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          Drug Master Files for Bulk Antibiotic Drug SubstancesSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Drug Master Files for Bulk Antibiotic Drug Substances
					Guidance for Industry
		
		November 1999


	Download the  Final Guidance Document
	    
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    PrintDocket Number:
		    FDA-1999-D-1314
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research


This guidance is intended for those in industry whose approved applications for bulk antibiotic drug substances (i.e., bulk applications) were converted to Type II Drug Master Files (DMFs) when section 507 of the Federal Food, Drug, and Cosmetic Act was repealed as part of the enactment of section 125 of Title I of the Food and Drug Administration Modernization Act on November 21, 1997. This guidance explains the purpose of DMFs, discusses the type of information expected in a Type II DMF, outlines administrative procedures governing review of DMFs, and clarifies your responsibilities as a DMF holder. The information presented in this guidance is also relevant to the submission of new DMFs for bulk antibiotic drug substances.


 
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						All written comments should be identified with this document's docket number: FDA-1999-D-1314.

                                                                                  Content current as of:
      02/22/2018
         
                  
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