Compounding Sterile Preparations, Third Edition
Empower your staff to improve safety, quality and compliance with the help of new guidelines and standards. We’ve updated every chapter of this popular review of the fundamentals of preparing sterile products in hospital, home-care, and community pharmacy settings to reflect the most recent revisions to USP <797>.\ Included are the latest guidelines for the compounding process, quality assurance methods, and comprehensive coverage of all aspects of the dispensing process. Comprehensive...
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Table of Contents\ Dedication.............................................................................................................................iii\ Preface..................................................................................................................................v\ Contributors...........................................................................................................................xi\ Section I: Sterile Preparation\ 1. Standards for Sterile Preparations................................................................................... 1\ E. Clyde Buchanan\ 2. Sterile Preparation Formulation.......................................................................................19\ E. Clyde Buchanan\ 3. Ancillary Equipment and Supplies................................................................................. 33\ E. Clyde Buchanan\ 4. Primary Engineering Controls.........................................................................................43\ James T. Wagner\ 5. Personnel Cleansing and Garbing..................................................................................61\ E. Clyde Buchanan\ 6. Aseptic Technique..........................................................................................................69\ Philip J. Schneider\ 7. Hazardous Drugs as Compounded Sterile Preparations...............................................79\ Luci A. Power\ 8. Radiopharmaceuticals as Compounded Sterile Preparations..................................... 99\ George H. Hinkle\ 9. Allergen Extracts as Compounded Sterile Preparations..............................................109\ Lina Lattouf\ 10. Storage and Beyond-Use Dating.................................................................................115\ Caryn M. Bing\ 11. Labeling Sterile Preparations.......................................................................................129\ Patricia J. Kuban\ 12. Documentation of Compounded Sterile Preparations................................................ 143\ E. Clyde Buchanan\ 13. Verification of Compounding Accuracy and Sterility................................................... 149\ Eric S. Kastango\ 14. Finished Preparation Release Checks and Tests........................................................159\ Eric S. Kastango\ 15. Handling Sterile Commercial Products and Compounded Sterile Preparations Within\ the Pharmacy................................................................................................................ 171\ E. Clyde Buchanan\ 16. Maintaining Sterility, Purity, and Stability of Dispensed and Distributed CSPs......... 183\ Caryn M. Bing\ 17. Batch Compounding.................................................................................................. 191\ E. Clyde Buchanan\ Section II: Quality Management\ 18. Gap Analyses and Action Plans................................................................................. 201\ E. Clyde Buchanan\ 19. Pharmacist Education..................................................................................................241\ Philip J. Schneider\ 20. Pharmacy Technician Education, Certification, Training, Evaluation,\ and Regulation.............................................................................................................. 249\ E. Clyde Buchanan\ 21. Secondary Engineering Controls.................................................................................259\ E. Clyde Buchanan\ 22. Safe Use of Automated Compounding Devices..........................................................281\ Jay M. Mirtallo and Philip J. Schneider\ 23. Cleaning and Disinfecting.............................................................................................289\ E. Clyde Buchanan\ 24. Environmental Quality and Control...............................................................................303\ Eric S. Kastango\ 25. Dealing with Latex Allergies..........................................................................................317\ Stephen K. Hetey\ 26. Personnel Training and Competency Evaluation of Garbing and\ Aseptic Work Practices................................................................................................. 325\ Eric S. Kastango\ 27. Policies, Procedures, and Quality Assurance Programs............................................. 337\ E. Clyde Buchanan\ 28. Outsourcing the Compounding of Sterile Preparations............................................... 355\ E. Clyde Buchanan\ Section III: Appendixes\ A. ASHP Guidelines on Pharmacy-Prepared Ophthalmic Products....................................367\ B. ASHP Guidelines on the Safe Use of Automated Compounding Devices for the\ Preparation of Parenteral Nutrition Admixtures................................................................ 371\ C. ASHP Guidelines on Handling Hazardous Drugs........................................................ 379\ D. CETA Applications Guide for the Use of Compounding Aseptic Isolators in\ Compounding Sterile Preparations in Healthcare Facilities\ CAG-001-2005 (12/8/2008)................................................................................................ 409\ E. CETA Compounding Isolator Testing Guide CAG-002-2006 (12/8/2008)..................... 419\ F. CETA Certification Guide for Sterile Compounding Facilities\ CAG-003-2006 (12/8/2008)................................................................................................ 437\ G. FDA Compliance Policy Guide...................................................................................... 443\ H. Guidance for FDA Staff and Industry Compliance Policy Guides Manual Sec. 460.200\ Pharmacy Compounding................................................................................................... 447\ I. Model Rules for Sterile Pharmaceuticals......................................................................... 453\ J. The National Institute for Occupational Safety and Health (NIOSH) Alert—\ Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs\ in Health Care Settings........................................................................................................ 459\ K. The American Society for Parenteral and Enteral Nutrition document Safe Practices\ for Parenteral Nutrition......................................................................................................... 461\ Glossary............................................................................................................................... 463\ Index .................................................................................................................................... 477\ \
\ From The CriticsReviewer: Nancy M Makem, Pharm D(Nazareth Hospital)\ Description: This third edition of a reference detailing all of the requirements for compounding includes important updates to the USP 797 guidelines.\ Purpose: It is intended to be used in order to help improve compliance and understanding of the USP 797 guidelines. The guidelines have been revised (and finalized) and many states are now requiring that these guidelines be followed. \ Audience: According to the author, the book is intended for use in colleges of pharmacy, pharmacy departments, and pharmacy technician training programs. It is a valuable resource, especially for any director of pharmacy or IV room coordinator who is preparing to open a new clean room. \ Features: This book covers all of the 797 requirements, as well as how to comply with the requirements and resources available for doing so. I found the section on hand hygiene and garbing particularly helpful as our IV room has been open less than two months. This was a great review to ensure that we are, indeed, compliant. The reference section is excellent and contains all of the needed guidelines for hazardous drugs and CETA certifications. I would have liked to have seen the USP 797 final revision included in the reference section. \ Assessment: This an excellent book to have on hand in any operational IV room and a definite must have for any pharmacy that is preparing to open a USP 797 compliant IV room. This third edition is needed now that the final revision of USP 797 guidelines has been published.\ \
