General requirements for blood, blood components, and blood derivatives; donor notification. Final rule

The Food and Drug Administration (FDA) is amending the biologics regulations to require blood and plasma establishments to notify donors, including autologous donors, whenever the donor is deferred or determined not to be suitable for current or future donations of blood and blood components. A donor is deferred based on results of tests for communicable disease agents or determined not to be suitable for donation based on failure to satisfy suitability criteria. Blood and plasma establishments also are required to notify the referring physician of an autologous donor when the autologous donor is deferred based on tests for evidence of infection with a communicable disease agent(s). A standard operating procedure (SOP) and recordkeeping also are required. This final rule is intended to help protect public health and to promote consistency in the industry. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule on the requirements for testing human blood donors for evidence of infection due to communicable disease agents.