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

• E17 Question: I work for a regional health system in Texas. We have just opened the Occupational Health Center which will be providing occupational health to the hospital employees; as well as, the local community, industry, etc.  One of the services that we will be providing is travel health, including immunizations.  This is where the question arises.   The hospital currently has a policy that multi-dose vials of medications should be dated and discarded on the 29th day; however, the CDC guidelines indicate that immunizations are good through the expiration date on the multi-dose vial once opened.  The hospital here is struggling with this issue and how to properly store immunizations.  Many immunizations come in multi-dose vials and are very expensive.  To open a multi-dose vial of immunization that costs $700+ and then only be able to keep for 30days would not be cost effective for the hospital, nor could you reasonably pass the cost of the possible loss on the patient.
   

• E17 Answer:  If you have documentation from the CDC or the vaccine manufacturer that the medication is good through the expiration date on the vial once opened, then you can use that date.  The challenges of cost and availability were not taken lightly by the USP committee.  The MDV dating is a standard based on the multi-dose vial definition found in the General Notices section of the USP-NF.  USP 797 however provides for an exemption (dating longer than 28 days) as long as it can be supported with data.

(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