2005P-0411
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC2526
  



  

  
Submitter : 
  

  
Ms. Karen Hamburg
  

  
Date & Time: 
  

  
02/15/2006 04:02:42
  



  

  
Organization : 
  

  
Ms. Karen Hamburg
  



  

  
Category : 
  

  
Drug Industry
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Division of Dockets Management

Food and Drug Administration

5630 Fishers Lane, Room 1061 (HFA-305)

Rockville, MD, 20852  



RE: Docket 2005P-0411



Dear Sir or Madam:



I have been taking bioidentical hormones. I consult with my physician, who prescribes bio-identical hormones specifically  for me, and my pharmacist prepares them.  

 

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.