Guidance for Industry 
        ANDAs:  Stability Testing of 
        Drug Substances and Products 
                           
                           
                           
                           
                           
            Questions and Answers 
                           
                           
                           
                           
       
       
       
       
       
       
          
        
                           
                           
                           
                U.S. Department of Health and Human Services 
                   Food and Drug Administration 
               Center for Drug Evaluation and Research (CDER) 
                           
                        May 2014 
                        Generics 
                           
       
                                   
                                   
                                   
           Guidance for Industry 
           ANDAs:  Stability Testing of 
          Drug Substances and Products 
                                   
                                   
                                   
                Questions and Answers 
                                   
                                   
                                   
                                   
                                   
                          Additional copies are available from: 
                             Office of Communications 
                       Division of Drug Information, WO51, Room 2201 
                         Center for Drug Evaluation and Research 
                            Food and Drug Administration 
                      10903 New Hampshire Ave., Silver Spring, MD 20993  
                         Phone: 301-796-3400; Fax: 301-847-8714 
                             druginfo@fda.hhs.gov  
               http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm 
                                   
                                   
                                   
                                   
                                   
                                   
                                   
                                   
                                   
                     U.S. Department of Health and Human Services 
                          Food and Drug Administration 
                    Center for Drug Evaluation and Research (CDER) 
                                   
                                May 2014 
                                Generics 
           
         
         
                                                                                            
                                                                                            
                                                                                            
                                                                        TABLE OF CONTENTS 
                       
                       
                       
                      I.        INTRODUCTION............................................................................................................. 1 
                      II.       QUESTIONS AND ANSWERS ....................................................................................... 1 
                         A.     General ............................................................................................................................................ 1 
                         B.     Drug Master File ............................................................................................................................ 5 
                         C.     Drug Product Manufacturing and Packaging ............................................................................. 6 
                         D.     Amendments to Pending ANDA Application ............................................................................ 12 
                         E.     Stability Studies ............................................................................................................................ 13 
                       
                                           Contains Nonbinding Recommendations 
                                               Guidance for Industry1 
                     ANDAs:  Stability Testing of Drug Substances and Products 
                                               Questions and Answers 
                
                
               This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic.  It 
               does not create or confer any rights for or on any person and does not operate to bind FDA or the public.  
               You can use an alternative approach if the approach satisfies the requirements of the applicable statutes 
               and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for 
               implementing this guidance.  If you cannot identify the appropriate FDA staff, call the appropriate 
               number listed on the title page of this guidance.  
                
                
               I.      INTRODUCTION  
                
               This guidance provides answers to questions from the public comments we received on the draft 
               guidance for industry on ANDAs: Stability Testing of Drug Substances and Products2 (FDA 
               stability guidance) that published in the Federal Register of September 25, 2012.  The final 
               guidance for industry of the same title published in the Federal Register of June 20, 2013.  
               Comments received on the draft of this guidance published in the Federal Register of August 27, 
               2013 have also been incorporated.  General issues; drug master files (DMFs); drug product 
               manufacturing and packaging; and stability studies are discussed in this guidance and are 
               intended to clarify the stability testing data recommendations for abbreviated new drug 
               applications (ANDAs).  In this document, the terms drug substance and active pharmaceutical 
               ingredient (API) are used interchangeably. 
                
               FDA’s guidance documents, including this guidance, do not establish legally enforceable 
               responsibilities.  Instead, guidances describe the Agency’s current thinking on a topic and should 
               be viewed only as recommendations, unless specific regulatory or statutory requirements are 
               cited.  The use of the word should in Agency guidances means that something is suggested or 
               recommended, but not required.  
                
               II.     QUESTIONS AND ANSWERS 
                
                       A.     General 
                    
               Q1:   What is the scope of and implementation date for the FDA stability guidance? 
                
                       A1:        The FDA stability guidance covers all new ANDAs under the Federal Food, 
                                  Drug, and Cosmetic Act, section 505 (j), and DMFs (Type II for drug 
                                                                
               1
                 This guidance has been prepared by the Office of Generic Drugs and Office of Pharmaceutical Science in the 
               Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration.                     
               2
                 We update guidances periodically.  To make sure you have the most recent version of a guidance, check the FDA 
               Drugs guidance Web page at 
               http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 
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