Fungal Meningitis and the End of Lackadaisical FDA Involvement in Compound Pharmacies

New England Compounding Center (NECC) is at the center of this quite horrific tragedy that has affected the lives of many with fourteen already dead. I cannot personally fathom such a loss over something so seemingly accidental. As a pharmacist my thoughts immediately go to sterile technique and the FDA's regulation of our industry. You see, the states oversee the pharmacies compounding and normally that should be enough. However, something went terribly wrong here. But what is coming out lately is the role of compounding pharmacies and how in this case, there was a grey area they were working in. Basically compound pharmacies can make patient specific medications, what is not allowed is these compounding pharmacies acting as manufacturing and bulk shipping repackaged medications without FDA oversight.

It's all about the dollar, but in this case many priceless lives have been lost.

There are two fungi involved: aspergillus and Exserohilum rostratum.

In the past, these pharmacies have been the heroes making things like bioidentical hormones and other specialty concoctions.

Under the FDA's definition, compounding pharmacies are supposed to mix drugs to order only on a specific patient in response to a prescription from a doctor. Under this definition NECC was not operating as a compounding pharmacy but as a large-scale production of a drug. The FDa should have stepped in before these lives were lost.

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