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Abstract
The essential sterile compounding reference every pharmacist needs – now with important updates.
Compounding Sterile Preparations, Fourth Edition, by E. Clyde Buchanan, Philip J. Schneider, and Ryan A. Forrey, is the most comprehensive and authoritative reference available on sterile compounding. It’s a trusted resource that every pharmacist needs.
The newest edition of this publication now includes:
Compounding Sterile Preparations, Fourth Edition, by E. Clyde Buchanan, Philip J. Schneider, and Ryan A. Forrey, is the most comprehensive and authoritative reference available on sterile compounding. It’s a trusted resource that every pharmacist needs.
The newest edition of this publication now includes:
- Coverage of new USP Chapter <800> on the compounding of hazardous drugs and the existing USP Chapter <797>
- Updates on regulations related to the Drug Quality and Security Act (DQSA)
- Seven new chapters and 16 new contributors
- Appendices offering more extensive reference to online resources
E. Clyde Buchanan, MS, RPh, FASHP
E. Clyde Buchanan is a pharmacy consultant and recognized expert on compounding sterile preparations and pharmacy planning, budgeting and operations. He is retired from Emory Healthcare in Atlanta where he was Senior Director of Pharmaceutical Services. Mr. Buchanan received his B.S. in Pharmacy from the University of North Carolina and M.S. and residency training from The Ohio State University. Prior to Emory, he held pharmacy leadership positions at Duke University Medical Center and St. John’s Hospital in Springfield IL. Mr. Buchanan has served the American Society of Health-System Pharmacists (ASHP) as Chairman of SIG on Administrative Practice; Vice Chair of the Council on Legal and Public Affairs; member of the House of Delegates, several committees, and task forces. Mr. Buchanan has edited and authored four books on sterile compounding and numerous manuscripts and book chapters. He has been a frequent speaker for state and national conferences on USP Chapter <797>.
Philip J. Schneider, MS, FASHP
Philip J. Schneider is Clinical Professor and Associate Dean for Academic and Professional Affairs for the University of Arizona, College of Pharmacy at the Phoenix Biomedical campus. In this position, he provides oversight, development, and administration of educational initiatives including teaching, service and scholarship activities at the newly created Phoenix Biomedical Campus.
He received a B.S. in Pharmacy from the University of Wisconsin, and M.S. in Hospital Pharmacy from The Ohio State University and received a Certificate of Residency from The Ohio State University Hospitals. During his 47 years of professional and academic service, he has published more than 170 articles and abstracts in professional and scientific journals, 38 book chapters, edited 7 books, and given more than 500 contributed or invited presentations in 22 countries and the United States.
Ryan A. Forrey, PharmD, MS, FASHP
Ryan A. Forrey is currently Senior Manager, Market Development for Becton Dickinson and Company (BD) focused on the hazardous drug safety platform for the company and is a Clinical Assistant Professor at The Ohio State University College of Pharmacy. Prior to his transition to BD, he was Director of Pharmacy at Emory University Hospital Midtown in Atlanta where he was responsible for the distributive and clinical operations for the inpatient facility as well as the Winship Cancer Institute infusion center pharmacies. He currently serves on the United States Pharmacopeial Convention (USP) Compounding Expert Committee, the group charged with creating compounding standards for sterile, nonsterile, and hazardous drugs. He also served in a leadership role as Associate Director of Pharmacy at The Ohio State University James Cancer Hospital in Columbus, Ohio, where he oversaw design and construction of new and highly-automated cancer hospital inpatient pharmacy as well as several outpatient infusion center pharmacies.
He received his Doctor of Pharmacy from the University of Arizona, and M.S. in Health-System Pharmacy Administration from The Ohio State University and completed a combined PGY1/PGY2 Residency in Health-System Pharmacy Administration from The Ohio State University Wexner Medical Center. He provides graduate course lectures at The Ohio State University College of Pharmacy on the topics of pharmacy management and sterile compounding facility design. He is a prolific speaker on the topics of sterile compounding facility design, USP Chapter <797>, USP Chapter <800>, and oncology pharmacy operations.
E. Clyde Buchanan is a pharmacy consultant and recognized expert on compounding sterile preparations and pharmacy planning, budgeting and operations. He is retired from Emory Healthcare in Atlanta where he was Senior Director of Pharmaceutical Services. Mr. Buchanan received his B.S. in Pharmacy from the University of North Carolina and M.S. and residency training from The Ohio State University. Prior to Emory, he held pharmacy leadership positions at Duke University Medical Center and St. John’s Hospital in Springfield IL. Mr. Buchanan has served the American Society of Health-System Pharmacists (ASHP) as Chairman of SIG on Administrative Practice; Vice Chair of the Council on Legal and Public Affairs; member of the House of Delegates, several committees, and task forces. Mr. Buchanan has edited and authored four books on sterile compounding and numerous manuscripts and book chapters. He has been a frequent speaker for state and national conferences on USP Chapter <797>.
Philip J. Schneider, MS, FASHP
Philip J. Schneider is Clinical Professor and Associate Dean for Academic and Professional Affairs for the University of Arizona, College of Pharmacy at the Phoenix Biomedical campus. In this position, he provides oversight, development, and administration of educational initiatives including teaching, service and scholarship activities at the newly created Phoenix Biomedical Campus.
