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.

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.