Rockville, Md., January 03, 2006—The United States Pharmacopeia (USP) is pleased to announce that the new edition of the United States Pharmacopeia and National Formulary (USP–NF) is official, effective January 1, 2006. It will be followed by two Supplements in February (official on April 1, 2006) and June (official on August 1, 2006).
This edition of USP–NF contains several new features and revisions, including more than 88 new monographs (including dietary supplements), and 404 revised monographs. A total of 11 new/revised general chapters will affect practices for both pharmacists and pharmaceutical manufacturers.
The new chapters are:
<345> Assay for Citric Acid/Citrate and Phosphate
<1065> Ion Chromatography
The revised chapters are:
<11> USP Reference Standards
<341> Antimicrobial Agents–Content
<841> Specific Gravity
<851> Spectrophotometry and Light-Scattering
<1075> Good Compounding Practices
<1119> Near-Infrared Spectrophotometry
<2023> Microbiological Attributes of Nonsterile Nutritional and Dietary Supplements
A new option is now available for the online format, “My USP–NF,” which allows customized searches and bookmarks. USP–NF is also available in an official Spanish print edition.
USP–NF is the consolidation of two separate official compendia—USP and NF— to form one comprehensive resource. USP contains legally recognized standards of identity, strength, quality, purity, packaging, and labeling for drug substances, dosage forms, and other therapeutic products. The National Formulary (NF) contains standards for products such as excipients.
USP–NF monographs contain specifications (tests, procedures, and acceptance criteria) that help ensure the strength, quality, and purity of named items. USP–NF also contains monographs and general approaches to ensure the quality of compounded preparations. USP–NF monographs, which are recognized worldwide, may be enforceable by the U.S. Food and Drug Administration (FDA) and also by state agencies in the United States.
The new USP 29–NF 24 is available in print, CD, and online formats. For more information or to order USP–NF, please call 1-800-227-8772, or visit the USP Web site at www.usp.org. The USP 29–NF 24, Spanish version is available only in print. Customer service hours have also been extended, and USP now offers multilingual support.
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USP—Advancing Public Health Since 1820
The United States Pharmacopeia (USP) is a nonprofit, nongovernmental, standards-setting organization that advances public health and improves patient safety by ensuring good pharmaceutical care. USP standards, which are recognized worldwide, are developed through a unique process of public involvement by volunteers representing pharmacy, medicine, and other healthcare professions, as well as science, academia, government, the pharmaceutical industry, and consumer organizations. For more information about USP and its standards-setting activities, visit http://www.usp.org/aboutUSP/media.