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 dietary supplement monographs. USP encourages you to submit draft monographs for the ingredients or finished products that 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 appropriate USP compendia. To participate,

  • Submit new draft monographs for dietary supplements
  • Review and comment on draft monographs published in the free PF and FCC Forums
  • Propose revisions to current dietary supplement monographs and procedures and submit data for proposed alternatives
  • Share with USP concerns about public comments on proposed new monographs and revisions published in the PF and FCC Forums

To learn about other opportunities for involvement, including Reference Standards development, visit the Dietary Supplement Donor Program information page.

Participant Benefits

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 dietary supplements
  • 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, data demonstrating that the procedure is stability indicating (if applicable), and results of analysis from three commercial batches. For complete details, please refer to the appropriate Guidance Documents listed below. The Guidance Documents are intended to aid the user. These tools are advisory only and do not affect the interpretation of any USP-developed compendium or publication. They are intended as recommendations only to be used to determine whether a monograph does or does not comply with USP's requirements. They do not confer any claims, rights, or guarantees that information submitted by a sponsor for a new or revised monograph will meet USP admission criteria.