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United States Pharmacopeia
Type Nongovernmental, non profit Public health organization
Founded 1820
Headquarters Flag of the United States.svg Rockville, Maryland, USA
Key people Roger L. Williams, M.D., Executive Vice President & Chief Executive Officer
Website www.usp.org

The United States Pharmacopeia is an official public standards–setting authority for all prescription and over–the–counter medicines and other health care products manufactured or sold in the United States. USP also sets recognized standards for food ingredients and dietary supplements. These standards help to ensure the quality, purity, strength, and consistency of products made for public consumption. USP's standards are recognized and used in more than 130 countries around the globe.[1]

USP is a non-governmental, not-for-profit public health organization whose independent, volunteer experts work under strict conflict–of–interest rules to set its scientific standards. USP's work is aided by the participation and oversight of volunteers representing pharmacy, medicine, and other health care professions as well as academia, government, the pharmaceutical and food industries, health plans, and consumer organizations.

Contents

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 require the use of high–quality standards such as USP's to assure the quality of medicines and related products. USP disseminates its standards for medicines to pharmaceutical manufacturers, pharmacists, and other users through its United States Pharmacopeia–National Formulary (USP–NF) as well as through official USP Reference Standards materials and Pharmacopeial Education courses.

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
  • Establishing regional and international cooperation through USP's system of open conferences, Internet–based communications, and regular publications.

USP's global presence

Activities at USP are focused on promoting the public health by disseminating authoritative standards and information for over-the-counter medicines, dietary supplements, food ingredients and other health care technologies, and related practices used to maintain and improve health and promote optimal health care delivery around the world. USP's worldwide operations take place at the following locations:

  • USP Global Headquarters—Rockville, Maryland (USA)

Established in 1820 in Washington, D.C., USP has made its home in several cities in the U.S. In 1989, USP moved into its current location in Rockville, Maryland. USP headquarters is currently home to more than 450 employees; executive offices and meeting facilities; a full-service laboratory; publication and reference standards fulfillment; and a multilingual customer service center.

  • USP Europe, Middle East, Africa—Basel (Switzerland)

In September 2005, USP physically expanded its global presence with the opening of a service center in Basel. The USP staff in Basel is focused on fostering collaborative customer relationships, promoting pharmacopeial education, and increasing USP's reach throughout Europe, the Middle East, and Africa.

  • USP–India Private Limited—Hyderabad (India)

USP officially opened the India facility in Hyderabad in February 2006. The site houses a service office along with laboratory space. The USP-India staff works closely with the Indian Pharmacopeia and pharmaceutical manufactures to promote the manufacture and use of good-quality medicines, dietary supplements, and their ingredients.

The China facility opened in the spring of 2006, with a full service office and laboratory that were formally inaugurated in September 2007. USP-China is focused on working with manufacturers to promote good quality therapeutics; supporting distributors through local customer service, technical assistance and educational outreach; encouraging participation in USP's reference standards and verification programs; and generating awareness of global assistance programs.

The Brazil facility opened in August 2008. The facility includes a laboratory and office, which provide direct-to-customer technical service and assistance with USP’s documentary and reference standards, customized professional education (PE) programs, and verification programs and a collaborative testing laboratory. The space is about 1,700 square meters, and will serve customers across Latin America.

List of the editions

See also

Notes and references

JPE/JP - Japanese Pharmacopoeia

External links

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