Regulatory Focus™ > News Articles > Rules for Blood Testing, Storage Changed

Rules for Blood Testing, Storage Changed

Posted 29 August 2012 | By

The U.S. Food and Drug Administration (FDA) is changing the rules for human blood testing and storage, according to a report by in-Pharma Technologist.

A new procedure issued by FDA allows for exceptions or alternatives with regard to blood, blood components or blood products. Requests for such exceptions or alternatives should be made in writing.

Manufacturers can store thawed plasma at 1 to 6 degrees Celsius for up to 24 hours, according to the news report. Donors with blood samples previously testing positive for HIV and HCV antibodies will not have to have future samples tested since it can be assumed future samples will also contain those antibodies.

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