Reporting Nonviable Vaccines

Key Terms 

TermGuidance
Spoiled nonviable, returnable 
Careful storage and handling should minimize spoiled vaccines. Vaccines still in their original container (vial or syringe) are considered spoiled and nonviable if vaccine manufacturer has determined that vaccines were exposed to out-of-range temperatures. Vaccines could spoil as a result of the following conditions:  
– natural disaster or power outage  
– refrigerator or freezer temperatures that are too warm  
– refrigerator temperatures that are too cold
– failure to store vaccines properly upon receipt  
– vaccines spoiled during transport  
– mechanical failure  
– unmonitored temperatures
Expirednonviable, returnable 
Careful vaccine management (including stock rotation) should minimize expired vaccines. Vaccines are considered expired
– if vial dates are past  
– manufacturer expiration date on vials 
– beyond-use date after reconstitution, puncture of multidose vials, or
– manufacturer-shortened expiration dates due to inappropriate storage conditions 
Wastednonviable, not returnable 
Careful vaccine management and administration should minimize wasted vaccines.  Vaccines may be designated as wasted (and disposed of following practice protocols) because of the following conditions:  
– vaccines are deauthorized by FDA 
– vaccines drawn into syringe but not administered 
– insufficient volume to draw a dose 
– exceeded maximum number of doses per vial 
– damaged vials (e.g., due to a drop causing damage to vial integrity or sterility) 
– lost or unaccounted for vaccines 

Handling Returns 

Providers may return spoiled and expired vaccines to McKesson Specialty for excise tax credit. Wasted vaccines must be disposed of following practice protocols. 

Return Labels 

Providers may request return labels in myCAvax

By email:  UPS return labels are emailed to the Primary Vaccine Coordinator from UPS Quantum View [mail to: pkginfo@ups.com] and with subject line “UPS Label Delivery.” Ensure this email address is not blocked by email spam filters. Returns are processed daily from Monday through Friday, and emails should arrive within one business day. 

By standard mail:  Return labels are enclosed in an envelope addressed to the practice name and address, marked to the attention of the Vaccine Contact, and stamped with “Return Label for Expired Vaccines” printed in a large red font. Return labels should arrive within 3-5 business days. If you do not receive your return label from McKesson within 7 days, contact the Provider Call Center (or VFC Program for VFC vaccines) for assistance. 

Packaging Vaccines for Return 

Return nonviable vaccines within 30 days to prevent expiration of return label. Key points: 

  • Clearly label the outside of the shipping container “Non-viable Vaccine Enclosed” and return to the address listed on the prepaid shipping label provided by McKesson.  
  • Return the exact vaccine products and quantities as reported in myCAvax for the waste event. (Submit a new report for return of additional vaccine doses or products.) 
  • For multiple return labels, package all vaccines together with one return label posted on the outside of the shipping container and all other labels inserted inside carton with vaccines. Return labels do not include any identifying details to match with a return waste event. 
  • To avoid UPS pickup fees, drop off at a UPS location, or deliver to your UPS driver with other outbound shipments.

How to Report  

Gloved hand checking off boxes in vial lab icon