Cheryle R. Hart, M.D. Clarifies Previous Statement on 1/11/08
SPOKANE, Wash., Jan. 16 /PRNewswire/ -- On January 9, 2008 the FDA raised the issue regarding the use of estriol in compounded hormone replacement therapy. While awaiting further clarification, Dr. Hart suspended prescribing estriol in her medical practice. Cheryle Hart, M.D. is Mayo Clinic trained and Board certified in Ob/Gyn and founded what is now Hormones by Hart in 1997. She is also the medical director of Hormones by Hart.
Dr. Hart has been discussing this issue with medical experts in hormone replacement therapy and with some of the most experienced compounding pharmacies across the U.S. "I have learned that compounded hormone prescriptions containing estriol have been and continue to be prescribed as an important part of Hormone Replacement Therapy (HRT) throughout the United States," says Dr. Hart. The continuation of such compounding remains the subject of a major dispute between compounding pharmacies and the FDA.
The International Academy of Compounding Pharmacists (IACP) -- who represents thousands of compounding pharmacies -- says that the situation with estriol is comparable to many commonly prescribed drugs. While estriol was never formally approved by the FDA, it has a monograph from the U.S. Pharmacopeia (USP) prior to 1997. When Congress passed the FDA Modernization Act in 1997, Congress clearly indicated that drugs with a USP monograph could still be compounded when prescribed by a licensed medical practitioner.
"With this new information and clarification from the IACP, I am updating my previous intentions about prescribing compounds containing estriol," says Dr. Hart. "Until the courts give us the final word on this subject, I will continue to prescribe estriol as an important part of the total hormone replacement therapy for my patients -- whom I have found to benefit from its use. I want my patients to know that all of their prescription hormones are still going to be available," promises Cheryle R. Hart, M.D.
If you would like to let the FDA know how you feel, please go to their comment website at: http://www.fda.gov/cder/comment.htm
IACP Reply to FDA News on BHRT: http://www.iacprx.org/
Statement From The American Pharmacists Association Regarding FDA's
Original FDA News Release January 9, 2008: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01772.html
|SOURCE Cheryle R. Hart, M.D.|
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