2005P-0411
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC218
  



  

  
Submitter : 
  

  
Mrs. Audrey Good
  

  
Date & Time: 
  

  
01/26/2006 08:01:19
  



  

  
Organization : 
  

  
none
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I am writing in regard to the Wyeth petition (Docket #2005P-0411).  For two years, I have taken bio-identical hormone therapy.  My individualized prescription was the result of consultation, testing and a physical examination by my physician.  It is prepared by a licensed pharmacist.  My physician and pharmacist work together with me to perform additional testing, to consult and to have regularly scheduled physical examinations and follow ups when needed.  As a result of taking this medication, my menopausal symtons which included, severe and frequent hot flashes, fatigue and sleep loss, and mild depression have been alleviated.  The benefit of this theraphy is that is designed for me and I am concerned that Wyeth's petition would limit the ability of my physician and pharmacist to keep prescribing and preparing this medication for me.  I feel that the petition contains incorrect and untruthful information and asked that it be rejected.