Methods and Related Information Guidelines

The Guideline for Submitting Requests for Revision to the USP–NF: General Information for All Submissions provides more specific details on contributing information, developing new monographs, or revising proposed or official monographs in the USP–NF. Revisions can range from an entire monograph to specific monograph tests, procedures, and/or acceptance criteria. USP also welcomes proposed revisions to General Chapters and the General Notices and Requirements.

You can contribute 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 USP Donations Program.

Small Molecules


Excipients


Biologics


Dietary supplements, herbal medicines and food ingredients


Compounded Preparation Monograph

  • USP Compounding Monograph Checklist

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 revise the official USP–NF 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.
  • USP Guideline for Contributors 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.

USP Prioritization Lists

We are urgently seeking methods and related information to assist USP with developing quality standards that are not currently part of the official USP–NF, Food Chemicals Codex (FCC), or Dietary Supplements Compendium (DSC); please see the prioritization lists below.

If you would like to contribute but do not see your article on the list, please contact the USP Donations Program at Donations@USP.org.

USP Recognizes Your Contributions

USP Recognizes Your Contributions

Your contributions are vital to developing and ensuring the availability of quality standards trusted in more than 130 countries across the world to protect public health. You are a champion of quality. To demonstrate our appreciation for your valuable contributions, USP proudly acknowledges you within our Donor Recognition Program.

Learn More

Questions?

Please reference our Method and Related Information Guidelines or the USP Reference Standard Candidate Materials Form for contributions. For questions and additional details, please reach out to the appropriate contacts listed below:

  • For methods and related information, along with physical material contribution inquiries, contact Donations@USP.org
  • For Reference Standard contribution inquiries, contact Gregory E. Agoston at GEA@USP.org.
  • For Donor Recognition Program inquiries, contact Donorrecognition@USP.org.

For any other inquiries, please contact Donations@USP.org.