Advocacy & Practice Updates — Clinical Updates

FDA Releases Revised Draft Guidance on Repackaging Biologics Providing Pathway to Extend BUDs

Today, the Food and Drug Administration (FDA) released its Revised Draft Guidance: Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application with a 60-day comment period.

While the ASRS is still reviewing the new guidance, we are pleased that the FDA has offered a pathway for outsourcing facilities (503Bs) to extend the beyond-use dates (BUDs) for repackaged biologics beyond 5 days. Some outsourcing facilities have already been following many of the procedures outlined in Appendix A and B.

When we complete our analysis, we will issue a full report.

We would like to thank our over 300 members who joined us in writing comment letters to the FDA requesting that BUDs be established based on solid science rather than an arbitrary date.

In its official comment letter to the FDA, the ASRS specifically requested that the agency allow outsourcing facilities to conduct product-specific stability tests to extend the BUDs beyond the default set in the original draft guidance. 

(Published 1.12.17)