2005P-0411
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC6990
  



  

  
Submitter : 
  

  
Mrs. Janica  McCool
  

  
Date & Time: 
  

  
03/06/2006 09:03:29
  



  

  
Organization : 
  

  
Mrs. Janica  McCool
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 My name is Janica McCool and I have been taking bio-identical hormones for the past 5 years.  Taking bio-identical hormones have been a life- saver to me.  Prior to that I took synthetic hormones that caused me many complications.  I consult with my physician, who prescribes bio- identical hormones specifically 



for me, and my pharmacist prepares them.  Without this medication, I would not enjoy the quality of life that I currently have today.



The benefit of BHRT is that it is designed for me and I am concerned that Wyeth?s petition (Docket # 2005P-0411) would limit the ability of my physician and pharmacist to keep prescribing and preparing these individualized doses for me.  The FDA should reject Wyeth?s petition.



Sincerely, 

Janica McCool