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 : 
  

  
EC5
  



  

  
Submitter : 
  

  
Miss. LAURA CUNNINGHAM
  

  
Date & Time: 
  

  
08/29/2005 12:08:38
  



  

  
Organization : 
  

  
Miss. LAURA CUNNINGHAM
  



  

  
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?

  


  

  


  

  



  

  
YES
  


  

  



  

  
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?

  


  

  


  

  



  

  
YES
  


  

  


  

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


  

  



  

  
YES
  


  

  



  

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


  

  



  

  
YES
  


  

  


  

  
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, BY MAKING STORES CHECK IDENTIFICATION BEFORE PURCHASE, JUST AS THEY DO WITH CIGARETTES AND ALCOLHOL. CASH REGESTERS AUTOMATICALLY STOP A SALE AND ASK FOR THE CUSTOMERS DATE OF BIRTH. PUTTING THEM BEHIND A PHARMACY COUNTER WOULD MAKE THEM AS INACESSABLE THEY WERE BEFORE BECAUSE PHARMACISTS WOULD THEN NOT DISTRIBUTE THEM DUE TO RELIGIOUS BELIFES.

  


  

  


  

  


  

  


  

  



  

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


  

  








  

  
 BY MAKING CASH REGISTERS CHECK DATE OF BIRTH



  


  

  


  

  


  

  
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?

  


  

  


  

  



  

  
YES,WITH A DISCLOSURE
  


  

  



  

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


  

  



  

  
 IF THERE WAS A DIFFERENCE IN PRODUCT INGREDIENTS



  


  

  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
PUT THIS PRODUCT ON THE SHELF SO WOMEN MAY DECIDE FOR THEMSEVES WHAT IS RIGHT FOR THEM.