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        Blood & Blood Products

Regulation of the Blood Supply

                        
                Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
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          Blood & Blood Products
          Regulation of the Blood SupplyBlood & Blood Products Regulation of the Blood Supply
  	
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    PrintFDA/CBER is responsible for regulatory oversight of the U.S. blood supply. FDA promulgates and enforces standards for blood collection and for the manufacturing of blood products, including both transfusible components of whole blood, pharmaceuticals derived from blood cells or plasma, and related medical devices. FDA also inspects blood establishments and monitors reports of errors, accidents and adverse clinical events. CBER works closely with other parts of the Public Health Service (PHS) to establish blood standards, and to identify and respond to potential threats to blood safety or supply.

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Keeping Blood Transfusions Safe: FDA's Multi-layered Protections for Donated Blood
	Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
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                                                                                  Content current as of:
      05/11/2023
                  
                   
Regulated Product(s)
		 Biologics
			  			     			  						              
			
			 
			  Blood ProductsRegulation of the Blood Supply                
                          

                        Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
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