US FDA revises blood storage and testing rules for manufacturers

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US FDA revises blood storage and testing rules for manufacturers
The US FDA has revised storage and testing requirement for human blood intended for transfusion or further manufacturing.

According to a document published yesterday​ manufacturers can now store thawed fresh frozen plasma at 1-6°C for 24 hours

Additionally, pharmaceutical manufacturers will no longer have to test blood samples for HIV and HCV from donors whose previous samples have tested positive for HIV and HCV antibodies, which indicates that  they have been exposed to the infections.

The FDA said: “These donors participate in a Source Plasma High Risk Donor program and their plasma with be used for further manufacturing into non-injectable products​.”

The revisions update the original guidance, which is available here​. 

Related topics: Regulatory & Safety, Regulations

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