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          Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling RecommendationsSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations
		 
			Draft Guidance for Industry
		
		June 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	Download the  Draft  Guidance Document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	  	    Not for implementation.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-0391
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research
          Center for Devices and Radiological Health


This guidance provides recommendations regarding in vitro testing of oral drug products, other than solutions, administered via enteral feeding tube (hereinafter enteral tube). These products represent a wide range of oral dosage forms including, but not limited to, granules, pellets, powders, suspensions, capsules, and tablets. The recommendations for in vitro testing apply to products that are subject to the following and submitted under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and 21 CFR parts 312 and 314:


 
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						All written comments should be identified with this document's docket number: FDA-2021-D-0391.

                                                                                  Content current as of:
      02/01/2022
         
                  
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