US court ruling on drug compounding

4 June 2006

A US federal district court judge in Midland, Texas, has ruled that compounded preparations by pharmacies are not new, unapproved drugs.

"This landmark ruling stops the Food and Drug Administration'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," said the executive director of the International Academy of Compounding Pharmacists. He added that, for years, the FDA has told pharmacists that what they were doing - compounding drugs to fill doctors' prescriptions - was illegal. This ruling lifts the veil of uncertainty from pharmacy compounding.

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