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          Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological ProductsSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products
					
		
		June 2015


	Download the  Final Guidance Document
	    
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    PrintDocket Number:
		    FDA-2014-D-0248
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research
          Center for Biologics Evaluation and Research


This guidance provides the pharmaceutical industry with the Center for Drug Evaluation and  Research’s (CDER’s) and the Center for Biologics Evaluation and Research’s (CBER’s) current  thinking on allowable excess volume and labeled vial fill size in injectable drug and biological  products. It replaces the draft of the same name that was published on March 14, 2014 (79 FR 14517). Specifically, the guidance clarifies the FDA regulatory requirements and  recommendations pertaining to allowable excess volume in injectable vials and describes when justification is needed for a proposed excess volume in these injectable drug products. This guidance also discusses the importance of appropriate fill volumes for injectable drug products  and recommends that labeled vial fill sizes be appropriate for the intended use and dosing of the  drug product.


 
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						All written comments should be identified with this document's docket number: FDA-2014-D-0248.

                                                                                  Content current as of:
      05/06/2020
         
                  
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