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 : 
  

  
EC12
  



  

  
Submitter : 
  

  
Dr. Charles Reynolds
  

  
Date & Time: 
  

  
09/01/2005 04:09:08
  



  

  
Organization : 
  

  
UCLA Medical Center, Dept of Pharm Serv
  



  

  
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, this is an important decision for the future of health care in the US.
  


  

  



  

  
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, this is an important decision for the future of health care in the US.
  


  

  


  

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


  

  



  

  
 The issue is not one of confusion. The question becomes one of establishing defined criteria for which a drug may be used and marketed both OTC and Rx.

  


  

  


  

  



  

  
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?

  


  

  


  

  



  

  
Unknown if the FDA has the ability to regulate this under its jurisdiction.
  


  

  


  

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


  

  



  

  
 Yes. By creating a class of drugs that can be directly sold only by a licensed pharmacist. This makes a specific person responsible for effectively implementing what the FDA wants. It also protects the health and safety of US citizens by making them interact with a health care professional who can assess the request for appropriateness as well as potential problems.

  


  

  


  

  


  

  



  

  
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?
  


  

  



  

  
Assuming there is no specific legal prevention, this would be acceptable.
  


  

  



  

  
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 problems, unless regulatory action would require special record keeping to separate OTC use from Rx use... then separate packaging (and thus NDC code) would be important.

  


  

  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
This question, prompted by 'Plan B' product will become more prominent as time goes on unless the US deals with its health care crisis.