United States Pharmacopeia and The National Formulary

U.S. PHARMACOPEIA (USP) A non-profit organization that provides standards for prescription and over-the-counter drugs, nutritional and dietary supplements, and health care products. USP publishes its standards in the United States Pharmacopeia and the National Formulary (USP-NF), which are officially recognized by the U.S. Food and Drug Administration (FDA). USP also has a dietary supplement verification program (DSVP). 

Suspensions Heterogeneous systems containing coarsely dispersed material that settles. A wide variety of pharmaceutical preparations have been used as suspensions, for example. White Lotion, Magma of Bismuth, and Compound Mixture of Opium and Glycyrrhiza (Brown Mixture). In addition, several official ointments are suspensions of solids in a semisolid base. A large number of suspensions are categorized as mixtures in the United States Pharmacopeia and the National Formulary ... 

Schniepp, SJ, (2006) Understanding the united states pharmacopeia and the national formulary demystifying the standards-setting process. Davis Healthcare International Publishing, Moore, OK. 

Anonymous (2012) <729> Globule size distributirai in lipid injectable emulsions. In The United States Pharmacopeia and the national formulary, 36th edn. United States Pharmacopeial Convention, Rockville... 

Tanno F, Nishiyama Y, Kokubo H, Obara S (2004) Evaluation of hypromeUose acetate succinate (HPMCAS) as carrier in solid dispersions. Drug Dev Ind Pharm 30 9-17 Torrado S, Torrado S, Torrado JJ, Cadomiga R (1996) Preparation, dissolution and characterization of albendazole solid dispersions. Int J Pharm 140 247-250 USP (2009a) The United States pharmacopeia and the national formulary, <711 > Dissolution. The Official Compendia of Standards USP 32-NF 27... 

Pharmaceutical or chemical equivalence means that two or more drug products contain equal amounts of the same therapeutically active ingre-dient(s) in identical dosage forms, and that these dosage forms meet the requirements such as purity, content uniformity and disintegration time as established by the United States Pharmacopeia and/ or 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]. 

The United States Pharmacopeia, 22nd rev. 1990, and The National Formulary, 17th ed., Rockville, Md., 1990. These are published together as one volume. 

Aspartame is a compendial article, whose specifications and test methods are listed in the National Formulary of the United States Pharmacopeia [19]. The described program of testing and qualification is described in the following sections. 

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

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). 

The United States Pharmacopeia, 27 rev., and the National Formulary. 22nd ed. USP General Information Chapter. Pharmaceutical Compounding—Sterile Preparations. Rockville, MD The United States Pharmacopeia Convention, 2003. www.usp.org. Accessed December 15, 2006. 

Drug (medical) Articles recognized in the official United States Pharmacopeia, of the United States, or official National Formulary, and (b) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals and (c) articles (other than food) intended to affect the structure or any function of the body of man or other animals and (d) articles intended for use as a component of any articles specified in clause (a), (b), or (c) but does not include devices or their components, parts, or accessories. 

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. 

The Pharmacopeia of the United States of America, 32nd Revision and The National Formulary, 27th Ed. (General Notices and Requirements), pp. 1-12, 2009. 

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