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VACCINE STORAGE AND HANDLING TOOLKIT
SECTION FOUR: Vaccine Inventory Management
Understanding Expiration Dates
All vaccine products, like other medications, have an expiration date,
sometimes referred to as the expiry date. The expiration date is
determined by the manufacturer.
The expiration date is the final day that the vaccine can be
administered. Vaccines past the expiration date should NEVER be used.
Determining when a vaccine or diluent expires is a critical step in
maintaining proper storage and handling. Understanding vaccine
expiration dates can help save your practice time and money.
When the expiration date has only a month and year, the product may be used up to and including the last day of that
month. If a day is included with the month and year, the product may only be used through the end of that day.
In some instances, such as the examples for beyond-use date (BUD) below, vaccines must be used before the
expiration date on the label.
Beyond-Use Dates
Some vaccines have a beyond-use date/time. The Beyond-use date is different from expiration date. The beyond-
use date, or BUD, is the last date or time that a vaccine can be safely used aer it has been moved from one storage
state to another (e.g., frozen to refrigerated) or prepared for patient use. It is a new deadline aer which the product
should not be used. The BUD varies by product and type of transition. This is sometimes also called a beyond-use
time if it falls on the same day at a different time of day.
Unlike the expiration date that is determined by the manufacturer, the BUD is determined by the health care provider
using guidance provided by the manufacturer. The BUD replaces the manufacturer’s expiration date but never
extends it. Always use the earlier date between the two.
Not all vaccine products have a BUD. The package insert or Emergency Use Authorization (EUA) Fact Sheet for
Healthcare Providers will specify if there is a BUD and how to calculate it. Always review this informational material
to determine if a BUD applies. Examples of BUD include:
Reconstituted vaccines have a limited period for use once the vaccine is mixed with a diluent. If a reconstituted
vaccine is not used immediately, follow manufacturer guidance for storage conditions and time limits. Additional
information can be found here.
Multidose vials might have a specified period for use once they have been punctured with a needle. For example, the
package insert may state that the vaccine must be discarded 28 days aer the first puncture with a needle. If the vial
is first punctured on 06/01/2023, the BUD is 06/29/2023. The vaccine should not be used aer the BUD.
Manufacturer-shortened expiration dates may apply when vaccine is exposed to inappropriate storage conditions.
The manufacturer might determine the vaccine can still be used, but will expire on an earlier date than the date on
the label. The BUD should be noted on the vial label along with the initials of the person making the calculation.
Expiration Dates
The vaccine
coordinator (or other
designated person) should remove
expired vaccine and diluent immediately
from the inventory.
Vaccine Disposal
General vaccine disposal guidelines for:
• Expired or compromised vaccine—sometimes unused vaccine and diluent doses, unopened vials, expired vials,
and potentially compromised vaccine may be returned for credit, even if they must be discarded. Contact your
immunization program
*
and/or the vaccine manufacturer for vaccine-specific information.
• Open and broken vials and syringes, manufacturer-filled syringes that have been activated, and vaccine
predrawn by providers—these cannot be returned and should be discarded according to your state requirements.
• Empty vaccine vials—most are not considered hazardous or pharmaceutical waste and do not require disposal in a
biomedical waste container.
†
However, check and comply with your state requirements for disposal.
Medical waste disposal requirements may vary from state to state because they are set by state environmental agencies.
Contact your immunization program
*
or state environmental agency for guidance to ensure your facility’s vaccine
disposal procedures comply with state and federal regulations.
* Contact your immunization program for details about specific state or local regulations impacting this activity.
† While vials are not usually considered hazardous or pharmaceutical waste, an empty RV dispensing tube or oral applicator is considered medical
waste and should be disposed of in a medical waste container.