For nearly 200 years, USP has set scientifically developed standards that help to ensure that over-the-counter and prescription medicines are of high quality, are pure, are of the appropriate and expected strength, and are consistent from one pill, bottle, shelf, and pharmacy to the next. Once USP develops a drug standard and it becomes official, it is enforceable by the Food and Drug Administration (FDA), and all manufacturers of that drug must comply with the USP standard if they wish to import it to or market it in the United States. Note: USP does not approve a drug for sale in the U.S. market nor does it make decisions about a drug's safety or efficacy—these are also responsibilities of FDA.
Updating Standards for "At Risk" Medications
An important and emerging activity for USP is updating standards for drugs that are considered "at risk" for adulteration. In the modern, global manufacturing environment, drugs and their ingredients are produced all over the world. In some instances, counterfeiters have adulterated medicines by substituting lower-cost ingredients for higher-cost ones for their own economic gain—which can have serious and even fatal consequences for patients. Adherence to USP's standards of quality is one of the safety nets that helps secure the drug supply.
- Quality of OTC Medicines, Ingredients Critical to Patients
- USP Around the World
- Strengthened Glycerin Standard to Help Protect Consumers from Poisoned Products
Drug Classification for Medicare Prescription Drug Benefit
Under a Congressional mandate, USP has developed—and will continue to update—a drug classification system (the Medicare Model Guidelines) for the Medicare prescription drug benefit program. This classification system provides a framework that pharmaceutical benefit managers and prescription drug plan sponsors can use in determining medicines approved for coverage under Medicare.
USP Promoting the Quality of Medicines Program (PQM)
The effects of substandard and counterfeit medicines are devastating, and in developing countries where resources to combat them are limited, their impact is hardest felt. PQM is a program supported by the U.S. Agency for International Development (USAID) that focuses on helping developing countries ensure the quality, safety, and efficacy of medicines essential to USAID priority diseases, particularly malaria, HIV/AIDS, and tuberculosis. In addition to providing technical leadership and global advocacy, PQM helps countries improve their quality assurance and quality control systems, increase the supply of quality assured medicines, and combat substandard and counterfeit medicines.