Get Involved in Establishing USP Reference Standards

Establishing USP Reference Standards involves the voluntary cooperation of three groups: industry, government, and USP. Industry can participate in the process in the following ways:

  • By supplying a bulk quantity of drug substances, dosage forms, excipients, or other material to support documentary standards or monographs. These materials will serve as candidates for official USP Reference Standards. Access the USP Guideline for Suppliers of Reference Standard Materials.
  • By testing candidate materials provided by USP in your laboratories. This testing is integral to USP's characterization of USP Reference Standards.

To assist participants through each step of the process, USP has a dedicated Standards Acquisition team of scientists and support staff. Contact the team at stacq@usp.org.

USP also offers opportunities for involvement on the USP Council of Experts as well as with the donation of monographs for medicines, dietary supplements, and food ingredients.

The Reference Standards Development Process

Establishing a USP Reference Standard begins with the need for bulk material stemming from the development of a new monograph, a new application of an existing monograph or standard, or depletion of current inventory. Once USP has acquired a bulk material donation from a manufacturer, the material undergoes rigorous, collaborative testing by at least three laboratories. Read more about the development process.

Participant Benefits

Industry involvement in the USP Reference Standards Program is critical to producing the best reference materials. Supplying bulk candidate materials and/or providing testing services for USP Reference Standards helps you:

  • Qualify for tax benefits for the value of the materials you donate to USP
  • Prepare for regulator inspections, based on familiarity with official requirements
  • Contribute to quality in public health worldwide by helping to ensure the continuous availability of Reference Standards
  • Interact with USP's expert staff and volunteer scientists who can guide you in enhancing your internal quality control processes

USP is also interested in your ideas for new Reference Standards. To submit an idea, click here.

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):

Questions about the USP Donor Recognition Program should be addressed to Bruk Alemayehu at bka@usp.org or Randy Kiser at rwk@usp.org.