Recommendations for Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Possible Exposure to Anthrax Guidance for Industry October 2001

GUIDANCE DOCUMENT

• Docket Number: FDA-2001-D-0488
• Issued by: Center for Biologics Evaluation and Research

This guidance document provides the current recommendations of the Food and Drug Administration (FDA) for assessment of donor suitability and product safety for donors potentially exposed to Bacillus anthracis, the agent of anthrax. This guidance applies to Whole Blood, blood components (including recovered plasma) and Source Plasma collections intended for use in transfusion or for further manufacturing into injectable products. FDA developed the recommendations in this guidance in consultation with other Public Health Service Agencies and with the Blood Safety Committee of the Department of Health and Human Services.

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