Revisions to the requirements applicable to blood, blood components and source plasma; confirmation of effective date and technical amendment. Direct final rule; confirmation of effective date and technical amendment.
The Food and Drug Administration (FDA) is confirming the effective date of February 19, 2008, for the direct final rule that appeared in the Federal Register of August 16, 2007 (72 FR 45883). The direct final rule amends the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. In addition, FDA is making technical amendments to the biologics regulations in response to comments received on the direct final rule.
D001769:Blood; D001771:Blood Banks / Q000331:legislation & jurisprudence* / Q000592:standards; D001781:Blood Component Removal / Q000592:standards*; D001800:Blood Specimen Collection / Q000592:standards*; D006801:Humans; D010949:Plasma; D011356:Product Labeling / Q000331:legislation & jurisprudence* / Q000592:standards; D014481:United States