The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.
Since its founding in 1820, USP has helped secure the quality of the American drug supply. Building on that legacy, USP today works with scientists, practitioners, and regulators of many nations to develop and revise standards that help protect public health worldwide.
Legal Recognition of USP Standards
While not a government entity, USP works closely with government agencies, ministries, and regulatory authorities around the world to help provide standards of identity, strength, quality, and purity that can help safeguard the global supply of medicines, dietary supplements, and food ingredients. In the U.S. and various other countries, USP standards are recognized in laws or accepted as a means of meeting certain regulatory criteria.
USP in U.S. Law
USP standards are recognized in a variety of U.S. federal legislation. USP’s drug standards are specified in the adulteration and misbranding provisions of the Federal Food, Drug, and Cosmetic Act; the Dietary Supplement Health and Education Act (DSHEA) misbranding provision has a role for USP’s dietary supplement standards; and more than 200 FDA regulations incorporate USP food ingredient standards. Learn more.
Today, USP standards are used in more than 140 countries around the world. Some international regulatory authorities and governments have incorporated our standards into their laws and regulatory provisions to help protect the quality of products and ingredients produced in or exported to their countries. Learn more.