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A federal district court in Midland, Tex, told the FDA to back away from its controversial efforts to restrict pharmacy's right to compound drugs. The decision makes it clear that compounded preparations are not new, unapproved drugs subject to FDA regulation. It "spares drug-compounding pharmacies from having to meet strict FDA regulations on drug safety and efficacy before they can market their products," according to the International Academy of Compounding Pharmacists (IACP).
Describing the court's action as a "landmark" decision, IACP Executive Director L.D. King said that the ruling stops "FDA's encroachment on the authority of state boards of pharmacy in its tracks, and it ensures that patients and physicians will continue to have access to compounded medicines on which they rely."