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FDA today issued a proposed rule to revise the labeling and storage requirements for blood and blood components including source plasma, which combines, simplifies, and updates regulations related to blood container labeling and to the storage and shipping temperatures of frozen blood components. This rule will make it easier for the blood industry to comply with existing regulations and manage the supply of plasma to further enhance the safety of the blood supply while reducing the cost of regulatory compliance through greater efficiency.
Plasma is the fluid portion of blood collected from donors which may be used
for transfusion purposes or further manufactured into blood derivatives such
as anti-hemophilic factor. Source plasma is plasma that is
collected by plasmapheresis (automated collection) as a source for further
manufacturing use.
The proposed new regulations would:
The proposed rule can be found on the FDA website at http://www.fda.gov/cber/rules.htm.
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