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 : 
  

  
EC35
  



  

  
Submitter : 
  

  
Mrs. Michelle Thornton-Taylor
  

  
Date & Time: 
  

  
09/01/2005 04:09:25
  



  

  
Organization : 
  

  
Mrs. Michelle Thornton-Taylor
  



  

  
Category : 
  

  
Drug Industry
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 In reference to Plan B being made OTC: As parents we are still responsible for our children and what they put into their bodies - therefore I feel that this drug should not be made over the counter. It has a greater potential for abuse than other drugs which have been made over the counter. A way of regulating it could be same as what is done in Florida with control substances (that are in the V category). They are kept in the pharmacy on the pharmacy shelf. Individuals must sign for them, they must produce a photo ID to prove that they are 18 years of age or older and there is a regulation as to how much they can receive at in one time, and in any one time period.