Submit Monographs & Revisions
Participation in USP's public standards-setting process by industry and other stakeholders is vital to the development of authoritative and relevant FCC food ingredient monographs. USP encourages you to submit draft monographs for the food ingredients you manufacture or supply. Your draft monograph will become the starting point for the public standard. USP staff will involve you in the public process review and comment to refine and finalize the monograph for publication in the next FCC edition or supplement. To participate,
- Submit new draft monographs for food ingredients that are not yet in the FCC.
- Review and comment on draft monographs published in the FCC Forum.
- Propose revisions to current FCC monographs and procedures and submit data for proposed alternatives.
To learn about other opportunities for involvement, including Reference Standards development, visit the Food Ingredients Donor Program information page.
Submitting draft monographs and revisions to USP lets you
- Contribute to the development of quality standards and procedures for your industry
- Engage in process and procedural changes and offer expertise on food ingredients
- Minimize the flow of adulterated or substandard articles
- Demonstrate your commitment to quality in public health
Submission Process and Guidelines
All submissions should include analytical validation data, and results of analysis from three commercial batches. For complete details, please refer to the FCC Guideline Documents below. USP's FCC team is available to answer questions and guide you through the process of public review and comment to refine and finalize your submissions. Contact the team at firstname.lastname@example.org.
FCC Guideline Documents
- Guideline for New FCC Monograph Submissions
- Guideline for FCC Revisions
- Guideline for FCC Provisional Standards
- Guideline for Submitting Requests for Revision to the FCC
- USP Guideline on Use of Accelerated Processes for Revisions to the Food Chemicals Codex
The FCC Guideline Documents are intended to aid the FCC user. These tools are advisory only and do not affect the interpretation of the FCC or any other USP-developed compendium or publication. These documents are recommendations only to be used to determine whether a monograph does or does not comply with USP's requirements, nor do they confer any claims, rights, or guarantees that information submitted by a sponsor for a new or revised monograph will meet FCC admission criteria.