Contribute to new or revised USP Standards

USP's close collaboration with industry and regulators, along with public commenting, helps us prioritize the revision and development of new standards that can help protect the quality of medicines, foods, and dietary supplements.

In the area of medicines, the information, and materials that you contribute to the USP Donations Program will help set the standard for articles manufactured and marketed globally.

New Standards

Your contribution of methods, related information, and/or materials will help us continue to address evolving industry and public health needs. We are currently accepting contributions for Small Molecules, Peptides, Excipients, Food Ingredients, and Dietary Supplement Ingredients.


Revised Standards

We continuously revise USP Standards to stay current with industry changes.

Ways in which you may help include:

  • Submitting your current methods and related information

  • Providing the names of impurities and FDA-approved acceptance criteria to be incorporated into the revision developed by USP’s internal labs.

  • Providing reference material samples for USP’s Standards development.

  • Active proposals can be reviewed within the Pharmacopeial Forum.

Requests for revised standards can be found within our USP Prioritization List below.


USP Prioritization Lists (New and Revised)

We are seeking methods and related information to assist USP with developing quality standards that are not currently part of the official USP–NF, Food Chemicals Codex (FCC), or Dietary Supplements Compendium (DSC); please see the prioritization lists below.

If you would like to contribute but do not see your article on the list, please contact the Donations Program at Donations@USP.org.

Benefits of Contributing

When you contribute methods, related information and/or materials to the USP Donations Program, you collaborate with USP, industry and regulators to help set the standard for confirming the quality of medicines manufactured globally. This can improve regulatory predictability for your products, saving valuable time and resources.

Who can contribute?

  • Academic institutions

  • Compounding member support organizations

  • Compounding pharmacies

  • Pharmaceutical companies

  • Clinical and professional associations

  • Other organizations that meet US Expert Committee criteria for sufficient information for monograph creation

Get Started

To streamline your contribution and avoid publication delays, please adhere to the following guidelines.

Method and Related Information Guidelines

USP Recognizes Your Contributions

Your contribution plays a vital role in improving global public health by developing and ensuring the availability of quality standards in more than 130 countries across the world. You are a champion of quality. To demonstrate our appreciation for your valuable contributions, USP proudly acknowledges you within our Donor Recognition Program.

Learn More

Questions?

Below you will find the appropriate contacts to help you with your need:

  • For methods and related information along with physical material contribution inquiries, contact Donations@USP.org.
  • For Reference Standard contribution inquiries, contact Gregory E. Agoston at GEA@USP.org.
  • For Donor Recognition Program inquiries, contact Donorrecognition@USP.org.

Please reference our Method and Related Information Guidelines or the USP Reference Standard Candidate Materials Form for contributions. For any other inquiries, please contact Donations@USP.org.