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          Reformulating Drug Products That Contain Carbomers Manufactured With BenzeneSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Reformulating Drug Products That Contain Carbomers Manufactured With Benzene
					
		
		December 2023


	Download the  Final Guidance Document 

    Final
		
		    		Level 1 Guidance

	  
	  
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    PrintDocket Number:
		    FDA-2023-D-5408
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research


The purpose of this guidance is to provide recommendations for applicants and manufacturers on what tests should be performed and what documentation should be submitted or available to FDA to support the reformulation of drug products that use carbomers manufactured with benzene. Certain United States Pharmacopeia (USP) carbomer monographs currently allow for unacceptable levels of benzene, which raises safety concerns. FDA has requested that the USP omit (or remove) these monographs, and applicants and manufacturers may need to reformulate their drug products to avoid using these carbomers. This guidance provides recommendations for testing and documentation related to reformulation, taking into consideration the various routes of administration and dosage forms of affected drug products. For application holders, this guidance also recommends appropriate submission types to notify the Agency of such changes.


 
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						All written comments should be identified with this document's docket number: FDA-2023-D-5408.

                                                                                  Content current as of:
      12/27/2023
         
                  
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