New England Compounding Center

Compounding pharmacies must use FDA approved ingredients by law, but the actual formulations themselves aren't evaluated for purity, safety, or effectiveness.

Compounding pharmacies also are not routinely FDA regulated, which has led to sanitation and contamination issues in the past, such as a 2012 case in which nearly 800 people became ill and 64 died of a fungal meningitis outbreak caused by unsanitary conditions from the New England Compounding Center.

Or 2023 FDA reports of compounders using unapproved salt forms of ingredients in their formulations.

Several lawsuits and legal challenges have marked the battle between compounders and the name brand drugs patent holders.

You know, it, it's been around for I guess a pretty long time now.

I mean, the New England Compounding Center stuff that, that prompted it was, was that probably 10, was it 15 years ago now? Probably not that long.

But, um, you know, it, it, it's, it ...

I think, I don't know how, you know, how well FDA is able to get out to a lot of these compounders and kinda keep them all, you know, within making sure that, make, you know, make sure they're all, you know, within GMPs and, and everything, and the rules that are, they're supposed to be following in addition to, you know, all the drug manufacturing and all the device manufacturing and all the other things that the inspection, um, cadre has to, you know, has to deal with.