The ''United States Pharmacopeia'' (''USP'') is a

pharmacopeia A pharmacopoeia, pharmacopeia, or pharmacopoea (from the obsolete typography ''pharmacopœia'', meaning "drug-making"), in its modern technical sense, is a book containing directions for the identification of compound medicines, and published by ...

(compendium of

drug A drug is any chemical substance that causes a change in an organism's physiology or psychology when consumed. Drugs are typically distinguished from food and substances that provide nutritional support. Consumption of drugs can be via insuffla ...

information) for the

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published annually by the United States Pharmacopeial Convention (usually also called the USP), a nonprofit organization that owns the

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and also owns the

copyright A copyright is a type of intellectual property that gives its owner the exclusive right to copy, distribute, adapt, display, and perform a creative work, usually for a limited time. The creative work may be in a literary, artistic, education ...

on the pharmacopeia itself. The ''USP'' is published in a combined volume with the ''National Formulary'' (a formulary) as the USP-NF. If a drug ingredient or drug product has an applicable ''USP'' quality standard (in the form of a ''USP-NF'' monograph), it must conform in order to use the designation "USP" or "NF". Drugs subject to ''USP'' standards include both human drugs ( prescription,

over-the-counter Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional, as opposed to prescription drugs, which may be supplied only to consumers possessing a valid prescr ...

, or otherwise) and animal drugs. ''USP-NF'' standards also have a role in

US federal law The law of the United States comprises many levels of codified and uncodified forms of law, of which the most important is the nation's Constitution, which prescribes the foundation of the federal government of the United States, as well as v ...

; a drug or drug ingredient with a name recognized in ''USP-NF'' is considered adulterated if it does not satisfy compendial standards for strength, quality or purity. USP also sets standards for dietary supplements and food ingredients (as part of the ''

Food Chemicals Codex The Food Chemicals Codex (FCC) is a collection of internationally recognized standards for the purity and identity of food ingredients. Scope The FCC features more than 1,250 monographs, including food-grade chemicals, processing aids, foods (suc ...

''). USP has no role in enforcing its standards; enforcement is the responsibility of the U.S.

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...

(FDA) and other government authorities in the United States.

Product quality–standards and verification

''USP'' establishes written (documentary) and physical (

reference Reference is a relationship between objects in which one object designates, or acts as a means by which to connect to or link to, another object. The first object in this relation is said to ''refer to'' the second object. It is called a '' name'' ...

) 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.

USP 800 USP may refer to: Government institutions * '' Unité Spéciale de la Police'', Luxembourg * United States Penitentiary, a prison * Utah State Prison, Draper, US Math and science * Ultra-short period planets, orbiting planets with periods sh ...

is an example of a publication created by the United States Pharmacopeia. Prescription and over-the-counter medicines available in the United States must, by

federal law Federal law is the body of law created by the federal government of a country. A federal government is formed when a group of political units, such as states or provinces join in a federation, delegating their individual sovereignty and many po ...

, 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 ''

'' (''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

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and

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, it currently does not have statutory recognition in the United States, although ''FCC'' standards are incorporated by reference in over 200 FDA food regulations. USP obtained the ''FCC'' from the

Institute of Medicine The National Academy of Medicine (NAM), formerly called the Institute of Medicine (IoM) until 2015, is an American nonprofit, non-governmental organization. The National Academy of Medicine is a part of the National Academies of Sciences, E ...

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.

Healthcare information

In the past, Congress authorized the Secretary of HHS to request USP to develop a drug classification system that Medicare Prescription Drug Benefit plans may use to develop their formularies, and to revise such classification from time to time to reflect changes in therapeutic uses covered by Part D drugs and the addition of new covered Part D drugs. USP has developed six versions of the Model Guidelines, the last issued early in 2014 for the 2015–2017 benefit years.

Promoting the Quality of Medicines program

Since 1992, USP has worked cooperatively with the

United States Agency for International Development The United States Agency for International Development (USAID) is an independent agency of the U.S. federal government that is primarily responsible for administering civilian foreign aid and development assistance. With a budget of over $27 bi ...

(USAID) to help developing countries address critical issues related to poor quality medicines. This partnership operated as the Drug Quality and Information (DQI) program until 2009, when, to better meet growing global needs, USAID awarded USP a five-year, $35 million cooperative agreement to establish a new, expanded program
Promoting the Quality of Medicines (PQM)
In 2013 USAID extended the PQM program for five years (through September 2019), increased its funding to $110 million, and expanded the geographical reach of the program. PQM serves as a primary mechanism to help USAID-supported countries strengthen their quality assurance and quality control systems to better ensure the quality of medicines that reach patients. PQM has four key objectives: * Strengthen quality assurance (QA) and quality control (QC) systems * Increase the supply of quality assured medicines * Combat the availability of substandard and counterfeit medicines * Provide technical leadership and global advocacy USP-USAID collaborative efforts have helped communities improve drug quality in more than 35 countries. PQM currently works i
AfricaAsiaEurope/Eurasia
and th
Caribbean/Latin America

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 Pharmacopeia of the People's Republic of China Chinese Pharmacopeia 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).Федеральная служба по надзору в сфере здравоохранения
/ref> USP also operates an international office in Switzerland and offices and laboratories in Brazil, India, and China.

References

External links