U.S. District Court Judge Robert Junell ruled on August 30 that “it is in the best interest of public health” to uphold the legality of compounded drugs. In the past, FDA had proposed that, even though it is impossible to do so, compounded medicines must meet the same new drug requirements to which mass produced, one-size-fits-all, manufactured products are subjected and that compounded medicines are illegal unless they do so. Ten pharmacies took the FDA to court in 2004 on the grounds that this theory was incorrect. The Court sided with the pharmacies.
Judge Junell explained: “If compounded drugs were required to undergo the new drug approval process, the result would be that patients needing individually tailored prescriptions would not be able to receive the necessary medication due to the cost and time associated with obtaining approval. … It is not feasible, either economically or time-wise, for the needed medications to be subjected to the FDA approval process. It is in the best interest of public health to recognize an exemption for compounded drugs that are created based on a prescription written for an individual patient by a licensed practitioner.”
In a victory for pet owners, zoo keepers and other animal lovers, the Court also ruled that compounding for non-food animals from bulk pharmaceutical ingredients is legal. Despite the fact that many animals suffer from conditions that require treatment using compounded medicines prepared from pure pharmaceutical ingredients, FDA proposed that use of such ingredients was illegal.