NECC News: Another Person Dead, More Fungal Meningitis Lawsuits Filed, and Fungus Found in 50 Vials
Per the article:
“the FDA has known that NECC was mass-producing drugs since at least December 2006”
It was also during this same year that a division – based in the mid-west – of a large public HME company was compounding identical or nearly identical albuterol inhalation solutions. … a readily commercially available product… and it was reported at that time… that the FDA has investigated this “compounding pharmacy” and took samples and found sub-potent, super-potent and contaminated product. The FDA sent them a “pretty please” letter to stop producing. I personally talked to the BOP inspector who had been inspecting this operation for years and the inspector did not see anything that they were doing wrong.
After the initial media attention.. information faded away… how many asthmatic or COPA pts received inappropriate therapy or given a upper respiratory infection from the contaminated products… who knows…
The FDA knew… should we think that the FDA did not share this information with the MA BOP? Where those in the FDA was not aware that this was a violation of FEDERAL LAW.. or the state’s practice act?
Is the system that oversee pharmacy & medication completely shattered?
Filed under: General Problems
Regulatory agencies responsible for safe guarding public safety with regard to pharmacy services have lost all control and can only REACT to matters of public safety after the damage has been done.
As I wrote in a recent post http://www.thecandidpharmacist.com/2012/10/pharmacy-regulatory-agencies-no-longer.html
– Corporations will continue to abuse the laws and regulations governing pharmacy until they are held accountable by the BOPs, FDA and DEA when they create unsafe working conditions (including inadequate quality control) that lead to endangerment of the public.
– Until then patients beware and pharmacists run for cover!