Submit Monographs and Revisions
Industry and stakeholder participation in USP's public standards-setting process is essential to the development of authoritative, relevant USP–NF monographs. You can help by submitting new monographs and revisions by following the information provided below. You can also review and comment on draft monographs published in Pharmacopeial Forum (PF).
To learn about other opportunities for involvement, including Reference Standards development, visit our Donor Program information page.
Submit New Monographs
USP encourages you to submit draft monographs for your non-complex and complex drug substances and dosage forms as well as excipients. Your draft monograph will become the starting point for the official public standard. USP staff will involve you in a process of public review and comment to refine and finalize these monographs for publication in the USP–NF. See a priority list of items for which USP requires monographs.
Monograph Submission Guideline
Review and download the complete Monograph Submission Guideline. USP would like you to include the following information in draft monographs that you submit:
- The United States Adopted Name of the drug product
- Identification procedures
- Water correction procedure, where appropriate
- Stability-indicating assay
Please submit your draft monographs or email your questions on submission to Randy Kiser, M.S., M.B.A., email@example.com.
Additional Requirements for Active Substances
- Heavy metals
- Organic volatile impurities
- Acceptance criteria for process impurities
- Acceptance criteria for degradation products
- Physical property check procedures
Additional Requirements for Dosage Forms
- Release testing, where appropriate
- Limits for degradation compounds
- Uniformity of dosage units
- Bacterial endotoxins, where appropriate