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          Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic StockpilesSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles 
					Guidance for Government Public Health and Emergency Response Stakeholders
		
		April 2019


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    PrintDocket Number:
		    2019-08349
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research


A number of government public health and emergency response stakeholders2 maintain stockpiles of doxycycline3 tablets or capsules for post-exposure prophylaxis (PEP) or treatment of inhalational anthrax in the event of an anthrax emergency. States have asked FDA what would be necessary to provide confidence that stockpiled doxycycline tablets and capsules have retained their original quality (i.e., purity and potency) beyond the manufacturer’s labeled expiration date so the replacement of stockpiled product could be deferred.4

This document provides guidance to government stakeholders on testing to extend the expiration date—under section 564A(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act5—of stockpiled doxycycline tablets and capsules for public health emergency preparedness and response purposes for an anthrax emergency.


 
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                                                                                  Content current as of:
      04/24/2019
         
                  
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