2005P-0411
  

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

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC6984
  



  

  
Submitter : 
  

  
Dr. MJ Zank
  

  
Date & Time: 
  

  
03/06/2006 09:03:33
  



  

  
Organization : 
  

  
Dr. MJ Zank
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 



VIA FAX: (301) 827-6870



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:



 My name is MJ Zank_____________ and I have been taking bio-

              (name)

identical hormones for _2 years_.  It has been a tremendous comfort to me as it 

                                          (length of time)

alleviates menopausal symptoms.

                          (symptoms)

 

I consult with my physician, who prescribes bio-identical hormones specifically 



for me, and my pharmacist prepares them.  Without this medication, ____________ 



I would find life extremely difficult

____________________________________________________________



___________________________________________________________.

(Describe how you would suffer or how your life would be more difficult without the medication.)

 

 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,





MJ Zank

________________________________

 (Name)



________Ada__________________, _________OH_______

 (City) (State)