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

E3 Question: I have been contacted by several vendors selling services that relate to complying with 797 regs. The latest outfit claimed that according to new 797 regulations effective Jan 1st 2008, that all Chemotherapy preparation done in a vertical flow biohazard cabinet must be done in a completely different clean room with a separate ante area from our regular clean room and ante area. Is this true or is this hype to get me to subscribe to their service. Also, what is the best way to know the regulations and comply with them?

E3 Answer: At this time, there are no new official 797 regulations.  The official and current USP Chapter <797> in effect is the same one that was published on January 1, 2004.  There has been a lot of speculation as to when the new regulations will become effective.  The USP Sterile Compounding Committee is working hard to review the submitted comments and finalize the chapter as soon as possible.  Several states have changed their pharmacy rules and regulations in order to harmonize with the USP chapter.  Check with your specific state board of pharmacy for more information.  Re: preparation of hazardous drugs.  One of the recommendations in the proposed revisions is that pharmacies that compound more than 5 hazardous drugs per week, require a separate negative-pressure room.   This is currently only a recommendation.  The proposed changes are available online (for free) from USP at the following URL: http://www.usp.org/USPNF/pf/generalChapter797.html

(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