FDA Publishes Guidance on Circular Information for the Use of Human Blood and Blood Components

FDA Publishes Guidance on Circular Information for the Use of Human Blood and Blood Components

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The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research, are recognizing as acceptable for use by, manufacturers of blood and blood components intended for transfusion subject to United States statutes and regulations the instruction circular entitled “Circular of Information for the Use of Human Blood and Blood Components” (Circular) dated August 2009. The August 2009 Circular provides specific labeling instructions for the administration and use of blood and blood components intended for transfusion. We believe that the Circular will assist you in complying with labeling requirements under 21 CFR 606.122 (§ 606.122). The requirements under § 606.122 specify that an instruction circular must be available for distribution with blood and blood components intended for transfusion. Section 606.122 further specifies the information that is required in the instruction circular. This guidance supersedes the guidance of the same title dated December 2003.

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