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

• E11 Question: Our clients are hearing rumors that the required full implementation schedule for USP 797 is no longer 1/1/08 but has been moved back. Is this true?
   

• E11 Answer:  The full implementation schedule was established by the Joint Commission (formerly JCAHO) and was an arbitrary timeline to allow institutions to get the capital budgets to make the necessary physical plant changes.  The Joint Commission has reversed their position somewhat and considers USP Chapter <797> a best practice document.  It is unclear how the Joint Commission is handling this matter. Technically speaking, all pharmacies have had to comply with the requirements of USP Chapter <797> since January 1, 2004.  Depending on the state that your client is in, the Board of Pharmacy may have a different expectations of compliance.  It is critical to determine what the State Board of Pharmacy's laws and regulations are and meet those timelines.

(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