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FDA Proposes New Rules to Revise Blood Storage and Container Labeling Requirements

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:

• consolidate labeling requirements for blood and blood components into a single section of the regulations, as a convenience to users.
• provide more flexibility to allow use of an internationally standardized container label format for blood and blood components which will harmonize the placement of important information such as blood type on the label with other countries. This may help reduce medical errors.
• include provisions for changing some of the storage and shipping temperatures for frozen non-cellular blood components to help ensure the potency of these components by preventing degradation of the heat sensitive factors such as factor VIII which is used to treat hemophilia.
• include changes to shipping and storage temperatures which will provide blood establishments greater flexibility in inventory management.

The proposed rule can be found on the FDA website at http://www.fda.gov/cber/rules.htm.

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