2005P-0411
  

  
 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC2473
  



  

  
Submitter : 
  

  
Ms. Martha Kokajko
  

  
Date & Time: 
  

  
02/15/2006 04:02:35
  



  

  
Organization : 
  

  
Ms. Martha Kokajko
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Bio-identical hormones offer  safe management of hormone balance and are designed to replace only what the individual's lab results indicate. Compounding pharmacies practice an individualized approach to balancing hormones. This is safe, responsible and far superior to the one-size fits all approach offered through pharmaceuticals. HRT products have been implicated in increased incidents of breast cancer and heart problems. Pharmaceutical companies need to engage in practices that put the public first.  This means looking honestly at the studies and praising compounding pharmacies for following safe, responsible medicine.