Ensuring global access to quality medicines: role of the US Pharmacopeia

Abstract

In the 5-year cycle that characterizes a continuous improvement of the US Pharmacopeial (USP) Convention, the Council of the Convention's Section on Global Public Health worked with USP's staff to assess USP's international contributions to date and to consider opportunities for expanding activities that help to ensure good healthcare around the globe.1 This article reviews USP's process and product standards that are used worldwide to ensure the quality of medicines and dietary supplements and to help mitigate the burden of counterfeit and substandard ingredients and products. The article also reviews USP's international programs during the past 5-year cycle, along with continuing and planned international activities.

Keywords: US Pharmacopeial Convention; formulation; international health; quality; regulatory science; stability; therapeutic drug monitoring.