A landmark victory for compounding pharmacies, veterinary professionals, livestock, pets and their owners.
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. The Food & Drug Administration brought on the lawsuit against IACP-member, Paul Franck and his pharmacy, alleging that the use of active pharmaceutical ingredients (APIs) in compounded 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 the preparations are considered “new drugs” and are therefore subject to FDA review and approval.
Judge Corrigan’s ruling was in favor of Franck’s Lab, Inc., and therefore a victorious ruling for compounding pharmacists, veterinary professionals and the animals they treat through compounded medications.
IACP President John Herr stated that “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.”
“Even more importantly,” Herr continues, ““ … 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.”
This ruling refutes the FDA’s attempts to exert unauthorized jurisdiction over compounding, it is sharply critical of the FDA’s approach towards veterinary compounding in general.
