Compounded Medicines Legal, Federal Judge Rules

Law360, New York (September 1, 2006, 12:00 AM EDT) -- A federal judge ruled Wednesday that compounded drugs are legal, despite objections from the U.S. Food and Drug Administration.

In his opinion, Judge Robert Junell of the U.S. District Court in Midland, Texas, wrote that combining, mixing and altering ingredients serves a purpose when a commercially available drug is unavailable or when it contains ingredients to which a patient is allergic.

“If compounded drugs were required to undergo the new drug approval process, the result would be that patients needing individually tailored prescriptions would not be...
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