Blood container labeling

FDA proposed to revise its rule on the labeling and storage requirements for blood and blood components to make it easier for the blood industry to comply with regulations, reduce the costs of compliance, and manage the supply of plasma to enhance the safety of the blood supply.

The proposed revisions would

• consolidate labeling requirements for blood and blood components into a single section of the regulations;

• provide more flexibility to allow use of an internationally standardized container label format that will harmonize the placement of important information such as blood type on the label with other countries;

• include provisions for changing some of the storage and shipping temperatures for frozen noncellular blood components; and

• include changes to shipping and storage temperatures that will allow greater flexibility in inventory management.

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