Ежегодный справочник лекарственных средств США (USP)

Annual drug compendium
a compendium of drug information

The United States Pharmacopeia (USP) is a pharmacopeia (compendium of drug information) for the United States published annually by the over 200 year old United States Pharmacopeial Convention (usually also called the USP), a nonprofit organization that owns the trademark and also owns the copyright 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, or otherwise) and animal drugs. USP NF standards also have a role in US federal law; 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). USP has no role in enforcing its standards; enforcement is the responsibility of the U. S. Food and Drug Administration (FDA) and other government authorities in the United States.

The U. S. Pharmacopeia (USP) was formed in 1820 when 11 physicians came together to take action to protect patients from being harmed by the inconsistent and poor quality medical preparations at that time. The first standards were "recipes" that guided the preparation of medicines, which were often manufactured in apothecaries relying heavily on crude botanical drugs having therapeutic activities. When the modern pharmaceutical industry emerged, USP standards changed from those "recipes" to a set of quality specifications for medicines along with analytical tests to be performed to assess their purity, quality, and authenticity. 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.

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.

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). USP also operates an international office in Switzerland and offices and laboratories in Brazil, India, and China.