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          Collecting and Providing 702(b) Portions of FDA Official SamplesSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Collecting and Providing 702(b) Portions of FDA Official Samples
		 
			Draft Guidance for Industry
		
		January 2022


	Download the  Draft  Guidance Document
	    
      	      		Read the Federal Register Notice 

    Draft

	  	    Not for implementation. Contains non-binding recommendations.
	  
	  
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    PrintDocket Number:
		    FDA-2021-D-0593
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research
          Center for Veterinary Medicine
          Office of Regulatory Affairs
          Center for Biologics Evaluation and Research
          Center for Food Safety and Applied Nutrition


This draft guidance is intended to assist FDA staff and industry with issues and questions related to the requirements for FDA to collect and provide portions of official samples under section 702(b) of the Federal Food, Drug, & Cosmetic Act (FD&C Act) and its implementing regulation in Title 21 Code of Federal Regulations (CFR) section 2.10 (21 CFR 2.10).  The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.


 
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						All written comments should be identified with this document's docket number: FDA-2021-D-0593.

                                                                                  Content current as of:
      01/21/2022
         
                  
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