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News of the Day ... In Perspective

08/31/2006

FDA 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).

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