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          Naming of Drug Products Containing Salt Drug SubstancesSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Naming of Drug Products Containing Salt Drug Substances
					
		
		June 2015


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

    Final

	  
	  
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    PrintDocket Number:
		    FDA-2013-D-1566
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research


This guidance for industry is intended to help you, the sponsor, understand how products with 16 active ingredients that are salts may be affected by CDER’s implementation of the United States 17 Pharmacopeia (USP) policy entitled,Monograph Naming Policy for Salt Drug Substances in18Drug Products and Compounded Preparations2(the USP Salt Policy). Your involvement with 19 the implementation of this policy helps to ensure drug product naming that is consistent with the 20 USP Salt Policy, which became effective on May 1, 2013.


 
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						All written comments should be identified with this document's docket number: FDA-2013-D-1566.

                                                                                  Content current as of:
      08/24/2018
         
                  
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