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. 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. Manufacturers and suppliers wishing to export medicines to the U.S. should abide by U.S. law and U.S. FDA regulations, which specify USP–NF standards. In addition, USP works with the Pharmacopeial Discussion Group to harmonize to standards for international use. 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. A case study of developing a compendial standard for Lipitor will be discussed.

Pharmaceutical products and compendial standards

253rd National Meeting (2017)

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