Federal Court Upholds Pharmacists' Ability to Compound Drugs; Landmark Decisiona Victory for Millions of Patients

5 June 2006

The National Community Pharmacists Association (NCPA) today hailed a federal district court ruling in Texas that upholds the ability of pharmacists to customize prescriptions for individual patients.

U.S. District Judge Robert Junell ruled on May 25 that the compounding of ingredients to create a customized drug, in accordance with a valid prescription, does not create a new drug. In issuing the ruling, Junell rejected the Food and Drug Administration's (FDA) argument that compounding produces new, unapproved drugs that the FDA must approve.

"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, RPh. "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 was issued in the Midland, Texas, case, Medical Center Pharmacy et al. v. Gonzales et.al. The suit was 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.

"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," Roberts said. "NCPA applauds Judge Junell for his common sense ruling because it puts the best interests of the public first."

After issuing his verbal order from the bench, Judge Junell indicated he will issue a formal written order in the case later. He also indicated that he is poised to halt the FDA from conducting overly intrusive inspections of compounding pharmacies. Still unresolved in the case are questions regarding the right of pharmacists to compound drugs from bulk ingredients for non-food- producing animals such as pets.

Additional information is available from attorney Terry L. Scarborough, Hance, Scarborough, Wright, Woodward & Weisbart, 111 Congress Ave., Suite 100, Austin, Texas 78701, 512-479-8888 or tscarborough@hswww.com

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The National Community Pharmacists Association (NCPA), founded in 1898, represents the nation's community pharmacists, including the owners of more than 24,000 pharmacies, more than 68,000 pharmacists, and more than 280,000 full-time employees. The nation's independent pharmacies, independent pharmacy franchises, and independent chains represent a $98 billion marketplace and dispense nearly half of the nation's retail prescription medicines.

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