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          Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License ApplicationSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application
					Guidance for Industry
		
		January 2018


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This guidance sets forth FDA’s policy regarding the mixing,diluting, and repackagingof certain types of biological products that have been licensed under section 351 of the Public Health Service Act (PHS Act) when such activities are not within the scope of the product’s approved biologics license application (BLA) as described in the approved labeling for the product.


 
	Submit Comments
	   		  			  			Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
						If unable to submit comments online, please mail written comments to:
						Dockets Management
							Food and Drug Administration
							5630 Fishers Lane, Rm 1061
							Rockville, MD 20852
						All comments should be identified with the title of the guidance.

                                                                                  Content current as of:
      05/09/2018
         
                  
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