On Monday, a district court in Florida issued a ruling that denied FDA’s request for an injunction to prohibit Franck’s Lab from compounding veterinary drugs from bulk active ingredients. There were some key points in the court’s ruling:
- In reviewing the legislative history of the Federal Food, Drug, and Cosmetic Act, the court believed that Congress did not intend for FDA to subject pharmacy compounded drugs to the FDA’s new animal drug approval process.
- The court suggested that Congress did intend to give FDA the ability to draw the line between traditional “compounding” and “manufacturing” masquerading as compounding.
This is the most recent of a set of court cases with mixed rulings. What does this particular ruling mean for veterinarians? The real outcome of the ruling is that Franck’s Lab is still able to conduct its business. What will happen next with federal rules and the FDA’s Compliance Policy Guide on Compounding of Drugs for Use in Animals (CPG) is unknown…perhaps there will be an appeal to the current case, or perhaps FDA will consider revising its CPG and/or developing rules on compounding for public comment (the court essentially encouraged the FDA to draw the line between traditional compounding and manufacturing under the guise of compounding).
What we do know is that the FDA’s Extralabel Drug Use Rules and its CPG are still in place, and the AVMA’s standing policies (Compounding; Compounding from Unapproved (Bulk) Substances) still state the importance of following FDA’s rules and its CPG. AVMA’s Compounding policy also says compounding should be limited to:
- those drugs for which both safety and efficacy have been demonstrated in the compounded form in the target species;
- disease conditions for which response to therapy or drug concentration can be monitored; or
- those individual patients for which no other method or route of drug delivery is practical.
We also have a recently revised compounding brochure which explains the FDA’s rules on compounding.
Two of our volunteer governance groups – the Council on Biologic and Therapeutic Agents and its Clinical Practitioners Advisory Committee – will be receiving information about the recent court case and looking at whether there are additional educational or advocacy activities for AVMA to pursue regarding compounding. In the end, veterinarians should have the drugs they need for preventing and relieving animal pain and suffering, and they should also be well equipped with the knowledge they need to do compounding appropriately in their clinical practice.