He received a B.S. in Pharmacy from the University of Wisconsin, and M.S. in Hospital Pharmacy from The Ohio State University and received a Certificate of Residency from The Ohio State University Hospitals. During his 47 years of professional and academic service, he has published more than 170 articles and abstracts in professional and scientific journals, 38 book chapters, edited 7 books, and given more than 500 contributed or invited presentations in 22 countries and the United States.
Ryan A. Forrey, PharmD, MS, FASHP
Ryan A. Forrey is currently Senior Manager, Market Development for Becton Dickinson and Company (BD) focused on the hazardous drug safety platform for the company and is a Clinical Assistant Professor at The Ohio State University College of Pharmacy. Prior to his transition to BD, he was Director of Pharmacy at Emory University Hospital Midtown in Atlanta where he was responsible for the distributive and clinical operations for the inpatient facility as well as the Winship Cancer Institute infusion center pharmacies. He currently serves on the United States Pharmacopeial Convention (USP) Compounding Expert Committee, the group charged with creating compounding standards for sterile, nonsterile, and hazardous drugs. He also served in a leadership role as Associate Director of Pharmacy at The Ohio State University James Cancer Hospital in Columbus, Ohio, where he oversaw design and construction of new and highly-automated cancer hospital inpatient pharmacy as well as several outpatient infusion center pharmacies.
He received his Doctor of Pharmacy from the University of Arizona, and M.S. in Health-System Pharmacy Administration from The Ohio State University and completed a combined PGY1/PGY2 Residency in Health-System Pharmacy Administration from The Ohio State University Wexner Medical Center. He provides graduate course lectures at The Ohio State University College of Pharmacy on the topics of pharmacy management and sterile compounding facility design. He is a prolific speaker on the topics of sterile compounding facility design, USP Chapter <797>, USP Chapter <800>, and oncology pharmacy operations.
Table of Contents
| Section Title | Page | Action | Price |
|---|---|---|---|
| Table of Contents | 5 | ||
| Acknowledgments | 9 | ||
| Preface | 11 | ||
| Contributors | 13 | ||
| Reviewer | 15 | ||
| Part I: Sterile Preparation | 17 | ||
| Ch 01 Imperative for Change: Adverse SterileCompounding Events | 19 | ||
| Ch 02 Standards for Compounded Sterile Preparations | 25 | ||
| Ch 03 Immediate-Use Compounding | 53 | ||
| Ch 04 Sterile Preparation Formulation | 69 | ||
| Ch 05 Parenteral Nutrition Compounding | 85 | ||
| Ch 06 Special Considerations in Pediatric Compounding | 99 | ||
| Ch 07 Special Considerations in Compounding Biologicals | 131 | ||
| Ch 08 Ancillary Equipment and Supplies | 139 | ||
| Ch 09 Primary Engineering Controls | 151 | ||
| Ch 10 Personnel Cleansing and Garbing | 171 | ||
| Ch 11 Aseptic Technique | 179 | ||
| Ch 12 Hazardous Drugs as Compounded Sterile Preparations | 189 | ||
| Ch 13 Radiopharmaceuticals as Compounded Sterile Preparations | 221 | ||
| Ch 14 Storage and Beyond-Use Dating | 231 | ||
| Ch 15 Labeling Sterile Preparations | 245 | ||
| Ch 16 Documentation of Compounded Sterile Preparations | 261 | ||
| Ch 17 Sterility Assurance of Compounded Sterile Preparations | 267 | ||
| Ch 18 Finished Preparation Release Checks and Tests | 275 | ||
| Ch 19 Microbiological Issues in Compounding Sterile Preparations | 285 | ||
| Ch 20 Handling Sterile Commercial Products and Compounded Sterile Preparations Within the Pharmacy | 301 | ||
| Ch 21 Maintaining Sterility, Purity, and Stability of Dispensed and Distributed CSPs | 313 | ||
| Ch 22 Batch Compounding | 321 | ||
| Part II: QualityManagement | 331 | ||
| Ch 23 Pharmacist Education | 333 | ||
| Ch 24 Pharmacy Technician Education, Certification, Training, Evaluation, and Regulation | 341 | ||
| Ch 25 Secondary Engineering Controls | 351 | ||
| Ch 26 Sterile Compounding Technology | 381 | ||
| Ch 27 Cleaning and Disinfecting | 427 | ||
| Ch 28 Environmental Quality and Control | 443 | ||
| Ch 29 Dealing with Latex Allergies | 455 | ||
| Ch 30 Personnel Training and Competency Evaluation | 463 | ||
| Ch 31 Policies, Procedures, and Quality Assurance Programs | 471 | ||
| Ch 32 Outsourcing the Compounding of Sterile Preparations | 491 | ||
| Part III: Appendixes | 505 | ||
| Appendix A ASHP Guidelines onCompounding Sterile Preparations | 507 | ||
| Appendix B ASHP Guidelines on Handling Hazardous Drugs | 535 | ||
| Appendix C Selected ASHP Guidelines Pertaining to Sterile Compounding | 563 | ||
| Appendix D Selected Websites Pertaining to Compounding Sterile Preparations | 565 | ||
| Glossary | 569 | ||
| Index | 585 |