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Return to Newsletter WHAT'S NEXT FOR USP <797>? From its introduction in January 2004, USP Chapter <797> has generated discussion and controversy. At the December 2005 ASHP, Baxa Corporation sponsored speaker Eric Kastango to discuss the current state of the guidelines, proposed changes to USP <797> and their impact on pharmacy remediation plans for USP 797. The program also included discussion on state boards of pharmacy’s responses to USP Chapter <797> and ways to address the areas of non-compliance identified by the gap analyses already performed by pharmacies. DEFINING CSPs UNDER USP 797 Sterile compounding, under the USP definition, pertains to all pre-administration manipulations of compounded sterile products (CSPs), including compounding, storage, and transport, but not their administration to patients. Sterile compounding differs from non-sterile compounding primarily by requiring the maintenance of sterility when compounding exclusively with sterile ingredients and components, and the achievement of sterility when compounding with non-sterile ingredients and components. USP 797 GUIDELINES – A MOVING TARGET? Many pharmacists have expressed frustration at their impression that the guidelines for USP 797 compliance are a ‘moving target.’ Since January 2004, there have been no published changes released to the original guidelines. The confusion may result from the fact that healthcare professionals have submitted comments and recommendations for changes and these have been much-discussed in trade journals and Web publications. The Sterile Compounding Committee (SCC) has met and reviewed recommendations, developing proposed changes to USP Chapter. USP contacted more than 100 organizations or stakeholders to ensure their respective members were made aware of the proposed changes prior to their draft publication. The revised guidelines have been published in the May-June 2006 Pharmacopeial Forum (PF), with a 90-day comment period. The next USP Chapter <797> with the changes will be effective in USP 30-NF 25 (January 2007). The SCC welcomes comments, so make your voice heard! Visit the USP Web site to review the proposed changes. Or, contact Claudia Okeke, PhD – USP liaison – at cco@usp.org. PROPOSED CHANGES TO THE GUIDELINES For a complete copy of the new draft guidelines check the USP Web site at http://www.usp.org/USPNF/pf/generalChapter797.html. Send any comments to www.usp.org/USPNF/pf/797comments.html. PROPRIETARY BAG AND VIAL SYSTEMS The storage and beyond use times for attached and activated (closures punctured allowing contact of contents) of proprietary packaging systems of drug products for IV administration (e.g., ADD-Vantage® and Mini-Bag Plus®) are those stated in the FDA-approved labeling of their respective manufacturers. CATEGORIES OF CSPs Immediate Use. Six qualifications have been outlined to define immediate use. Three or fewer sterile products may be prepared in worse than ISO Class 5 air when there is no direct contact contamination and administration begins within 1 hour. No hazardous drug can fall into this category. Low Risk. No significant changes. Safety. Designed for oral liquid delivery ONLY. The specialty tip of the oral dispenser will not accept an IV needle, virtually eliminating the risk of accidental injection of oral medications Medium Risk. Refrigerated storage is being changed to 9 days. The extension from 7 days was granted after request from home infusion pharmacists who ship refrigerated TPN. This is the only proposed revision that is not based on increasing patient safety by either standards or clarifying text. High-Risk. Added qualifications regarding use of sterile ingredients without preservatives and the exposure of sterile devices to air quality worse than ISO Class 5. An anteroom or ante area is an environment that is supplied with HEPA- filtered air that meets ISO Class 8 air cleanliness. DATING AND TESTING USP <51> Antimicrobial Effectiveness Testing requires no testing beyond 28 days, and USP chapters, i.e., <797>, must refer to other USP chapters, i.e., <51>, when possible. HAZARDOUS DRUG HANDLING Copies of Baxa Corporation technical reports on USP 797 requirements and |
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