Vaccine Inventory Management

Vaccine Delivery

Maintaining the cold chain is the first step in vaccine inventory management. Staff members who might accept vaccine deliveries should be trained to immediately notify the primary or backup vaccine coordinator when deliveries arrive. Vaccines must always be immediately checked and appropriately stored upon arrival.

Unpacking Deliveries

☑ 🖍 Vaccines and diluents must be carefully unpacked, stored at the recommended temperatures, and documented immediately upon arrival.

Do not place an unopened or unpacked shipment box in a vaccine storage unit, as the cool packs shipped with the vaccine may cause the packaged vaccine to become too cold.

☑ 🖍 Immediately inspect shipments to ensure receipt of the correct vaccine types and quantities, and to look for any signs of damage.

• Examine the shipping container and vaccines for signs of physical damage.
• Immediately check the cold chain monitor (CCM)—a single-use device that tracks vaccine temperatures during transport—for any signs of a temperature excursion, if one was included. After reviewing, discard the CCM as it cannot be reused.
• Immediately check both the vaccine and diluent expiration dates to ensure the products are not expired or soon-to-expire.
• Verify the contents against the packing list to ensure they match.
  • For frozen vaccines, the packing list will show the maximum time vaccines can be in transit based on the shipment date.

• If the shipment includes lyophilized (freeze-dried) vaccines, ensure the correct type and quantity of diluents accompany them.

Vaccine Inventory Accounting

Stock records are used to determine the type and number of vaccines each facility should carry to meet the needs of its patients. Stock records help maintain accurate inventory and can be in either paper or electronic form.

• At least once a month and before placing any vaccine orders, count all vaccines and diluent doses to make sure the number of doses in the storage unit matches the number of doses documented in the stock record. Always check expiration dates while counting stock and immediately remove any expired doses.
• Diluents should be documented on a separate stock record. Make sure the number of diluents matches the number of corresponding vaccines.
• If the numbers in the storage unit do not match the doses documented in the stock record, providers should enter the correct number based on the count on a separate line below the old balance on the stock record. Make a note next to the new entry indicating that the count confirmed the new balance, and sign it. Use the corrected balance for calculating future stock quantities.
• If providers receive multiple doses of the same vaccine in the same presentation from the same lot with the same expiration date, they can document these doses as one entry on the stock record. Indicate the total number of doses received, regardless of how many vials or syringes the doses came in. For example, if providers receive 10 single-dose vials of the same vaccine with the same lot number and expiration date, they can make a single entry on the stock record, noting that 10 doses were received.
• If there are discrepancies between the contents and the packing list, or other concerns about the contents, immediately notify the vaccine manufacturer. VFC or other providers who receive vaccines purchased with public funds should contact their immunization program.

At the end of each month, determine the total number of vaccine and diluent doses used that month and the amount of stock still available. At the end of each year, the stock record shows the number of doses received and used for the year. This information will help determine the facility's needs and guide future ordering to minimize waste and reduce the need for vaccine transfer and transport. It will also help to ensure a sufficient supply to meet patient needs.

Vaccine Ordering

☑ 🖍 Order and stock only enough vaccine to meet patient needs. Plan ahead.

Order vaccines after verifying current inventory and anticipating patient needs. To reduce the risk of loss during shipment or storage, place smaller, more frequent orders rather than large, infrequent ones.

Storing a larger volume than the facility needs can increase the risk of wasting vaccines if they expire or are compromised in some way (e.g., during shipping incident or due to mechanical failure of a storage unit).

Vaccine orders typically arrive within 1 to 2 weeks; however, delays may occur. When possible, avoid placing last-minute or rush orders to lessen the risk of running out of vaccines. As a general guide, reorder when inventory reaches a 4-week supply.

Stock Rotation and Removal

☑ 🖍 Regularly rotate and check vaccine stock for expired doses.

Arrange stock for each vaccine type so that doses with the earliest expiration dates are placed in front of those with later expiration dates. Remove expired vaccines and diluents immediately to avoid inadvertent administration.

Vaccine Disposal

Administration of vaccines necessarily results in waste (e.g., empty vials), and despite best efforts, sometimes unused vaccines must be disposed of. General vaccine disposal guidelines exist for:

• 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 state requirements for disposal.
  • While vials are not usually considered hazardous or pharmaceutical waste, an empty rotavirus dispensing tube or oral applicator is considered medical waste and should be disposed of in a medical waste container.
• 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 the immunization program or the vaccine manufacturer for vaccine-specific disposal 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 state requirements.

Medical waste disposal requirements are set by state environmental agencies. Contact your immunization program or state environmental agency for guidance to ensure the facility's vaccine disposal procedures comply with state and federal regulations.

Expiration Dates

Understanding Expiration Dates

Properly identifying when a vaccine or diluent expires is essential for managing vaccine inventory and preventing administration errors. All vaccine products have an expiration date (sometimes called an expiry date), which marks the final day the manufacturer guarantees the vaccine will meet standards for strength, quality, and purity. Never administer vaccines past their expiration date.

