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.
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A pharmacist gets a degree to become a compounding pharmacist and they know alot more about how medicines affect our body than our current day doctors do. Compounding is a right for them and for the people that they serve. It is also our right to have a medicine compounded for us. The big pharma companies are trying to manipulate to their advantage and many people know we have to resist this erosion of our freedoms on this front particularly.
It is true! we need to uphold any and all of our rights. This to me is one of the most important ones our freedom of speech. seems funny to me that we have to fight for this, but we do and we all need to be well informed that Mr. government is constantly steping on our toes in this area. So, joe government BACK OFF. were not going to ever let you get away with infrenging on our writes.
I agree you have no right to keep pharmicists from doing what they spent lots of money learning to do leave them alone to do what is best for human health since they clearly have that as their true interest, whereas big Pharma seems to be only interested in the bottom line($$$)