2005P-0411 | Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs | |||||||||||||||||||||||
FDA Comment Number : | EC7315 | |||||||||||||||||||||||
Submitter : | Mrs. Nancy Tuttle | Date & Time: | 03/06/2006 02:03:29 | |||||||||||||||||||||
Organization : | Mrs. Nancy Tuttle | |||||||||||||||||||||||
Category : | Drug Association | |||||||||||||||||||||||
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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 Nancy Tuttle and I have been taking bio-identical hormones for 6 months. It has been a tremendous comfort to me as it alleviates a hormonal issue I had for over 2 years where other medications that had been prescribed by another physician, did not help. I consulted my physician, who prescribes bio-identical hormones specifically for me, and my pharmacist prepares them. Without this medication, I would have to continue to endure the pain that this medication eliminates. 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, Nancy Tuttle Lansdowne,PA | ||||||||||||||||||||||||