2005P-0411
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC7476
  



  

  
Submitter : 
  

  
Mrs. Tina Pachniak
  

  
Date & Time: 
  

  
03/06/2006 04:03:23
  



  

  
Organization : 
  

  
Mrs. Tina Pachniak
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Dear Sir or Madam:

My name is Tina Pachniak, and I have been taking bio-identical hormones for 1 year.  It has been a wonderful tool in my health care options. After determining the cause of my health related problems, my physician prescribed bio-identical hormones specifically for me, and a compounding pharmacy prepares them.  This medication is important to me as it has helped alleviate health related problems without the added ingredients that other prescriptions have.  Since I have multiple food sensitivities and a very sensitive system, these compounded prescriptions are very important to me.  Without these, I would either have to go without, which would cause me to become sick again, or take a prescription that would cause me to be sick. 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 the paharmacist to keep prescribing and preparing these individualized doses for me.  The FDA should reject Wyeth's petition.   Sincerely, Tina Pachniak  Janesville, WI