REGULATORY UPDATE: FDA Updates Biological Product Deviation Reporting Codes

The Food and Drug Administration updated the list of biological product deviation (BPD) reporting codes for fiscal year (FY) 2025 on Tuesday. The agency made no changes to the BPD codes for human cells, tissues, and cellular and tissue-based products (HCT/Ps) for FY2025.

FDA made two changes to deviation codes for blood labeling and one to quality control and distribution:

• Pathogen reduction status incorrect or missing (LA-81-19).
• Crossmatch tag, tie tag or transfusion record incorrect or missing applicable information (LA-82).
• Product distributed prior to resolution of discrepancy (QC-94-08).

There were no changes to the BPD blood product codes. There are several new non-blood product codes for FY2025, which includes additions to in vitro diagnostics (6 codes), derivatives (1 code), HCT/Ps (1 code) and gene therapy products (5 codes).

Those with questions may contact AABB Regulatory Affairs.