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

• E14 Question: I work at military hospital in an outpatient oncology clinic. Currently we schedule our patients for lab work wait on the results and then
  dependent upon the results of the labs we administer the chemotherapy. We the nurses, have always mixed the chemo ourselves in a sterile environment. We mix the chemotherapy and immediately (immediately meaning <1-2 minutes after preparation) administer it to the patients. Does USP 797 apply to our situation? This is becoming a very big debate at our facility.
   

• E14 Answer:  USP 797 applies to all settings or locations where compounded sterile preparations are stored, prepared, handled or transported.  The immediate-use exemption cannot be applied to the preparation of chemotherapy.  What type of sterile environment to prepare these doses?  Hopefully you are using a Biological Safety Cabinet in a limited access room while properly garbed.  

(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