United States Pharmacopeia and National Formulary

The USP was combined as a compendium with the National Formulary (NF) in 1975. Currently, the USP gives information regarding substances considered as having active medicinal properties while pharmaceutically inactive necessities are described in NF. The combined United States Pharmacopeia and National Formulary (USP-NF) is legally recognized under the U.S. Federal Food, Drug and Cosmetic Act. 

General standards for drugs are typically published in the so-called national pharmacopoeia. The names of the different national pharmacopoeia are formed by pharmacop(o)eia combined with the name of the country, for example, the United States Pharmacopeia and National Formulary (USP-NF). Attempts to generalize and unify the different national pharmacopoeia have continued for over a century. The European Community signed a convention that resulted in issuance of the European Pharmacopoeia [11 ]. Finally, the WHO (United Nations World Health Organization) publishes a Pharmacopoeia Internationalis [12]. 

United States Pharmacopeia and National Formulary (USP-NF) are frequently cited in an NDA and considered during the chemistry review. 

Pharmacopeial Standards United States Pharmacopeia and National Formulary... 

The USP Convention is the publisher of the United States Pharmacopeia and National Formulary (USPINF). These texts and supplements are recognized as official compendia under the Federal Food, Drug Cosmetic Act (FD C Act). As such, their standards of strength, quality, purity, packaging, and labeling are directly enforceable under the adulteration and misbranding provisions without further approval or adoption by the FDA (http //www.usp.org frameset.htm http //www. usp,org/standards/fda/jgv testimony.htm). 

UNITED STATES PHARMACOPEIA AND NATIONAL FORMULARY CHROMATOGRAPHIC METHODS... 

REGENT CHEMICALS American Chemical Society Specifications, American Chemical Society, Washington, DC. For suggestions on the testing of reagents not listed by the American Chemical Society, Analar Standards for Laboratory Chemicals, BDH Ltd., Poole, Dorset, U.K., and the United States Pharmacopeia and National Formulary, U.S. Pharmacopeial Convention, Inc. (USPC), Rockville, MD. 

---