United States Pharmacopeia
Encyclopedia
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 supplement
s.
) 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 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.
, 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.
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.
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
, 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
Prescription drug
A prescription medication is a licensed medicine that is regulated by legislation to require a medical prescription before it can be obtained. The term is used to distinguish it from over-the-counter drugs which can be obtained without a prescription...
and over–the–counter
Over-the-counter drug
Over-the-counter drugs are medicines that may be sold directly to a consumer without a prescription from a healthcare professional, as compared to prescription drugs, which may be sold only to consumers possessing a valid prescription...
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 supplement
Dietary supplement
A dietary supplement, also known as food supplement or nutritional supplement, is a preparation intended to supplement the diet and provide nutrients, such as vitamins, minerals, fiber, fatty acids, or amino acids, that may be missing or may not be consumed in sufficient quantities in a person's diet...
s.
Product quality–standards and verification
USP establishes written (documentary) and physical (referenceReference standard
A drug reference standard is a standardized substance which is used as a measurement base for similar substances. Where the exact active substances of a new drug are not known, a reference standard provides a calibrated level of biological effects against which new preparations of the drug can be...
) 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
United States Code
The Code of Laws of the United States of America is a compilation and codification of the general and permanent federal laws of the United States...
, 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
Australia
Australia , officially the Commonwealth of Australia, is a country in the Southern Hemisphere comprising the mainland of the Australian continent, the island of Tasmania, and numerous smaller islands in the Indian and Pacific Oceans. It is the world's sixth-largest country by total area...
, Canada
Canada
Canada is a North American country consisting of ten provinces and three territories. Located in the northern part of the continent, it extends from the Atlantic Ocean in the east to the Pacific Ocean in the west, and northward into the Arctic Ocean...
and New Zealand
New Zealand
New Zealand is an island country in the south-western Pacific Ocean comprising two main landmasses and numerous smaller islands. The country is situated some east of Australia across the Tasman Sea, and roughly south of the Pacific island nations of New Caledonia, Fiji, and Tonga...
, it currently does not have broad legal recognition in the United States. USP obtained the FCC from the Institute of Medicine
Institute of Medicine
The Institute of Medicine is a not-for-profit, non-governmental American organization founded in 1970, under the congressional charter of the National Academy of Sciences...
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
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 formulariesFormulary (pharmacy)
At its most basic level, a formulary is a list of medicines. Traditionally, a formulary contained a collection of formulas for the compounding and testing of medication . The main function of formularies today is to specify which medicines are approved to be prescribed under a particular contract...
. 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)United States Agency for International Development
The United States Agency for International Development is the United States federal government agency primarily responsible for administering civilian foreign aid. President John F. Kennedy created USAID in 1961 by executive order to implement development assistance programs in the areas...
, 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)Memorandum of understanding
A memorandum of understanding is a document describing a bilateral or multilateral agreement between parties. It expresses a convergence of will between the parties, indicating an intended common line of action. It is often used in cases where parties either do not imply a legal commitment or in...
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.
See also
- Food and Drug AdministrationFood and Drug AdministrationThe Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
- MedlinePlusMedlinePlusMedlinePlus is a free Web site that provides consumer health information for patients, families, and Health care providers. The site brings together information from the United States National Library of Medicine, the National Institutes of Health , other U.S. government agencies, and...
, for information of specific drugs - National Formulary
- PharmacopoeiaPharmacopoeiaPharmacopoeia, pharmacopeia, or pharmacopoea, , in its modern technical sense, is a book containing directions for the identification of samples and the preparation of compound medicines, and published by the authority of a government or a medical or pharmaceutical society.In a broader sense it is...
- The International PharmacopoeiaThe International PharmacopoeiaThe aim of The International Pharmacopoeia , which is issued by the World Health Organization as a recommendation, is to achieve a wide global uniformity of quality specifications for selected pharmaceutical products, excipients, and dosage forms.The information published in The International...
- European PharmacopoeiaEuropean PharmacopoeiaThe European Pharmacopoeia of the Council of Europe is a pharmacopoeia, listing a wide range of active substances and excipients used to prepare pharmaceutical products in Europe...
- Pill splitting, for a discussion of USP standards concerning uniformity of dosage