REGULATORY UPDATE: FDA Updates Biological Product Deviation Codes, Blood and HCT/P Product Codes

The Food and Drug Administration recently updated the list of Biological Product Deviation Reporting and HCT/P Deviation Reporting – Deviation Codes for fiscal year (FY) 2024.

In response to the FDA’s May 2023 guidance that recommends determining blood donor eligibility based on an individual donor assessment, the agency added or modified several biological product deviation codes (described on pages 1-3 of the document). These changes include adding new codes related to sex with a new partner and new codes for sex with more than one partner. The agency also modified codes related to the use of medication to treat or prevent HIV infection to clarify FDA-reportable events.

There were no changes to deviation codes for human cells, tissues, and cellular and tissue-based products (HCT/Ps) in 2024.

FDA also updated blood product codes for FY24, which includes the following additions:

• Apheresis PF24 plasma thawed (DC42).
• Apheresis PF24RT24 plasma thawed (DC43).
• Cold-stored apheresis platelets leukocytes reduced (DC44).
• Cold-stored apheresis platelets leukocytes reduced, pathogen reduced (DC45).

There are several new non-blood product codes for FY2024, which includes additions to in vitro diagnostics (1 code), derivatives (1 code), HCT/Ps (2 codes), gene therapy products (5 codes) and fecal microbiota products (3 codes).

Those with questions may contact AABB Regulatory Affairs.