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 : 
  

  
EC31
  



  

  
Submitter : 
  

  
Mrs. Karen Zeiger
  

  
Date & Time: 
  

  
09/01/2005 04:09:23
  



  

  
Organization : 
  

  
Mrs. Karen Zeiger
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
1
  


  

  



  

  
 A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC drug product?

  


  

  


  

  



  

  
 This should be made readily available as many women don't have a doctor to prescribe this, or they may need this on a weekend. This would prevent so many unwanted pregnancies and abortions. I can't imagine why determining the age would be any more of a problem than it is for alcohol and tobacco