How Expiration Dates Are Determined

The Food and Drug Administration (FDA) requires manufacturers to submit stability data to support each product's proposed expiration date and storage conditions. These data verify that the vaccine remains potent and safe throughout its labeled shelf life. The expiration date is therefore the last day the manufacturer guarantees full potency and safety.

How to Read Expiration Dates

If an expiration date shows only a month and year, the vaccine may be used through the last day of that month. For example, a product labeled 12/2026 is valid through 11:59 p.m. on December 31, 2026, and expires at 12:00 a.m. on January 1, 2027.

If the expiration date includes a specific day, the vaccine may be used only through the end of that day. For example, a product labeled 6/15/2027 is valid through 11:59 p.m. on June 15, 2027, and expires at 12:00 a.m. on June 16, 2027.

For vaccines requiring reconstitution, the diluent and antigen components may have different expiration dates, even when packaged together.

When Manufacturers Update Expiration Dates

Manufacturers may extend an expiration date when new stability data become available. If the expiration date is extended beyond what appears on the label, manufacturers typically communicate the change through the FDA's Expiration Dating Extension website or through mass communications such as "Dear Health Care Provider" letters. Manufacturer-extended expiration dates should be written on the vial or manufacturer-filled syringe, initialed by the person making the change, and recorded in inventory records.

If a vaccine has been exposed to inappropriate storage conditions (e.g., temperature excursion), the manufacturer might determine the vaccine can still be used but expires earlier than the date on the label. The manufacturer-shortened expiration date must be written on the vial or manufacturer-filled syringe, initialed, and documented in inventory records. This ensures clarity for all staff and prevents inadvertent use of compromised vaccine.

Beyond-Use Dates

Understanding Beyond-use Dates

Some vaccines must be used before the expiration date because they have a beyond-use date (BUD)—an earlier deadline after which the product should not be used. Unlike the manufacturer-set expiration date, the BUD is calculated by the provider based on manufacturer guidance.

The BUD is the last date or time a vaccine can be safely used after it has been:

• Moved from one storage state to another (e.g., frozen to refrigeration).
• Prepared for administration (e.g., reconstituted).
• First punctured with a needle (for multidose vials).

The BUD varies by product and type of transition. If the BUD falls on the same day (e.g., 4 hours after transition), it may also be called the beyond-use time.

Not all vaccines have a BUD. The manufacturer's package insert or Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers will specify when a BUD applies. Always review these materials to confirm BUD requirements.

Calculating a BUD

• Begin counting with day 0—the date the vaccine was transitioned (e.g., moved to refrigerator)
• Calculate the number of days or hours allowed, based on manufacturer guidance.
• Write the BUD on the vaccine label and initial it.
• The BUD replaces the manufacturer's expiration date, but never extends it. Always use the earlier date.

When a BUD Applies

Vaccines transitioned between storage states

Once a vaccine is moved from one storage condition to another, it has a limited time for use. Frozen vaccines must be thawed before administration. Always follow the guidance in the manufacturer's package insert for thawing instructions and the correct BUD.

• Example: Previously frozen lyophilized varicella vaccine may be stored in the refrigerator for up to 72 hours before reconstitution. Once placed in refrigeration, the unopened vial's BUD is 72 hours.
• Example: Moderna RSV vaccine, mResvia, may be stored in the refrigerator for up to 90 days or at room temperature for up to 24 hours before administration. In this case, the syringe's BUD is 90 days refrigerated or 24 hours at room temperature.

Reconstituted vaccines

Once mixed with its diluent, vaccines have a short window for use. If not administered immediately, follow manufacturer guidance for storage conditions and time limits.

• Example: Varicella-containing vaccines must be administered within 30 minutes of reconstitution. The beyond-use time is 30 minutes.
• Example: MMR vaccines (except MMRV) must be administered within 8 hours of reconstitution. The beyond-use time is 8 hours.

Multidose vials

Some multidose vials must be discarded a certain number of days after first puncture with a needle.

• Example: If the package insert states the vaccine must be discarded 28 days after first puncture, and the vial is first punctured on 06/01/2026, the BUD is 06/29/2026. Do not use the vaccine after this date.

Monitoring BUDs

Before preparing vaccines, staff must check the BUD on the vial or syringe. In addition, vaccine coordinators should create and maintain a system for tracking BUDs, such as a visible log near storage units, to ensure timely vaccine use and proper disposal.

VFC Reminder

VFC providers and others who administer vaccines purchased with public funds should contact their immunization program for state-specific requirements related to vaccine inventory management. State and local programs that have an immunization information system (IIS) with vaccine inventory accounting functions require VFC providers to use the IIS to track their inventory.

Icon Guide

☑ CDC Guidance

🖍 VFC provider requirement

★ Best Practices

⚠︎ Important Reminders