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 : 
  

  
EC13
  



  

  
Submitter : 
  

  
Mr. Alexander Clague
  

  
Date & Time: 
  

  
09/01/2005 04:09:27
  



  

  
Organization : 
  

  
Mr. Alexander Clague
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
2
  


  

  



  

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


  

  



  

  
 There are two obvious circumstances where products are limited for purchase on the basis of age:  alcohol and tobacco.  If a pharmaceutical product were to be sold based on age-related criteria, similar protocols from what are in existence today should suffice to ensure compliance with the laws. In addition, since Plan B is not habit forming, the way alcohol & tobacco products are, some of the restrictions on advertising which exist for tobacco would not be necessary in the case of 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?

  


  

  


  

  



  

  
 This is an odd question, since omeprazole (brand name Prilosec) is currently being sold both as a prescription and as an OTC product. The distinction that the OTC product is a different salt than the prescription product has no biologic significance.  Accordingly, the same package may be used so long as the "OTC" product contains whatever required language the "prescription" product would require so that there would not be any problems where a pharmacy were "out of stock" of the prescription product while still having an  inventory of the OTC product.

  


  

  


  

  


  

  


  

  



  

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


  

  



  

  
only if the "package insert" information is not available for the "prescription" sale.
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Plan B is safe and should be sold over the counter.  If young girls are required to obtain a prescription for it, the packaging should be created to ensure flexibility regarding the type of sale so that there are no inventory "shortages" for either the OTC or prescription sale.