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          Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for IndustrySearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry
		 
			Draft Guidance for Industy
		
		October 2021


	Download the  Draft  Guidance Document
	    
      	      		Read the Federal Register Notice 

    Draft
		
		    		Level 1 Guidance

	  	    Not for implementation. Contains non-binding recommendations.
	  
	  
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    PrintDocket Number:
		    FDA-2021-D-1031
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Veterinary Medicine
          Center for Biologics Evaluation and Research
          Center for Drug Evaluation and Research


The Food and Drug Administration (FDA) is issuing this draft guidance to assist registrants of drug establishments in submitting to FDA reports on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution, as required by section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360(j)(3)), as added by section 3112(e) of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).


 
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						All written comments should be identified with this document's docket number: FDA-2021-D-1031.

                                                                                  Content current as of:
      10/29/2021
         
                  
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