Should the FDA have the authority to stop pharmacies from using bulk ingredients to compound prescription meds for non-food producing animals, such as dogs and horses? In an interesting case, a federal court judge has ruled the agency does not have this authority but, moreover, attempted to overstep its bounds in a potentially draconian way that might have harmed pharmacies and animals.
The issue involves the basic premise that state-regulated compounding pharmacies should have the right to mix bulk ingredients in order to fill a prescription from a veterinarian. The FDA, however, worried such activity may offer the potential to blur the line between valid compounding and mass manufacturing of a new drug - and sought to exercise long-dormant authority over the practice.
The case marked the first time the FDA attempted to prevent a legitimately licensed pharmacist from bulk compounding of animal meds. In arguing its position, the agency maintained Congress offered such latitude under the Food, Drug & Cosmetic Act. But not only was the FDA ruled incorrect, the agency undermined its own cause by failing to allow for public comment on guidances that addressed the issue, and then failing to publish a promised follow-up guidance.
"The court holds that, in enacting the FDCA in 1938, Congress did not intend to give the FDA authority to enjoin the long-standing, widespread, state-regulated practice of pharmacists filling a veterinarian’s prescription for a non food-producing animal by compounding from bulk substances," US District Judge Timothy Corrigan wrote.
He also noted that, "is not at all clear that Congress meant to hide the elephant of the FDA’s regulation of traditional pharmacy compounding in the mousehole of the FDCA’s new drug approval process...even if Congress had implicitly delegated authority to the FDA to regulate traditional pharmacy compounding of animal medications, the FDA has never promulgated regulations to this effect through notice-and-comment rule-making."
The focus of the case is squarely on bulk compounding animal meds, but can be instructive for both the FDA and those who closely track how the agency interprets and enforces regulations, as well as attempts to communicate its positions on various issues. For these reasons, it may be worth investing the time to peruse the 80-page ruling (which is right here).
For those who cannot indulge, here is the brief background: the FDA focused on a Florida pharmacy called Franck's Lab, which compounds meds for humans as well, after issuing a warning letter in 2005 in which the agency expressed concern that drugs were being manufactured using bulk ingredients. Franck's disagreed and noted such activity is regulated by the state.
The FDA did not respond or take any action, but a mishap in 2009 renewed agency attention. A veterinarian commissioned Franck’s to compound an injectable solution of a prescription drug for the Venezuelan national polo team and, due to a mathematical error in converting an ingredient, which went unnoticed by the prescribing veterinarian, the med was too potent and 21 polo horses died.
The incident was investigated by the Florida Board of Pharmacy, which imposed fines and reprimanded Franck’s for the misfilled prescription. The FDA subsequently reinspected the facilities and issued a 483 inspection letter. As Corrigan noted, none of the five specific problems cited mentioned bulk compounding of animal drugs as a concern, but in 2010, the FDA went to court to stop Franck's from compounding animal meds.
Although Corrigan acknowledged the need for the FDA to be able to enforce against manufacturers "masquerading" as compounders, he also noted that even large operations such as Franck's are ill-equipped to conduct the sort of testing that is needed to verify the veracity of a new animal drug made from bulk ingredients.
"If the FDA’s position is correct, Congress intended to give the agency the authority to require traditionally compounded medications for non food-producing animals to go through the FDA’s lengthy and involved new drug approval process but declined to require it for compounded medications prescribed for human beings. This is simply too much for a public health statute like the FDCA to bear..," he writes.
"What the FDA seeks to do here is reinterpret the FDCA to allow it to eradicate the line between manufacturing and traditional compounding of animal medications. Its wholesale assertion of authority over traditional pharmacy compounding in the context of a pharmacist-veterinarian-patient relationship is contrary to congressional intent."