2005N-0345
  

  
 Drug Approvals:  Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product

  


  

  

  


  

  


  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC9
  



  

  
Submitter : 
  

  
Dr. TRACI CORDER
  

  
Date & Time: 
  

  
08/29/2005 12:08:21
  



  

  
Organization : 
  

  
Dr. TRACI CORDER
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
2
  


  

  



  

  
 A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a matter of law?

  


  

  


  

  



  

  
 I feel it is unlawful to with hold certain medications to a subpopulations. They are either safe or they aren't safe. There is no biochemical difference in this subpopulation.