FDA cracks down on pharmacies that compound bioidentical hormones

January 10, 2008

FDA warns seven pharmacies that the claims they have made for their bioidentical hormones are unsupported.

Seven compounding pharmacies have received a warning letter from FDA regarding the claims they have made for the bioidentical hormone replacement therapy (BHRT) they prepare. FDA said their claims of safety and effectiveness are unsupported by medical evidence and are considered false and misleading. The agency added that its action is a response to a citizen petition Wyeth had filed, urging FDA to crack down on compounding pharmacies that provide BHRT. The seven pharmacies are Panorama Compounding Pharmacy in Lake Balboa, Calif.; Saint John's Medical Plaza Pharmacy in Santa Monica, Calif.; Murray Avenue Apothecary in Pittsburgh; Village Compounding Pharmacy in Houston; Pharmacy Compounding Specialties in Dallas; Reed's Compounding Pharmacy in Tucson, Ariz.; and Pacifica Pharmacy in Torrance, Calif. In response to this announcement, the International Academy of Compounding Pharmacies (IACP) said more than 70,000 doctors, patients, and pharmacists have filed comments with FDA opposing Wyeth's petition. "Under this policy, patients will suffer while Wyeth profits," said L.D. King, IACP's executive director.

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