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Patients, Doctors, Pharmacists Praise Bipartisan House Resolution on Compounded Hormones Containing Estriol
Date:5/7/2008

o Wyeth," continued Mr. King. "Removing this drug from the market robs patients of a long-standing, vital and legal menopause treatment alternative to Wyeth's products. FDA's policy is an unwelcome intrusion of federal bureaucrats into thousands of doctors' offices."

Compounded hormones containing estriol are lawfully prescribed, prepared and dispensed in all 50 states and their use is accepted by the United States Pharmacopeia and the Pharmacy Compounding Accreditation Board. The FDA has acknowledged that it is unaware of any adverse events associated with the use of these drugs. Estriol is a component of a multiple sclerosis treatment undergoing Phase II clinical trials; in compounded form it is prescribed by doctors to treat both multiple sclerosis and symptoms of menopause.

Since FDA announced its estriol policy in January, the agency has since attempted to allay the concerns of thousands of women by stating that doctors may prescribe compounded hormones containing estriol if they complete an Investigational New Drug Application (IND). Unfortunately, this process is unworkable.

"FDA is trying to fit a square peg in a round hole," concluded Mr. King. "FDA is setting doctors up to fail, leaving them in the same position are they are in now -- unable to treat women with the medication of their choice."

Pharmacy compounding is a long-standing, state-regulated and medically vital practice. Millions of Americans have unique health needs that off-the-shelf prescription medications cannot meet. For them, customized, compounded medications -- prescribed or ordered by licensed physicians or veterinarians and mixed safely by trained, licensed compounding pharmacists -- are the only way to better health.

About IACP

The International Academy of Compounding Pharmacists (IACP) is a non-profit association founded in 1991 to protect and promote the art and skill of the compounding pharmacy profession. We represent more than 2
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SOURCE The International Academy of Compounding Pharmacists(IACP)
Copyright©2008 PR Newswire.
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