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Landmark Compounding Court Decision Issued
Posted on by Paula Gallagher
In 2009, a pharmacy owned by Paul Franck made a mistake compounding a medication for horses and unfortunately, 21 polo horses died. After this happened, Franck’s pharmacy launched a recall, did an investigation, determined the weakness, and modified their policies and procedures dramatically to prevent similar errors from ever happening again.
The FDA sued the pharmacy because they feel that pharmacies should not compound and if they do compound for animals, they must not use bulk powders, but instead crush tablets necessary for the medication (which results in a gritty, less absorbable medication).
Last week the verdict was in and Paul Franck won. Here is the official press release.
On September 12, 2011, Judge Timothy Corrigan of the US District Court for the Middle District of Florida issued his ruling in US v. Franck's Lab, Inc. This lawsuit, brought by the Food & Drug Administration against IACP/PCCA member Paul Franck and his pharmacy, alleged that the use of active pharmaceutical ingredients (APIs) in compounding veterinary preparations for non-food producing animals was illegal. The FDA stated in its case that Franck's Lab, Inc. and all other pharmacists involved in compounding veterinary preparations with APIs were in direct violation of AMDUCA, the FDA's CPG, and the entire Food Drug and Cosmetic Act because those preparations are "new drugs" and subject to FDA review and approval.
The FDA lost.
Paul Franck and compounding pharmacy were victorious!
The ruling is a huge "win" for compounders. Not only does it clearly refute the FDA's attempts to exert unauthorized jurisdiction over compounding, it is sharply critical of the FDA's approach towards veterinary compounding in particular.
"Not only did Judge Corrigan correctly rule that Congress never intended the FDA to prohibit the use of APIs in veterinary compounding, he also clearly stated what IACP has said for years the FDA does not have jurisdiction over the traditional practice of pharmacy compounding. That is the sole authority of the state Boards of Pharmacy," said IACP President John Herr. "Even more important to IACP members is Judge Corrigan's outright dismissal of the FDA's arguments that compounds prepared for an individual patient on the order of that patient's prescriber are 'new drugs' and should be subject to FDA's oversight."
"For more than six years, IACP has worked with our supporters and allies in Congress to have the FDA address its ill-founded 2003 Compliance Policy Guideline on veterinary compounding," explained David Miller, IACP Executive Vice President & CEO. "Multiple Congressional inquiries, letters, phone calls... all of them ignored by a regulatory agency so sure of its 'rightness' in claiming that compounders were violating laws. Well, today, they were proven wrong by the courts. The tireless efforts of our members and our staff, the courage of Paul Franck to fight the FDA itself, and the commitment of IACP to its mission of the art and science of compounding has paid off."
Judge Corrigan's ruling cites a number of landmark court cases and decisions affecting IACP members in addition to addressing the specific issue of APIs in veterinary compounding. The document numbers more than 80 pages and provides an exceptional summary of the case as well as the FDA's attempts to grant itself authority that Congress never intended it to have. IACP will be providing additional information about the specific points in the ruling as part of our regular communications to members. To read the entire decision, click here.
In an effort to provide our members with the latest information relating to the compounding profession, the International Academy of Compounding Pharmacists (IACP) has provided PCCA with this latest news. If you are not already a member of the only non-profit pharmacy organization dedicated to protecting, promoting and advancing the art and science of pharmacy compounding, please contact IACP (281-933-8400 / www.iacprx.org) to join today.
© 2011 International Academy of Compounding Pharmacists. All Rights Reserved.
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