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. Download 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 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.

Features

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

Users

  • Sponsors (individuals in an organization who are responsible for submitting data for monograph and reference material development)
  • USP staff

Get Started

  • 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 receive 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 2010, USP expanded its Donor Recognition Program. Now, 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 Shawn Dressman at sfd@usp.org or Randy Kiser at rwk@usp.org.