Questions and Answers on USP 797: Answers Provided by Eric S. Kastango, MBA, RPh, FASHP:

• E26 Question: I am a pharmacist here in Texas and I am working on updating our policies on UPS 797. Can you tell me the main differences between 2007 and 2008? I do understand that they will be effective by June 2008.
   

• E26 Answer:  I am unclear with regard to the which iteration of USP Chapter 797 you are referring to.  If you are speaking about the proposed revisions and what was finally approved, the most significant differences involve environmental monitoring and a few things that were not in the proposed revisions but were added based on the substantive comments received by the USP Sterile Compounding Committee.   The most effective way to understand what needs to be done once the chapter is in effect in June 2008 is to read the chapter and compare them against your policies. The Shalls and Shoulds appendix in the revised chapter is an excellent resource to aid you in your endeavor.

(Answer provided as a courtesy to usp797.org by Eric S. Kastango, MBA, RPh, FASHP. Please note that usp797.org is not responsible for this answer.)

• About Eric S. Kastango: Since its inception, Eric S. Kastango has been at the forefront of USP <797>. He is an elected member of the United States Pharmacopoeia Sterile Compounding Committee (2005-2010). Over the years, he has held multiple American Society of Health-System Pharmacists chairmanships and committee positions. He was responsible for creating the “Comprehensive Sterile Compounding Compliance Gap Analysis and Risk Assessment Tool.” In this capacity, Mr. Kastango frequents pharmacy events as an expert speaker, contributes to industry journals, and teaches. Mr. Kastango received his Bachelor of Science in Pharmacy degree from the Massachusetts College of Pharmacy and Allied Health Sciences and a MBA from the University of Phoenix. Since 1980, he has practiced pharmacy in a number of practice settings (including hospitals, community, and home care) in a number of different of roles, including the Corporate Vice President of Pharmacy Services for Coram Healthcare Corporation, which has 72 pharmacies in 44 states. He has also managed a FDA-registered cGMP manufacturing operation for Baxter Healthcare Corporation, and has made over 100 presentations on a variety of pharmacy practice topics.  Mr. Kastango is the President and CEO of Clinical IQ, and can be reached as follows:

Mr. Eric S. Kastango – President and CEO
Clinical IQ, LLC 
184 Columbia Turnpike, #282 
Florham Park, NJ  07932 
Tel: (973) 765-9393 --- www.clinicaliq.com