Definitions

pharmacopeial

United States Pharmacopeia

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 widely recognized standards for food ingredients and dietary supplements. These standards ensure the quality, purity, strength, and consistency of products critical to the public health. USP's standards are recognized and used in more than 130 countries around the globe, and have helped to ensure public health throughout the world for close to 200 years.

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 contributions to public health are enriched 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.

Product Quality–Standards and Verification

USP establishes state–of–the–art documentary and reference standards to ensure quality medicines, food ingredients, and other health care products. Developed through a unique process of public involvement, standards setting is a core activity for USP. USP's 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) and its standards for food ingredients through the Food Chemicals Codex (FCC), as well as through official USP Reference Standards materials and Pharmacopeial Education courses USP also conducts verification programs for dietary supplement ingredients and products and pharmaceutical ingredients. These programs involve independent testing and review to verify ingredient and product integrity, purity, and potency for manufacturers who choose to participate.

Healthcare Information

USP develops authoritative, unbiased 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.

Patient Safety

USP operates two programs to promote safer care of patients who take medications and stay in hospitals. The Medication Errors Reporting Program allows healthcare professionals to directly report medication errors to USP. MEDMARX®, an Internet–based medication error and adverse drug reaction reporting program, is designed for use in hospitals and health systems. USP also uses its knowledge base to provide information that supports the healthcare community in the research and development of patient safety initiatives.

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. Four main programs that USP promotes are: ensuring drug quality by imparting its expertise in the field of 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, and furnishing technical leadership toward regional and international cooperation through USP's system of open conferences, Internet–based communications, and regular publications.

USP's Global Impact

Today, activities at USP are guided by a global approach to achieving its mission: to promote 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 a state-of-the-art laboratory. 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.

  • USP–China—Shanghai (China)

The China facility opened in the spring of 2006, with a full service office and laboratory that were formally inaugurated in September of 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.

  • USP-Brazil- Sao Paulo (Brazil)

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.

See also

Notes and references

JPE/JP - Japanese Pharmacopoeia

External links

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