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News of the Day ... In Perspective08/31/2006FDA seeks to expand power over compounding pharmacies In a reversal of its long-standing hands-off policy toward compounding pharmacies, the Food and Drug Administration has issued warnings to three compounding firms and threatened additional enforcement action. It contends that custom-blended treatments are new drugs, giving it jurisdiction over pharmacies that sell such products. About 5 percent of U.S. prescription treatments are dispensed by compounding pharmacies. The custom-blended products, made from bulk ingredients, can offer lower doses for children or omit components to which a patient is allergic. One of the more popular products is �Tri-Est,� which combines three estrogens and progesterone. Through a citizens� petition, Wyeth is trying to stop the marketing of compounded preparations as safer than its FDA-approved hormone products. Wyeth is now defending itself against a lawsuit charging that its products increase cancer risk. The American College of Obstetrics and Gynecology is siding with Wyeth. Meanwhile, 10 pharmacists have argued in a Texas federal court that the FDA is wrong to treat compounded products as unapproved new drugs. A decision favorable to the pharmacists would have ripple effects across the nation. The FDA is �simply in denial right now� about compounding, stated Terry Scarborough, who represents the pharmacists (Dietra Henderson, Boston Globe 8/29/06). Additional information:
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