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 : 
  

  
EC7
  



  

  
Submitter : 
  

  
Ms. Jennifer Dawson
  

  
Date & Time: 
  

  
08/29/2005 12:08:58
  



  

  
Organization : 
  

  
Ms. Jennifer Dawson
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
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?

  


  

  


  

  



  

  
 Yes, the limitation would be easily enforceable.  Such limitations already exist for medicines like nicotine-replacement therapy, as well as for other controlled substances such as tobacco and alcohol.

  


  

  


  

  


  

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


  

  



  

  
 Pharmacists could be required to check IDs for customers.  If pharmacists can be trusted with dispensing addictive and potentially dangerous pharmaceuticals, clearly they can be trusted to check to ensure customers are of legal age.  If there was concern that pharmacists were not carding customers, undercover operations could be used as they are with tobacco and alcohol, and fines could be levied.

  


  

  


  

  


  

  


  

  
3
  


  

  



  

  
 A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

  


  

  


  

  



  

  
I see no problem with selling prescription and OTC medicines in the same package, so long as their distribution is controlled.
  


  

  



  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I hope that the FDA rules promptly on this issue.  American women have been waiting too long for emergency contraception, which is clearly safe and effective, to be on drugstore shelves.