Judge Junell's initial ruling, in our case in Midland this past Thursday, gives us much about which to be encouraged, but it was only a partial decision.
Judge Junell indicated to the the plaintiffs that his complete ruling would probably be issued later this summer. Nothing would be binding until after he had written and signed his decision.
This ruling means that compounded preparations are legal and therefore not subject to the requirements and prohibitions imposed upon such drugs under the Food Drug and Cosmetic Act of 1938. Judge Junell appeared willing to provide injunctive relief against illegal inspections being made of state compliant compounding pharmacies by the FDA. He requested that our attorney's draft language on injunctive relief. It is important that the relief which we recommend to the Judge can hold up under the government's challenge in the 5th Circuit.
Judge Junnel apparently needs additional time to decide on the non food animal compounding issue. He did ask for short briefs from the attorneys regarding this issue..
Our attorneys feel optimistic about the Judge Junell's final decisions regarding compounded preparations for non food animals based upon his initial ruling on compounded preparations for humans. We will not know until later this summer.