Questions and Answers on USP Chapter 797 with Clyde Buchanan:

• Question B30: Storage and Beyond Use Dating - What is the difference between an expiration date and a beyond-use date?
   
• Answer B30: An expiration date is the shelf-life of a commercially available product as labeled on the product by the manufacturer. Compounding personnel must assign beyond-use dates for CSPs based on the stability of the finished preparation, combination of ingredients and container, shipping conditions, storage conditions, and administration conditions. Compounding personnel must understand the chemical and physical factors that affect the sterility and stability of all components in a CSP. Beyond-use dates must be part of an appropriate CSP label.

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.