United States Pharmacopeia
|This article does not cite any references or sources. (November 2013)|
|Headquarters||Rockville, Maryland, USA|
|Key people||Ronald T. Piervincenzi, Ph.D., Chief Executive Officer|
The United States Pharmacopeia (USP) is the official pharmacopeia of the United States, published dually with the National Formulary as the USP-NF. The United States Pharmacopeial Convention (usually also called the USP) is the nonprofit organization that owns the trademark and copyright to the USP-NF and publishes it every year. Prescription and over–the–counter medicines and other health care products sold in the United States are required to follow the standards in the USP-NF. USP also sets standards for food ingredients and dietary supplements.
Product quality–standards and verification
USP establishes written (documentary) and physical (reference) standards for medicines, food ingredients, dietary supplement products and ingredients. These standards are used by regulatory agencies and manufacturers to help to ensure that these products are of the appropriate identity, as well as strength, quality, purity, and consistency.
Prescription and over-the-counter medicines available in the United States must, by federal law, meet USP-NF public standards, where such standards exist. Many other countries use the USP-NF instead of issuing their own pharmacopeia, or to supplement their government pharmacopeia.
USP's standards for food ingredients can be found in its Food Chemicals Codex (FCC). The FCC is a compendium of standards used internationally for the quality and purity of food ingredients like preservatives, flavorings, colorings and nutrients. While the FCC is recognized in law in countries like Australia, Canada and New Zealand, it currently does not have broad legal recognition in the United States. USP obtained the FCC from the Institute of Medicine in 2006. The IOM had published the first five editions of the FCC.
USP also conducts verification programs for dietary supplement products and ingredients. These are testing and audit programs. Products that meet the requirements of the program can display the USP Verified Dietary Supplement Mark on their labels. This is different from seeing the letters “USP” alone on a dietary supplement label, which means that the manufacturer is claiming to adhere to USP standards. USP does not test such products as it does with USP Verified products.
USP develops information relating to various aspects of drug use and disseminates this information to practitioners, pharmacists, and others who make decisions about health care. One such initiative is the development of a drug classification system that Medicare Prescription Drug Benefit plans may use to develop their formularies. The USP Medicare Model Guidelines (USP MMG) are updated at the request of CMS, and are publicly available on the USP website. USP also plays a role in the naming of both pharmaceutical ingredients and products. This has a place in law via USP’s membership in the United States Adopted Names Council. The council is tri-sponsored by the American Medical Association, the American Pharmacists Association and USP.
Promoting the Quality of Medicines Program
The Promoting the Quality of Medicines (PQM) Program is a $35 million cooperative agreement with the U.S. Agency for International Development (USAID), a U.S. government agency. The program’s work is implemented by USP. Its purpose is to improve drug quality and the appropriate use of drugs in countries in Asia, Africa and Latin America. It is focused on medicines intended to treat malaria, HIV/AIDS and tuberculosis. Much of the PQM Program’s activities are designed to reduce the presence of substandard and counterfeit medicines, which pose threats to the lives of individual patients who take them and can contribute to growth of drug-resistant strains of these diseases.
International agreements and offices
USP works internationally, largely through agreements with other pharmacopeias, as well as regulatory bodies, manufacturer associations and others. In recent years, USP signed a series of Memoranda of Understanding (MOU) with groups including the pharmacopoeia Commission, the Chinese Pharmacopoeia Commission, nine countries belonging to the Association of Southeast Asian Nations (ASEAN), and the Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation (Roszdravnadzor). USP also operates an international office in Switzerland, and offices and laboratories in Brazil, India and China.
- British Pharmacopoeia
- European Pharmacopoeia
- National Formulary
- The International Pharmacopoeia
- Food and Drug Administration
- Genome Valley
- Pill splitting, for a discussion of USP standards concerning uniformity of dosage