News

Judge Issues Landmark Decision in Compounding Pharmacy Case

Friday, May 26, 2006

Midland, Texas

Yesterday, in Midland, Texas, Federal District Judge Robert Junell ruled from the bench the following order, "The Court finds that the compounding of ingredients to create a drug pursuant to valid prescription from a health care provider does not create a new drug." This ruling means that compounded preparations are legal and therefore not subject to the requirements and prohibitions imposed upon such drugs under the 1938 Food, Drug and Cosmetic Act. Judge Junell's additional statements indicate that he appears to be poised to provide injunctive relief for the plaintiffs.

Judge Junell's decision came in the lawsuit styled, Medical Center Pharmacy, et al v. Gonzales, et al., initially filed on September 27, 2004 by ten (10) compounding pharmacies, known as the Midland Coalition, against the Food and Drug Administration (FDA). Judge Junell informed the plaintiffs that his rulings would be binding only after he had written and signed his decision, which will probably be issued in late July.

The Midland Coalition filed suit against the FDA charging that the FDA had exceeded its jurisdiction and was illegally intervening into the practice of pharmacy. Pharmacies have historically been regulated by their respective state boards of pharmacy, not the FDA. The coalition further charged that the FDA had no legal basis to hold the position that compounded preparations were illegal.

The members of the Midland Coalition are Steve Rogers, RPh, Medical Center Pharmacy, Midland, Texas; Tom Bader, RPh, College Pharmacy, Colorado Springs, Colorado; Pat Downing, RPh., Med Shop Total Care Pharmacy, Longview, Texas; Sam Kelly, Applied Pharmacy, Mobile, Alabama; John Rains, RPh, Plum Creek Pharmacy, Amarillo, Texas; Wally Simons, RPh, Pet Health Pharmacy and Women's International Pharmacy, Phoenix, Arizona and Madison, Wisconsin; Steven Hotze, M.D., Premier Pharmacy, Houston, Texas; John Grasela, RPh, University Compounding Pharmacy, San Diego, California; Steve Organ, Veterinary Pharmacies of America, Houston, Texas. These individuals realized that very existence of compounding pharmacy was being threatened by the actions of the FDA and therefore filed this lawsuit.

The Midland Coalition was represented by the law firm of Hance Scarborough Wright Woodward & Weisbart of Austin, Texas. Terry Scarborough has been the lead attorney in this case and has demonstrated his commanding courtroom presence. He worked in concert with his brilliant associate attorney, Matthew Slimp. Both Scarborough and Slimp performed a yeoman's chore in developing the compelling legal arguments that carried the day. They both made extraordinarily persuasive presentations before Judge Junnel in court yesterday. As a result of this tremendous win, both Scarborough and Slimp have established themselves as authorities in the field of compounding pharmacy law. Terry Scarborough will be speaking at the IACP's Compounders on Capitol Hill in Washington, D.C. on Monday morning, June 5, 2006.

The U.S. Government was ably represented in this case by Gerald Kell, attorney for the Office of Consumer Litigation of the Office of the U.S. Attorney General. Mr. Kell indicated to the court that the FDA would file an appeal of this decision to the 5th Federal District Court of Appeals in New Orleans.