• Defective Drug Side Effects

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The U.S. Food and Drug Administration, who once turned an eye from custom drug blending, now pledges to take a harder look at how pharmacists compound bulk ingredients.

Compounding pharmacies where various ingredients are blended to create custom treatments based on doctors'' specifications, make up 5 percent of the country''s prescription drug dispensation. Custom blending may omit ingredients a patient may be allergic to or provide lower doses for children.

The FDA has quietly disregarded the practice of compounding until now. Last month, the agency issued letters to three different compounding firms warning them of the stricter enforcement action.

The FDA argues that custom blended therapies are new drugs that have not been approved, therefore the regulatory agency has jurisdiction over the compounding pharmacies that sell the products.

Furthermore, the FDA contends that compounded treatments should no longer be marketed or sold as safer alternatives to drugs that have been approved.

Wyeth spokeswoman Candace Steele said the drug company, who is seeking stricter federal regulation of blended drug warning labels, is concerned about patients'' health. Particularly women who are given custom blended hormone replacement therapies without the adequate warnings that are provided on FDA-approved drugs.

“We''re concerned that women are not being provided the warning information that is associated with these agents,” Steele said. “If they don''t receive that information, it''s implied it is safe.”

Dr. Isaac Schiff, chair of the American College of Obstetricians and Gynecologists task force on HRT drugs, said he usually denies women''s request for blended hormone replacement therapies. “With the commercially available products, I know much more about the risks, the side effects, and the quality of the product,” he said.