United State Pharmacopoeia

United State Pharmacopoeia

The United States Pharmacopoeia and National Formulary (USP-NF) is an official public standards-setting authority for all prescription and over–the–counter medicines and other healthcare products manufactured or sold in the United States. 

USP also sets recognized standards for food ingredients and dietary supplements. These standards help to ensure the quality, purity, strength, and consistency of products made for public consumption.  USP's standards are recognized and used in more than 130 countries around the globe. 

USP's work is aided by the participation and oversight of volunteers representing pharmacy,  medicine, other healthcare professions, academia, government, the pharmaceutical and food industries, health plans, and consumer organizations. 

The United States Pharmacopoeia was initially published in 1820 under the authority of the United States Pharmacopoeial Convention. The National Formulary was published in 1888 under the guidance of the American Pharmaceutical Association.


In 1974 the National Formulary was purchased by the United States Pharmacopoeial  Convention and from 1980 onwards only one official book of drug standards was published under the heading, The United States Pharmacopoeia and The National Formulary  (USP-NF). 

The United States Pharmacopoeia–National Formulary (USP–NF) 2009 is a book of public pharmacopoeial standards.

It contains standards for medicines, dosage forms, drug substances, excipients, medical devices, and dietary supplements. 

USP–NF in English is available in print, online, and CD formats. 

The USP–NF is a three-volume combination of two official compendia, the United States.


Pharmacopoeia (USP) and the National Formulary (NF) 

Monographs for drug substances and preparations are featured in the USP. 

Monographs for dietary supplements and ingredients appear in a separate section of the  USP. 

Excipient monographs are in the NF. 

A monograph includes the name of the ingredient or preparation; the definition;  packaging, storage, and labelling requirements; and the specification. 

The specification consists of a series of tests, procedures for the tests, and acceptance criteria. These tests and procedures require the use of official USP Reference Standards.


Medicinal ingredients and products will have the stipulated strength, quality, and purity if they conform to the requirements of the monograph and relevant general chapters. 

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