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          Child-Resistant Packaging Statements in Drug Product Labeling Guidance for IndustrySearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Child-Resistant Packaging Statements in Drug Product Labeling Guidance for Industry
					
		
		August 2019


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

    Final
		
		    		Level 1 Guidance

	  
	  
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    PrintDocket Number:
		    FDA-2017-D-2163
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research


This guidance is intended to assist applicants, manufacturers, packagers, and distributors (collectively referred to as firms) who choose to include child-resistant packaging (CRP) statements in their drug product labeling. The guidance discusses what information should be included to support CRP statements in labeling for new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and supplements to these applications. In addition to recommendations for labeling of prescription drug products, this guidance also includes recommendations for labeling both for nonprescription drug products approved under an NDA or ANDA and those that are marketed under the Over-the-Counter (OTC) Drug Review. This guidance is intended to help ensure that such labeling is clear, useful, informative, and, to the extent possible, consistent in content and format.


 
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                                                                                  Content current as of:
      10/23/2019
         
                  
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