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

Checklist for Submitting Requests for Revision to the USP–NF for New and Existing Small Molecules Monographs
Revision Request Form
Supporting Information for Dissolution / Drug Release / Disintegration Tests in USP Monographs
Adding New Dissolution tests to USP Monographs: Frequently Asked Questions
Pending Monographs Guidelines: 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.

Excipients

Excipients request for revision guidelines Substances other than the active pharmaceutical ingredient (API) that are intentionally included in an approved drug delivery system or a finished drug product.

Biologics

Path forward and stakeholder engagement: Biologics Standards Development

Dietary supplements, herbal medicines and food ingredients

Botanical Dietary Supplements: Botanical drugs, botanical dietary supplements, and herbal medicine ingredients
Non-Botanical Dietary Supplements: Vitamins, minerals, amino acids, and specialty ingredients (e.g., chondroitin, creatine, probiotics).
Admission of Dietary Supplement Ingredients to the USP–NF Monograph Development Process: Criteria used to determine whether a dietary ingredient qualifies for admission to the USP–NF process for quality monograph development.
Food Ingredients Monographs: Foods, food additives, food colors, processing aids (e.g., enzymes), and functional ingredients that affect the human body.
FCC Revisions
FCC Submission Checklist
Guideline for Assigning Titles to USP Dietary Supplement Monographs
This Guideline streamlines the naming of dietary supplement (DS) monograph articles in the USP–NF and in the DSC. It provides a documented, systematic approach to developing monograph titles for dietary ingredients and dietary supplement dosage forms newly admitted to USP. To minimize the potential for confusion and controversy, the nomenclature approach is informed by the practices of the dietary supplement industry and the labeling requirements of applicable federal regulations.

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

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.