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.
The Promoting the Quality of Medicines (PQM) program is funded by the United States Agency for International Development (USAID) and implemented globally by USP. Since 1992, USP has worked in partnership with USAID to support developing countries in addressing critical issues related to medicines quality. The PQM program provides technical assistance to build capacity of medicines regulatory authorities and quality assurance systems in countries with emergent health systems and it supports manufacturing of quality-assured priority essential medicines for malaria, HIV/AIDS, tuberculosis, neglected tropical diseases, and maternal and child health. There is increasing recognition of the burden of poor-quality medicines and their threat to public health, especially in low- and middle-income countries. Falsified and substandard medicines can cause treatment failure and adverse reactions, can increase morbidity and mortality, and may contribute to antimicrobial resistance. These medicines represent not only a waste of scarce resources but also a substantial risk to public health. Further, they risk undermining decades of health investments, including those made by USAID.