United States Pharmacopeia
| Nonprofit | |
| Founded | 1820 |
| Headquarters | Rockville, Maryland, USA |
|
Key people
|
Ronald T. Piervincenzi, Chief Executive Officer |
| Website | www |
The United States Pharmacopoeia (USP) is a pharmacopoeia (compendium of drug information) for the United States published annually by the United States Pharmacopoeial Convention (usually also called the USP), a nonprofit organization that owns the trademark and copyright. 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, or otherwise), as well as animal drugs. USP-NF standards also have a role in U.S. federal law; a drug or drug ingredient with a name recognized in USP-NF is deemed 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). USP has no role in enforcing its standards; enforcement is the responsibility of FDA and other government authorities in the U.S. and elsewhere.
USP establishes written (documentary) and physical (reference) 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 pharmacopoeia, or to supplement their government pharmacopoeia.
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 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 in 2006. The IOM had published the first five editions of the FCC.
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