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

• E5 Question: In reviewing the literature, both past and present USP 797 materials, I have come across the following:

Assuming opened:
- Expiration of multidose vials should not exceed 30 days.
- All multidose vials should discarded after 28 days.
- All multidose vials should be discarded after 30 days except for insulin and vaccines.
- Insulin should have a 28 days expiration
- Vaccines can, if properly stored, be used for the length of the expiration date on the bottle.
- What is the consensus on expiration dating of opened multidose vials, including insulin and vaccines. 

• E5 Answer:  In the official version of USP Chapter <797>, effective January 1, 2004 the following language can be found:

"If multiple-dose parenteral medication vials (MDVs) are used, refrigerate the MDVs after they are opened unless otherwise specified by the manufacturer. Discard the MDVs when empty, when suspected or visible contamination occurs, or when the manufacturer’s stated expiration date is reached, provided the manufacturer’s storage conditions have been adhered to. Expiration dating not specifically referenced in the package insert should not exceed 30 days once the vial has been opened."

In the in-process revision of the USP Chapter <797>, the PROPOSED language can be found:

Multiple-dose containers (e.g., vials) are formulated for removal of portions on multiple occasions because they contain antimicrobial preservatives. The beyond-use date after initially entering or opening (e.g., needle-punctured) multiple-dose containers is 28 days (see Antimicrobial Effectiveness Testing <51>), unless otherwise specified by the manufacturer.

If the vial is labeled as a multidose vial or container then the dating should not exceed 28 days UNLESS the manufacturer has data to support longer dating.

(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