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What Can Standardization Do For You?

Wyeth Ayerst has called on the Food and Drug Administration to investigate the sale and marketing of these compounded bio-identical hormones. The complaint doesn't ask the FDA to investigate a specific pharmacy, but to look into what Wyeth claims are illegal practices throughout the industry.  Most of you are aware of this attempt on the part of Big Pharma, in the person of Wyeth, to slow down the tide of customers switching over from their products to compounded bio-identical hormones made by individual compounding pharmacies.

In seeking FDA action, Wyeth says many now also make unsubstantiated “marketing” claims due to the volume of BHRT being made. At this moment in time, pharmacies are regulated by state laws, so the FDA doesn't have jurisdiction over their actions. But drug makers like Wyeth say U.S. compounding pharmacies, thanks to the results of the Women’s Health Initiative, are now mass-producing hormones for women -- essentially acting like drug manufacturers -- and so should be subject to the same rules and scrutiny of the FDA.

It is in all of our best interests, women and pharmacists alike, that the ability to continue to compound bio-identical hormones stays in the hands of the public.
We would like to invite you to get ahead of the curve and join us in making sure every line, on every syringe, in every package with the Wiley® name on it has exactly what the label says it has every time. It is our aim to prove to the FDA that a compounded bio-identical form of HRT can be reliably reproducible, state to state. By registering to be a Wiley licensed Pharmacy, the methods, materials, pricing and packaging for the Wiley Protocol® all become standardized and you become part of the study to be published on the reproducibility of compounded hormone products, eventually a clinical study of a reliable, safe, effective BHRT.

 
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Dana Nelson
Dana Nelson, BS, MS, FASCP
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