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

• E4 Question: I am inquiring if there is any information that is listed in the USP 797 guidelines that limit's the on floor hang time of Intralipid emulsions not drawn up but dispensed in original bag? I have recently heard through colleagues that due to USP 797 practices that Intralipid in the original bag is only allowed to hang for 12 hours no longer once hung on the  set on the floor.  I am trying to figure out if this is a USP 797 requirement or if it is a suggestion from the manufacturer.  If you could please send me any information you have on this subject I would greatly appreciate it.  Thank you for your time.
• E4 Answer: In the current, official and enforceable version of USP <797> states that lipid-based emulsions administration must be completed within 12 hours of preparation.  Fat emulsion and propofol are very good growth media for microorganisms have been implicated in several incidents of microbial contamination.  In the current proposed revision of USP Chapter <797>, this statement has been removed because USP Chapter <797> pertains only to all pre-administration manipulations and procedures of CSPs, including preparation, storage, and transportation. The standards in this chapter do not pertain to the clinical administration of CSPs to patients via application, implantation, infusion, inhalation, injection, insertion, instillation, and irrigation, which is the route of administration. There are other organizations such as ASPEN and ASHP that have recommendations when hanging fat emulsion that you might want to consult. 

(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