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.
- Small Molecules and Excipients Guidelines
- Checklist for Submitting Requests for Revisions to the USP
- Small Molecules: Drug substances and products
- Revision Request Form
- Excipients: Substances other than the active pharmaceutical ingredient that are intentionally included in an approved drug delivery system or a finished drug product
- Approach to Biologics Standards: Path forward for standards development and early stakeholders engagement
- Dietary Supplements, Herbal Medicines, and Food Ingredient Guidelines
- 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 and other revisions to FCC: Foods, food additives, food colors, processing aids (e.g., enzymes), and functional ingredients that affect the human body. Also, view FCC submission checklist.
- Guideline for Assigning Titles to USP Dietary Supplement Monographs:This Guideline streamlines the naming of DS monograph articles in the USP–NF and in the DSC. It provides a written systematic approach to developing monograph titles for dietary ingredients and dietary supplement dosage forms newly admitted to USP. In order 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 Donation Checklist
- 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.