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 : 
  

  
EC45
  



  

  
Submitter : 
  

  
Mrs. Theresa Lohman
  

  
Date & Time: 
  

  
09/01/2005 04:09:33
  



  

  
Organization : 
  

  
Planned Parenthood
  



  

  
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?

  


  

  


  

  



  

  
Possibly if the consumer had to ask for it (at the pharmacy counter) and show picture ID to purchase it.
  


  

  



  

  
B. If it could, would it be able to do so as practical matter and, if so, how?
  


  

  



  

  
See above