According to the CDC Immunization Program, vaccines must be used and discarded based on the manufacturer’s expiration date and instructions for use, not an arbitrary timeframe. QUAD A aligns with this approach, applying it to all vaccines—whether they are part of the CDC or state immunization programs or purchased directly by healthcare facilities.
QUAD A expects accredited facilities to manage vaccines in strict accordance with the manufacturer’s instructions for use, including:
- Maintaining the correct storage temperature.
- Conducting temperature checks at the required frequency.
- Adhering to all applicable regulatory requirements.
QUAD A-accredited facilities must adhere to CDC guidelines and manufacturer instructions for the safe and effective use of multiple-dose vaccine vials (MDVs). Below is a summary of key considerations:
General Guidelines for MDVs (Excluding COVID-19 Vaccines):
- Vaccines in MDVs that do not require reconstitution typically contain preservatives and may be used through the expiration date printed on the label, provided the vaccine remains uncontaminated and the manufacturer has not specified otherwise.
- Example: Inactivated polio vaccine in an MDV can be used through the expiration date on the vial.
Beyond-Use Date (BUD):
- For some vaccines, the manufacturer specifies a "beyond-use date" (BUD) once the MDV has been entered, or the rubber stopper punctured, or once the vaccine has been reconstituted. This indicates the vaccine must be used within a certain number of days.
- Example: Some inactivated influenza vaccines must be discarded within 28 days after the stopper is pierced.
- Facilities must discard any vaccine not used within the BUD. (the BUD can never extend past the expiration date on the vial)
Package Inserts:
- Specific BUD information can be found in the vaccine’s package insert. QUAD A-accredited facilities are encouraged to review these inserts regularly, which are available at www.immunize.org/fda.
COVID-19 Vaccines:
- COVID-19 vaccine MDVs do not contain preservatives and must be used within hours after puncturing the vial. The exact timeframe varies by product.
- Facilities must follow the most current CDC and manufacturer guidance for COVID-19 vaccine storage and handling.
QUAD A Compliance:
- QUAD A-accredited facilities are expected to maintain strict adherence to CDC guidelines and manufacturer instructions for vaccine storage, handling, and administration. This includes proper documentation of expiration dates, BUDs, and disposal of expired or contaminated vaccines.
- Regular staff training and internal audits are recommended to ensure compliance with these standards.
For further clarification, please submit your question to QUAD A standards@quada.org or refer to the CDC’s vaccine storage and handling guidelines.
Reference: Vaccine Storage and Handling | Vaccines & Immunizations | CDC Vaccine Storage and Handling Toolkit - January 2023
Since 1980, QUAD A (a non-profit, physician-founded and led global accreditation organization) has worked with thousands of healthcare facilities to standardize and improve the quality of healthcare they provide – believing that patient safety should always come first.
