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          Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug ProductsSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products
					Guidance for Industry
		
		July 2020


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    PrintDocket Number:
		    FDA-2017-D-0829
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research


The last few decades have seen an increasing demand in various health care settings for solid oral dosage form drug products repackaged into unit-dose containers, which hold a quantity of drug for administration as a single dose. The increase in unit-dose repackaging has led to questions regarding stability studies and appropriate expiration dates for these repackaged products. This guidance describes the circumstances under which FDA generally does not intend to take action regarding required stability studies for these repackaged products and appropriate expiration dates under those circumstances.


 
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                                                                                  Content current as of:
      07/29/2020
         
                  
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