U.S. flag
        An official website of the United States government
          Here’s how you know
        Here's how you knowDot gov**The .gov means it’s official.**
              
              Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.
        Https**The site is secure.**
              
              The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.  *U.S. Dept. of Health & Human Services
        Guidance Portal*
Menu


    close

        
        
                      

          
                      Enter the terms you wish to search for.
    Search Return to Search
      Chapter 4 - Human Drugs
              Final
      
          
      **Issued by:**  Food and Drug Administration (FDA)

      
      
                                      

      
      **DISCLAIMER:** The contents of this database lack the force and effect of law, except as
          authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically
          incorporated into a contract.  The Department may not cite, use, or rely on any guidance that is not posted
          on the guidance repository, except to establish historical facts.      
              Unique ID: HHS-0910--F-2298Date Published: 5/29/2020
      < Return to Search Return to top



      Connect with Us
            
            Sign Up for Email Updates
						  To sign up for updates or to access your subscriber preferences, please enter your contact information below.
              Email

            HHS Guidance Repository
						  A federal government website managed by the
						  U.S. Department of Health & Human Services
              200 Independence Avenue, S.W.
						  Washington, D.C. 20201
						  Toll Free Call Center: 1-877-696-6775​
  


      Column 1
            HHS.gov
                              
                    
      
              Contact HHS
                              
                    
      
              Careers
                              
                    
      
              HHS FAQs
                              
                    
      
              Column 2
            Nondiscrimination Notice
                              
                    
      
              HHS Archive
                              
                    
      
              Accessibility
                              
                    
      
              Privacy Policy
                              
                    
      
              Column 3
            Viewers & Players
                              
                    
      
              Budget/Performance
                              
                    
      
              Inspector General
                              
                    
      
              EEO/No Fear Act
                              
                    
      
              Column 4
            FOIA
                              
                    
      
              The White House
                              
                    
      
              USA.gov
    
    
  


    
          Column 1
            Español
                              
                    
      
              繁體中文
                              
                    
      
              Tiếng Việt
                              
                    
      
              한국어
                              
                    
      
              Column 2
            Tagalog
                              
                    
      
              Русский
                              
                    
      
              العربية
                              
                    
      
              Kreyòl Ayisyen
                              
                    
      
              Column 3
            Français
                              
                    
      
              Polski
                              
                    
      
              Português
                              
                    
      
              Italiano
                              
                    
      
              Column 4
            Deutsch
                              
                    
      
              日本語
                              
                    
      
              فارسی
                              
                    
      
              English