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 : 
  

  
EC823
  



  

  
Submitter : 
  

  
Ms. Kay Ropp
  

  
Date & Time: 
  

  
10/13/2005 10:10:14
  



  

  
Organization : 
  

  
Ms. Kay Ropp
  



  

  
Category : 
  

  
Health Professional
  



  

  
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, look at Diphenhydramine.
  


  

  



  

  
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?
  


  

  



  

  
Some confusion, but not significant.
  


  

  



  

  
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
  


  

  



  

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


  

  



  

  
 Make Plan B in the same class as a Class V Controlled Substance.  It's not a drug of abuse, but that way it would be readily available without a prescription, but yet not to anyone below 18.  The FDA might have to invent a new class, say Class VI of the Controlled Substance Act.  The buyer would just have to present ID, etc. Plan B therefore could be both OTC and Rx.   I'm just kicking this idea around, but maybe to prevent

  


  

  


  

  


  

  








  

  
statutory rape, sales could be limited to females only.  I'm a female pharmacist with professional experiences concerning Plan B.
  


  

  



  

  
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.  Look at Novahistine DH and Exp as examples; just some quantity limits (4 oz vs 16 oz).
  


  

  


  

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


  

  



  

  
Can't think of any right now.
  


  

  



  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
Consider Plan B in Class V of Controlled Substance Act or in my new proposed Class VI.