Get Involved in Setting USP–NF Standards
Participation in USP's public standards-setting process by the pharmaceutical industry and other stakeholders is vital to the development of authoritative, relevant USP–NF monographs. Interested parties can participate in any of the following ways
- Submit new draft monographs for chemical and biological drug substances and dosage forms.
- Review and comment on draft monographs published in the Pharmacopeial Forum.
- Propose revisions to monographs and procedures in the current official edition of USP–NF and submit data for proposed alternatives.
- Submit Reference Standards as indicated in the USP Guideline for Suppliers of Reference Standard Materials.
- Follow requirements and process for USP Guideline on Drugs Approved for Inclusion.
Database Tools for Priority New Monographs and Monograph Modernization
USP Donor Submission Portal
USP is pleased to announce the Donor Submission Portal (DSP). It is a secure, user-friendly, and interactive electronic platform for the exchange of information between sponsors and USP, in particular the transfer of monograph and reference material data to USP’s Standards Acquisition Department. Monograph and reference material acquisition is the first step in developing a public standard, and the Donor Submission Portal is designed to further facilitate and encourage participation in the USP standards-setting process.
The DSP's features allow sponsors to do the following in a safe, secure, and confidential website:
- Search for monographs of interest
- Submit documents in various formats for the development of a monograph
- Track progress of their submissions
- Discuss acquisition activities with the Standards Acquisition manager responsible for their submission
- View and share the compendial work of their organization
- Track their company's compendial activities for reporting to management and project planning
- Discuss standards-setting topics in a discussion forum
- Sponsors (individuals in an organization who are responsible for submitting data for monograph and reference material development)
- USP staff
- Click on https://donors.usp.org to access the Portal or request access (you may wish to consult your organization's compendial point of contact first)
- Training tutorial and other resources are available within the Portal.
USP Donor Recognition Program
USP appreciates industry participation and acknowledges the important role it plays in our standards–setting activities. Donors of monographs and candidate reference materials may receive, at their discretion, Certificates of Appreciation when monographs reach the publication stage or when donated reference materials reach the USP Catalog. Reference material donors also get a summary of the data collected by USP on their candidate material.
In addition to certificates, donors may receive (based on level of participation and donation status)
- Recognition in USP publications
- Complimentary workshop registrations
- Complimentary print subscription to either USP–NF, Food Chemicals Codex, or Dietary Supplements Compendium
- One-year, multiple–user license of electronic USP–NF or FCC
- Complimentary USP Reference Standards