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Ruling hurts FDA push on compounds

Judge: Practice doesn't create new drugs so isn't under agency's purview

WASHINGTON -- Pharmacists who custom-blend drugs from bulk ingredients based on a doctor's prescription do not create new unapproved drugs, a federal judge in Texas said, undercutting the Food and Drug Administration's attempts to regulate the practice, known as compounding.

US District Judge Robert Junell's ruling upheld many of the claims made by 10 compounding pharmacists who said FDA enforcement agents overstepped the agency's jurisdiction by attempting to inspect the records of pharmacists in good standing with state regulators. Legislation passed by Congress that exempts compounding pharmacies from such detailed FDA inspections ``demonstrates Congress's intent to carve out a niche for compounded drugs," he said.

The ruling said that unless pharmacies disobey local laws or dispense compounded drugs without a doctor's prescription written for an individual patient, the FDA can only conduct ``limited" inspections of such items as equipment, materials, and labels.

Terry L. Scarborough, the attorney who argued the case on behalf of the pharmacists, said that because of the federal government's ``aggressive" defense of the matter, the ruling will likely have nationwide impact.

The FDA has shown the most interest in compounding pharmacies that prepare drugs in large volume . In warning letters to firms it alleged they used compounding as a ruse for the mass production of prescription treatments.

Scarborough said he expects the FDA to appeal Junell's ruling, which was released yesterday, and that the case could go to the Supreme Court.

FDA spokeswoman Susan Cruzan said the agency ``will consider all options, including seeking an appeal."

Through compounding, pharmacists can mix drugs at lower doses better tolerated by children or omit an ingredient to which a patient is allergic. State pharmacy boards already regulate compounding pharmacies ; the FDA had argued it also had jurisdiction by alleging the compounded medicines are new drugs . Forcing compounded drugs to go through the FDA's time-consuming new drug approval process would deprive patients of ``individually tailored prescriptions" their doctors endorse, Junell wrote, in ruling for the pharmacists. ``It is not feasible, either economically or timewise, for the needed medications to be subject to the FDA approval process."

He also ruled that it is legal for pharmacists to compound drugs to treat some animals . The FDA's policy currently treats such compounded veterinary medications as illegal.

An association that represents compounding pharmacists applauded the Texas court's decision in the case.

``The court's ruling is a precedent-setting victory for millions of patients, their doctors who prescribe compounded medicines for them, and the compounding pharmacists," L.D. King , executive director of the International Academy of Compounding Pharmacists , said in a statement. ``This ruling affirms what the rest of the government and medical establishment have long held: Compounding is vital and it is legal."

Diedtra Henderson can be reached atdhenderson@globe.com.

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