FDA Warns Against Bio-Identical Hormone Therapy

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Pharmacies that don't address these violations run the risk of further enforcement, including injunctions and seizure of these drugs. However, the pharmacies can continue to make BHRT compounds as long as they don't contain estriol and don't make false claims, Autor said.

The FDA action isn't intended to target pharmacists who practice traditional pharmacy compounding -- combining or altering drug ingredients for an individual patient in response to a doctor's prescription -- and don't make false or misleading claims about compounded products, Autor said.

The FDA also received a petition from the drug maker Wyeth, of Madison, N.J., which asked the agency to take action against compounding pharmacy operations that produce compounded BHRT drugs. Others who have expressed concerns about these compounds include health-care providers and consumer groups, according to the FDA.

The seven pharmacies are Panorama Compounding Pharmacy of Lake Balboa, Calif.; Saint John's Medical Plaza Pharmacy of Santa Monica, Calif.; Murray Avenue Apothecary of Pittsburgh; Village Compounding Pharmacy of Houston; Pharmacy Compounding Specialties of Dallas; Reed's Compounding Pharmacy of Tucson, Ariz.; and Pacifica Pharmacy of Torrance, Calif.

Dr. Wulf Utian, executive director of the North American Menopause Society, said he supported the FDA's action.

"The FDA has done the right thing, and it's a pity it didn't happen sooner," Utian said. "We have no idea about the risks and benefits of these compounds, because they have not been subjected to the scrutiny the FDA gives to approved hormonal medications.

"If you are on a product that hasn't been FDA approved, you should see your doctor," he added. "If you have a good reason to be on hormones, you should ask to be converted to something that has undergone FDA scrutiny."

If a woman must take hormone replacement therapy to ease the symptoms of menopause, she should take the lowest possible dose for the shortest amount of time, the FDA said.

Phil Pylant, the owner of Village Compounding Pharmacy, said he couldn't figure out why his company was being singled out by the FDA. "I am one of 5,000 to 8,000 compounding pharmacies in the country that's doing the exact same thing -- including CVS and Walgreens -- and they all use the same drugs we use. Why they picked me out, I have no idea."