Reducing the Risk of Human Immunodefciency Virus Transmission by Blood and Blood Products

The U.S. FDA’s Center for Biologics Evaluation and Research released a Guidance for Industry this month titled “Revised Recommendations for Reducing the Risk of Human ImmunodefciencyVirus Transmission by Blood and Blood Products.” Recommendations address various considerations relating to the minimization of HIV transmission risk, including:

• Donor deferral

• Donor requalifi cation

• Product retrieval and quarantine

• Product disposition and labeling

• Testing requirements

This guidance finalizes a draft guidance of the same title dated May 2015, and supersedes a 1992 memorandum. Like other FDA guidance, this document describes the FDA’s current thinking on this topic, and does not establish legally enforceable responsibilities on the part of industry.



Posted by Dr. Tim Sandle