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 : 
  

  
EC22
  



  

  
Submitter : 
  

  
Mr. A. A.  Rankis
  

  
Date & Time: 
  

  
09/01/2005 04:09:00
  



  

  
Organization : 
  

  
Mr. A. A.  Rankis
  



  

  
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?

  


  

  


  

  



  

  
No, Current situation is fine
  


  

  



  

  
1.
  


  

  



  

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

  


  

  


  

  



  

  
No, Current situation is fine
  


  

  


  

  
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
  


  

  



  

  
No, Current situation is fine
  


  

  



  

  
C. If so, would a rulemaking on this issue help dispet that confusion?
  


  

  



  

  
No, Current situation is fine
  


  

  


  

  
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?

  


  

  


  

  


  

  
No, the use of the product would be abused
  


  

  



  

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


  

  



  

  
No, the use of the product would be abused
  


  

  



  

  
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?

  


  

  


  

  



  

  
no
  


  

  


  

  
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
  


  

  



  

  
none
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
If a drug is indeed for "emergency contraception", there appears no way to control or enforce it's use in emergencies only