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USP 27- NF 22 Becomes Official - Third Annual Edition Contains New Requirements

Tue, 02/17/2004 - 8:53am
The United States Pharmacopeia (USP) recently announce that its official standards publication, the United States Pharmacopeia 27 and National Formulary 22 (USP 27-NF 22) became official on Jan. 1, 2004. Two Supplements will follow in February and June-becoming official in April and August 2004, respectively.

This edition of the USP-NF contains several new features and revisions, including six new general chapters that will affect practices for both pharmacists and pharmaceutical manufacturers. The new chapters are:

• Good Compounding Practices• Pharmaceutical Calculations in Prescription Compounding
• Pharmaceutical Compounding - Sterile Preparations
• Monitoring Devices - Time, Temperature, and Humidity
• Pharmacopeial Harmonization
• Crystallinity Determination by Solution Calorimetry

Along with the new chapters are 20 revised general chapters, more than 70 new monographs and 340 revised monographs. Also included in the USP 27-NF 22 is a newly created section on dietary supplements. The dietary supplement section contains 200 monographs for vitamin-mineral combination products, botanicals and nonbotanicals used in almost 900 dietary supplements. Another updated feature is improved charts to help readers better navigate through the general chapters. A revised table of contents and index also will increase usability for readers.

The USP-NF is the consolidation of two separate official compendia-the USP and the NF- to form one comprehensive resource. The 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. The 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 27-NF 22 is available in print, CD and online formats. For more information or to order the USP-NF, please call 1-800-227-8772, or visit the USP Web site at www.usp.org.

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