Questions and Answers on USP Chapter 797 with Clyde Buchanan:

• Question B6: Low-Risk Compounding -What is meant by time of storage periods versus time of administration?
   
• Answer B6: USP 797 states that, in the absence of sterility testing, storage periods (i.e., the time between completion of preparation and beginning of dose administration to a patient) must not exceed limits, e.g., less than or equal to 48 hours at room temperature for a low-risk preparation. Administration time is that period over which the sterile preparation is actually being given to a patient. The administration time might range from a few seconds for an IV push preparation to several days for a sterile preparation inside an implantable pump. Sterile preparations that are administered over several days are defined as medium-risk preparations, assuming that all components were commercially available sterile products.

Answer provided by E. Clyde Buchanan, MS, FASHP,  Senior Director of Pharmaceutical Services for Emory Healthcare. He is also Adjunct Professor at the Mercer University, Southern School of Pharmacy. He received his B.S. Pharmacy degree from the University of North Carolina and MS/Residency from The Ohio State University. For six years he was Assistant Director of Pharmacy at Duke University Medical Center, then served as Director of Pharmacy at St. John's Hospital in Springfield, Illinois for 11 years before going to Emory.

He has served the American Society of Health-System Pharmacists as Chair, Special Interest Group on Administrative Practice; Vice Chair, Council on Legal and Public Affairs; and member of the House of Delegates, as wel as on several committees and task forces and invited writer for several ASHP publications, including Compounding Sterile Preparations, 2nd edition.

Mr. Buchanan has authored many papers, book chapters, and two books, and he has spoken on a national and international level on a variety of clinical and administrative pharmacy topics.

All opinions expressed in the following interview are those of Mr. Buchanan. When evaluating specific recommendations regarding compounding practices, practitioners are strongly encouraged to rely on a wide array of sources, including state and local authorities, accrediting bodies such as the Joint Commission on Accreditation of Healthcare Organizations, and organizations such as the United States Pharmacopeia, as well as experts such as Mr. Buchanan.