REGULATORY UPDATE: FDA Revises SOP Reporting Requirements for Blood Establishments

October 14, 2026

The Food and Drug Administration updated two final guidance documents to revise how licensed blood establishments report changes to their standard operating procedures (SOPs).

The updates apply to “Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements,” issued in October 2023, and “Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy,” issued in July 2024.

The October 2026 updates revise the “Implementation” sections in both guidances. The agency now requires relevant SOP changes to be reported in annual reports under 21 CFR 601.12(d) rather than through a “Changes Being Effected” supplement.

No additional substantive changes were made to either guidance.

Members with questions may contact AABB’s Department of Regulatory Affairs.