Legal Updates

Big Win for the Midland coalition and Compounding Pharmacies!!!


Wednesday, August 30, 2006
Midland, Texas 

Congratulations! Today, Federal District Judge Robert Junell issued his written ruling in our favor in our case against the FDA, styled Medical Center Pharmacy, et al. v. Gonzales, et al.

Ad Deum Gloriam – To God be the glory! We thank God for this victory. We owe a debt of gratitude to Terry Scarborough and Matt Slimp for their outstanding legal representation in this case.

In summary, these are the written findings of Judge Junell:

1. Compounds prepared by compliant pharmacies, like the Plaintiffs, are not "new drugs" or "new animal drugs."

2. The FDA cannot conduct third-sentence inspections of the Plaintiffs' pharmacies and is prohibited from punishing them if Plaintiffs' refuse, so long as Plaintiffs remain compliant.

3.  Compliant pharmacies, like Plaintiffs, may compound from legal bulk drug ingredients for non-food animals.

4. The Court will not strike down the Veterinary CPG and Notice in their entirety, but the FDA is no longer allowed to enforce the portions that conflict with the Court's opinion.

5.  Prospective injunctive relief is denied WITHOUT PREJUDICE, meaning, if the FDA takes any action that violates the decision, then the Plaintiffs can seek injunctive relief at that time.

This is the most important legal decision in the history of compounding pharmacy.  The FDA has claimed for at least the past 15 years that all compounded preparations were illegal new drugs. Furthermore, the FDA has used discretionary enforcement of this claim and harassed legitimate compounding pharmacies across the nation. Judge Junell’s ruling shatters the FDA’s claim and declares that compounded preparations are legal. This decision benefits every compounding pharmacy in the United States.

My thanks goes out to our relentless attorneys and all who supported this cause.