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Court halts regulators' oversight of DVM drugs
Jefferson City, Mo. - A Missouri Supreme Court ruling that exempts the retail sale of prescription veterinary drugs from the state pharmacy board's oversight has prompted a Senate bill calling for regulatory clarification.
JEFFERSON CITY, MO. — A Missouri Supreme Court ruling that exempts the retail sale of prescription veterinary drugs from the state pharmacy board's oversight has prompted a Senate bill calling for regulatory clarification.
The measure, listed as SB 195, modifies Missouri law relating to the licenses of pharmacists and adds, among other things, language to include veterinary prescriptions in the state's pharmacy practice definition.
Current law fails to specifically mention veterinary drugs, and according to experts, such ambiguity is not unique to Missouri's pharmacy act. Yet, unlike other states, the loophole prompted a long legal battle between feed retailer United Pharmacal Co. of Missouri Inc. and the Missouri Board of Pharmacy. In December, the state Supreme Court justices ruled in favor of the retailer, which had filled prescriptions for veterinary legend drugs without a pharmacy license for decades.
Chief Justice Michael A. Wolff's opinion, echoing a 7-0 ruling, states the law fails to give the pharmacy board regulatory authority over the retail sale of drugs designed to treat animals. The decision reverses a lower court ruling that found the store's activities amounted to practicing pharmacy without a license, a felony punishable by fines and jail time.
Tammy Siebert, executive assistant with the Missouri Board of Pharmacy did not return repeated DVM Newsmagazine calls seeking comment. Debra Ringgenberg is expected to fill the board's executive director seat, vacant at presstime. She could not be reached.
But Greg Dennis, legal counsel for the Missouri Veterinary Medical Association (MVMA), expects state officials to request a rehearing. For now, no state agency holds jurisdiction over veterinary legend drugs — an outcome that could spread if the Supreme Court ruling is used as persuasive authority in other states.
"Most state pharmacy practice acts are really written with human medicine in mind," Dennis says. "So when it comes to animal drugs, there's no real authority. I wouldn't be surprised to hear about other lawsuits filed in other states."
Veterinary medicine reacts
No copycat lawsuits surfaced at presstime, according to legal and regulatory watchdogs within the American Veterinary Medical Association.
Still, Richard Antweiler, MVMA executive director, wants to keep the authority gap under wraps. According to the Federal Food, Drug and Cosmetic Act, a legend drug is any product that's label requires a prescription for distribution or sale. Since the court's verdict, the pharmacy board holds no power to come down on distributors selling antibiotics, vaccines and other non-scheduled veterinary drugs without prescriptions.
"This is not something we're advertising, but naturally, there's a lot of interest," Antweiler says. "Right now, no one is regulating. I wish I could tell you exactly what that means for veterinarians, but all I can say is we definitely support any measure that codifies what has always been practiced. We're trying to get back the pharmacy board's authority."
PetMed Express angle
Fallout from that lack of authority has Dennis concerned. If the board holds no power to control the distribution of veterinary legend drugs, years of regulatory sanctions might be invalid and lead the nation's largest online veterinary drug distributor to dispute its probation.
PetMed Express, dogged for years by pharmacy boards across the country, has settled regulatory sanctions via fines and probation for alleged drug-distribution violations. In Missouri, the Florida-based company operates within provisional limits that end in April.
Chief Executive Officer Menderes Akdag did not respond to DVM Newsmagazine comment requests, but Dennis expects the probation could be challenged.
"If so, they might be right," he says. "It might not be valid."