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.