USP & Regulators
USP works closely with government agencies, ministries, and regulatory authorities around the world to help provide standards of identity, quality, purity, and potency that can help safeguard the global supply of medicines, dietary supplements, and food ingredients. USP offers a variety of resources for regulatory professionals, including information about standards development and revisions, legal recognition of USP standards, and our international collaborations.
USP was established in 1820 to develop documentary standards of identity, quality, purity and strength for medicines being created and dispensed in the rapidly growing United States. Building on this legacy, USP has since expanded its standards-setting activities to include dietary supplements and food ingredients. USP also provides reference materials, carefully measured chemical and physical samples, for use in tests and methods to measure conformance to the documentary standards and quality assurance requirements. USP's standards are developed and revised under the leadership of volunteer experts from academia, industry, government, and other areas of healthcare and science who comprise USP's Council of Experts and Expert Committees.
Learn more about USP and our standards:
- About USP: history, leadership, impact and vision
- The Value of Standards
- Standards for medicines. View current compendial notices.
- Standards for dietary supplements
- Standards for food ingredients
- USP Reference Standards
In the U.S. and various other countries, USP standards are recognized in laws or accepted as a means of meeting certain regulatory criteria. Under the 1938 Food, Drug, and Cosmetic Act, prescription and over-the-counter medicines sold in the United States must comply with applicable quality standards published in the United States Pharmacopeia-National Formulary (USP-NF). USP also publishes widely observed quality standards for food ingredients in the Food Chemicals Codex; and for dietary supplements in the Dietary Supplements Compendium. Learn more:
USP has worked closely with the United States government since the early 19th century. That collaboration continues today as USP allies with the U.S. Food and Drug Administration (FDA) and other regulatory bodies around the world to help ensure the quality, safety, and benefit of medicines and foods. USP also works cooperatively with the U.S. Agency of International Development through the Promoting the Quality of Medicine (PQM) program to help developing countries increase the supply of quality assured medicines and combat substandard and counterfeit drugs.
Click on the links below to learn more about these and other global collaborations:
Official Comments & Letters
See USP Government Affairs for more information.
- USP Comments on FDA's New Dietary Ingredient Draft Guidance (02–Dec–2011)
- USP Comment on Draft Report by CDER Science Prioritization and Review Committee (02–Aug–2011)
- USP Comments on Updating Food Ingredient Regulations (20–Jun–2011)
- USP Comments on Food Safety Modernization Act (19–Apr–2011)
- USP Comment on Transparency (09–Apr–2010)
- USP Comment on Spices (01–Jun–2010)
- Letter from United States Senator Barbara A. Mikulski re. Food Chemicals Codex (26–May–2010)
USP hosts and participates in meetings, workshops, and courses around the world that encourage discussion on timely issues related to USP standards and initiatives and their role in protecting the global supply of medicines, foods, and dietary supplements. For an up-to-date listing of pending and past events, visit Meetings & Courses.
- USP's Quality Policy & ISO Accreditation
- USP Press Room
- Hot Topics
- USP Strategic Plan
- Monograph Backgrounder
- What is a Pharmacopeia?
- Did You Know?