| Type | non profit |
|---|---|
| Founded | 1820 |
| Headquarters |  Rockville, Maryland, USA |
| Key people | Roger L. Williams, M.D., Executive Vice President & Chief Executive Officer |
| Website | usp.org |
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) owns the trademark and copyright to the USP-NF and publishes it every 5 years. All prescription and over–the–counter medicines and other health care products manufactured or sold in the United States are standardized to the USP-NF. USP also sets recognized standards for food ingredients and dietary supplements. USP standards are recognized and used in more than 130 countries.
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Product quality–standards and verification
USP establishes documentary and reference standards to ensure quality medicines, food ingredients, and other health care products. These documentary standards and reference standards are used by regulatory agencies and manufacturers of pharmaceuticals, over–the–counter drugs, dietary supplements, and food ingredients to ensure that these products are of the appropriate strength, quality, and purity.
Prescription and over–the–counter medicines available in the United States must, by federal law, meet USP's public standards, where such standards exist. Many other countries use the USP instead of issuing their own pharmacopeia.
USP's standards for food ingredients can be found in the organization's Food Chemicals Codex (FCC). The FCC is a compendium of internationally recognized standards for the safety and purity of food ingredients like preservatives, flavorings, colorings and nutrients. While the FCC is broadly recognized in law in countries like Australia, Brazil, Canada and New Zealand, the FCC currently does not have any legal recognition in the United States. USP obtained the FCC from the Institute of Medicine in 2006, and the most recent version contains over 1,500 monographs for use by manufacturers and regulatory agencies.
USP also conducts verification programs for dietary supplement ingredients. Much like food ingredients, USP's standards for dietary supplements have no legal recognition in the United States, but involve independent testing and review to verify ingredient and product integrity, purity, and potency for manufacturers who choose to participate. The distinctive USP Verified Dietary Supplement Mark is awarded to finished dietary supplements that pass USP's verification processes. Manufacturers can display the mark only on the label of USP Verified products.
Healthcare information
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 around the world. Significant among USP's health care information initiatives is the development of a drug classification system that Medicare Prescription Drug Benefit plans may use to develop their formularies. USP also partners with the U.S. Agency for International Development, the World Health Organization, John Snow International, the Bill and Melinda Gates Foundation, and others in worldwide projects that help to assure drug quality and proper drug use in many developing countries.
Drug quality and information
USP's Drug Quality and Information (USP DQI) Program is a cooperative agreement with the United States Agency for International Development (USAID). The USP DQI program has established a presence in USAID–priority countries on four continents advancing strategies to improve drug quality and the appropriate use of drugs.
The four main programs that USP promotes:
- Ensuring drug quality by working with local governments, USAID missions, the World Health Organization (WHO), and other partners to evaluate a country's readiness and capacity to provide necessary drug quality assurance
- Providing continuing education for physicians, pharmacists and nurses in drug information and pharmacovigilance to help improve drug dispensing and ensure competence and accountability
- Developing and disseminating evidence–based drug and therapeutic information through targeted drug and therapeutic information materials for health care providers based on specific needs
- Establishing regional and international cooperation through USP's system of open conferences, Internet–based communications, and regular publications.
List of the editions
See also
- Food and Drug Administration
- MedlinePlus, for information of specific drugs
- National Formulary
- Pharmacopoeia
- The International Pharmacopoeia
- European Pharmacopoeia
- Pill splitting, for a discussion of USP standards concerning uniformity of dosage
Notes and references
External links
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This page was last modified on 27 February 2010 at 00:39.
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