Guidance on Unit of Sale/Unit of Use Lot Numbers

Issued on July 19, 2017 by AIRA, CDC

Guidance on Unit of Sale/Unit of Use Lot Numbers

This guidance clarifies the process and sets expectations for management of varied vaccine lot numbers, and shares the results of a survey of vaccine manufacturers regarding their practices in assigning Unit of Sale and Unit of Use lot numbers using a pattern, where present. This document was drafted and reviewed jointly by AIRA’s Standards and Interoperability Steering Committee (SISC) and CDC.