By: Ebey P. Soman
With clearly established roles for pharmacists, compounding is recognized and upheld as a core foundation of the pharmacy profession. It allows pharmacists to provide unique and tailored medication regimens for their patients. The U.S. Food and Drug Administration (FDA) thought otherwise when the agency sued Franck’s Lab, Inc., a Florida-based compounding pharmacy for veterinary medication. This reflected the age-long battle waged by the FDA to expand its regulatory powers, especially via court cases against multiple aspects of pharmacy.
The U.S. Constitution gives states all powers not specifically granted to the federal government, thus enabling State Boards of Pharmacy to establish laws and guidelines needed to regulate the pharmacy profession. This issue came to the forefront when a compounding error resulted in the deaths of 21 polo horses from the Venezuelan National Polo Team in 2009. The pharmacy had compounded a drug called Biodyl (cyanocobalamin), which is unapproved in the US but commonly used for equine exhaustion. The compounded medication was a mixture of vitamin B-12, selenium (a form of sodium selenite), and other minerals, but due to the infamous “decimal-point error,” there was a lethal dose of selenium in the medication. The Florida State Board of Pharmacy specifically addressed the issue by fining the pharmacy for the mathematical error, and determined that it was not a problem with the compounding procedures of the pharmacy. However, the FDA did not agree, and subsequently filed Form 483 to determine if the pharmacy was compliant with FDA regulations against manufacturing.
In response, the pharmacy stated that the FDA did not have jurisdiction over this medication error, but the FDA filed motion for injunction against the pharmacy. An injunction would have stopped all pharmacy operations, including compounding of prescriptions, until a court hearing of the case and a decision on the matter. The FDA alleged that the pharmacy was involved in illegal animal drug manufacturing, and in violation of the Federal Food, Drug, and Cosmetic Act of 1938 (FDCA) and the FDA veterinary compounding Compliance Policy Guidelines (CPG).
The FDA continued its actions against the pharmacy by stating that all of the drugs compounded by the pharmacy with bulk ingredients were “new animal drugs,” which enables the FDA to regulate these products under the Interstate Commerce Clause. In essence, this would legally place the practice of compounding in equivalence to the mass production used by drug manufacturers – and, thus, make this compounding by pharmacists illegal.
The case came before the Florida Federal Court as United States v. Franck’s Lab, Inc. The court heard the arguments in February of 2011, and on September 12, 2011, the judge issued an 80-page opinion delving mostly into the statutory construction of the FDCA, the relevant amendments, and the FDA’s own regulations promulgated to enforce the congressional intent of the Act. In the opinion, the judge illustrated the long battles waged since the 1990s by the FDA against compounding pharmacists and the history of compounding as a central tenant of pharmacy profession.
The court said that the FDA’s argument that compounded medications need to be treated as new drugs and need to go through the new drug application process was an ‘especially poor fit’ for regulation compounding pharmacies. Historically, the State Boards of Pharmacy regulated compounding. They acknowledged that compounding is an important and accepted part of the pharmacy profession that provides clear benefits to society. The court also noted flaws in the FDA’s reasoning behind the lawsuit. Despite no clear legislation from Congress addressing veterinary compounding, the FDA tried to derive its authority to regulate compounding practice by broadly interpreting Congressional objectives in the Federal Food, Drug, and Cosmetic Act of 1938 (FDCA) and its amendments. The court also questioned the ridiculous logic behind the FDA suit with this comparison: “A pharmacist who compounds medication from bulk for ingestion by a horse is akin to a manufacturer and subject to an FDA enforcement action, while the same pharmacist compounding medication from bulk for ingestion by the human rider of that horse is not.”
In modern times, we appreciate the opportunities to tailor patient-specific medications without unjust regulation. Although unclear if the FDA will appeal the court’s decision, all pharmacists (not just those that practice veterinary compounding) perceive a victory. Without a vigorous, pre-established defense of legal rights, practiced or otherwise implemented by pharmacists across this nation, our profession’s central tenants will continue to face legal actions. These actions will attempt to slowly curtain and regulate more aspects of our profession, but we must work together to protect our freedoms.
- Milenkovich N. FDA Loses vet compounding case. Drug Topics. 2011, Nov 11. Available online: http://drugtopics.modernmedicine.com/drugtopics/Modern+Medicine+Now/FDA-loses-vet-compounding-case/ArticleStandard/Article/detail/748874
- Vivian J. FDA tries to compound the compounding rules. US Pharm. 2011;36(11):68-71.