Federal court protects mortar and pestle behind compound ruling

Drug Store News,  June 26, 2006  by James Frederick

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MIDLAND, Texas -- The mortar and pestle--the very symbol of community, pharmacy as the tool of compounding-can remain a tool for pharmacy practice, a Texas judge has ruled.

In a landmark victory for pharmacy, U.S. District Judge Robert Junell upheld the longstanding right of pharmacists to customize prescriptions for individual patients. Junell's May 25 ruling means that pharmacists can continue to compound ingredients to create a customized drug, in accordance with a valid prescription.

Junell rejected the Food and Drug Administration's argument that compounding produces new, unapproved drugs that the FDA must approve. He also indicated that he would move to halt the FDA from conducting overly intrusive inspections of compounding pharmacies.

The National Community Pharmacists Association hailed the decision. "As a result of Judge Junell's ruling, patients can rest assured that they will continue to receive the drugs that are necessary to treat their individual conditions," said NCPA executive vice president and CEO Bruce Roberts. "Doctors can write customized prescriptions with the confidence that those drugs will be dispensed according to their exact directions. And pharmacists can continue to serve the public, as they have done for decades, with the clear understanding that they are operating fully within the law."

The judge's decision came in response to a suit, Medical Center Pharmacy et al. v. Gonzales et. al., filed in September 2004 by 10 compounding pharmacies known as the Midland Coalition. Attorneys from Hance, Scarborough, Wright, Woodward & Weisbart, an Austin, Texas, law firm, argued the case for the Coalition.

Still unresolved are questions regarding the right of pharmacists to compound drugs from bulk ingredients for non-food-producing animals such as pets. Nevertheless, said Roberts, "This landmark ruling has national implications and, while it's a victory for doctors and pharmacists, the real winners are the millions of patients who rely on customized pharmaceuticals, to live normal, active, healthy lives."

JAMES FREDERICK

CATEGORY SPECIALIST

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