Can the expiration date of a vaccine be extended?
The expiration date of a biological product may be changed pursuant to 21 CFR 610.50, which states, in part, that the date of manufacture shall be the date of initiation by the manufacturer of the last valid potency test. Under 21 CFR 610.53 (b), the dating period for a product shall begin on the date of manufacture, as prescribed in section 610.50. A valid potency assay is required prior to an extension of dating. The expiration date is based on the last valid potency assay. Any decision made to extend the dating period of a vaccine is predicated and sustained by the data submitted by the manufacturer that verifies the sterility and potency of the product. If the manufacturer can assure FDA, through sound scientific data, that the product is still sterile and potent even after the recommended dating period then (on a case-by-case basis) extending the dating period on the label will be permitted.
