besides USP's General Information for All Submissions and General Notices to USP–NF, USP offers specific guidelines—some including what to expect after submission—for the following types of compendial articles. Where no link is provided, no specific guideline is available at this time.

Please note that a new version of Submission Guideline For Small Molecules is currently under development.

Additional Guidelines

  • USP Guideline on Use of Accelerated Processes for Revisions to the USP–NF: This guideline delineates the circumstances under which Errata, IRAs, and Revision Bulletins can be utilized to make revisions to the USP–NF official more quickly than through USP's standard revision process.
  • USP Guideline on Drugs Approved for Inclusion: Under the Medicare program administered by the Centers for Medicare and Medicaid Services (CMS), certain drugs and biologics are eligible for reimbursement only upon being designated as “approved for inclusion” in the USP.  This document includes background on the criteria for a product being “approved for inclusion” in the USP and provides manufacturers with guidelines on how to pursue the “approved for inclusion” designation for a newly approved product while a monograph is under development.
  • Pending Monographs Guideline: This approach enables web-based publication of monographs for articles (e.g., drug substances, excipients, and dosage forms) based on information in FDA applications and filings. The purpose of Pending Monographs is to have an official USP or NF monograph ready as soon as possible after FDA grants final product approval.
  • USP Guideline for Donors of USP Reference Standard Candidate Materials: USP’s Reference Standard program relies on the generosity of partners, who, as experts in the field, provide high-quality candidate materials intended for use in the development of official public standards. This describes the general requirements for supplying such materials to USP.