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          Pharmaceutical Components at Risk for Melamine ContaminationSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Pharmaceutical Components at Risk for Melamine Contamination
					Guidance for Industry
		
		August 2009


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

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    PrintDocket Number:
		    FDA-2009-D-0354
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Veterinary Medicine
          Center for Drug Evaluation and Research


This guidance is intended to alert pharmaceutical manufacturers of finished products, pharmacy compounders, repackers, and suppliers to the potential risk of melamine contamination in pharmaceutical components. In September 2008, FDA received reports from China about food articles contaminated with melamine, which have resulted in thousands of hospitalizations for kidney problems and at least three deaths. As of the date of this guidance, FDA is not aware of any pharmaceuticals that have been contaminated with melamine. However, because of the potential risk of drug contamination, it is important that manufacturers take steps to ensure that susceptible components are not contaminated with melamine.


 
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						All written comments should be identified with this document's docket number: FDA-2009-D-0354.

                                                                                  Content current as of:
      08/24/2018
         
                  
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