REGULATORY UPDATE: AABB Resource Highlights Crucial Regulatory Options Already Available from FDA to Support Blood Availability

By Drew Case posted 01-20-2022 10:23 AM


Based on concerns and questions from hospitals and blood centers about inventory management strategies, AABB has confirmed its understanding with the Food and Drug Administration to help members identify existing flexible shipping options that are widely misunderstood. FDA’s clarification is included in the AABB resource “Blood Supply: Summary of Crucial Regulatory Options Already Available from FDA.”

The document clarifies crucial regulatory options available to facilities today:

  • to correct widespread misconceptions on shipping limitations.
  • to clarify that hospitals and unlicensed blood centers can ship licensed products across state lines.
  • to increase your ability to move licensed blood components in response to patient needs.
  • to prevent the unnecessary outdating of blood products during this challenging time for the blood supply.

AABB encourages hospitals to continue to work closely with their blood suppliers who are striving to meet supply needs. Careful consideration of the existing regulatory options captured in the summary may provide additional support with unprecedented supply challenges.