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

• E22 Question: We have several clerkships where sterile compounding is a part of the clerkship. These clerkships are six weeks in length. There are some people recommending that students who go these clerkships should perform a media fill and complete a written exam two weeks before the start of the clerkship. They already do this as part of the compounding course that they take in their second year. However, by the time they are ready to go these clerkships, that certification has expired. How does USP 797 apply to experiential education? Are these students who are there for a short period of time considered "pharmacy personnel"?
   

• E22 Answer:  Thanks for the question.  USP 797 has three tiers of training stipulated in the chapter.  They are didactic lessons with exam, psychomotor skill assessment (observational audit) and aseptic media fill.  I understand the challenge facing pharmacy students and technicians in maintaining their skills and competency.  If a student has evidence of meeting these requirements (annually for low and medium-risk level and semi-annually for high-risk level) then I would consider them pharmacy personnel.  The final determination of their status needs to be determined by the clerkship site.  If you any other questions, please call me.  

(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