Compounded preparations for humans are not new, unapproved drugs, according to a recent ruling from a federal district court judge in Midland, Texas.

The judge's verbal order from the bench was in response to a lawsuit filed in September 2004 by 10 compounding pharmacies against the Food and Drug Administration.

Two other issues in the case—FDA's broad authority to inspect pharmacies' records, and the ability of pharmacies to compound from bulk active ingredients for non-food-producing animals—are still being considered by the judge.