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

• E29 Question: I am a pharmacist working for a Clinical Research Organization. The CRO has always contracted out pharmacy services, and has just now hired me to be a full time in house pharmacist. I would like to know what we are required to have in order to be current with USP 797 standards.
   
• E29 Answer:  I would recommend the following resources in order to know what is required to be current with the chapter.

  1. Visit ASHP website http://www.ashp.org/s_ashp/cat1c.asp?CID=479&DID=521, Compounding Resource Page and go to the "Getting Started" section. Read the ASHP Discussion Guide for USP Chapter <797> and check out the other material on the page.

  2. Visit USP website http://www.usp.org/USPNF/pf/generalChapter797.html  and download and read the revised chapter.

  The majority of our extracts ... indicate expiration
  dates on the multidose vials. Once the vials are opened and stored
  appropriately according to manufacturer, does the 28 day discard policy
  still apply?

(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