Harsh punishments rare for drug compounding mistakes

from the article:

Through them all, there’s a pattern: When a compounding pharmacy commits serious transgressions — wrongs that endanger lives or involve large-scale criminal conspiracies — the regulatory sanctions often are minimal. Tougher punishments frequently come in the form of personal injury lawsuits, which can elicit court-ordered penalties far more potent than, say, the suspension of a pharmacy’s license.

—–

Criminal penalties are possible — criminal investigators from the U.S. Justice Department and the FDA are involved in the NECC probe. But such prosecutions are extremely rare, in part because the law makes it very difficult to hold pharmacists criminally liable for problems with the drugs they produce or dispense.

I wonder what Eric Cropp thinks about this statement?

Sarah Sellers, a former FDA compliance official, who now runs Q-Vigilance, a drug-safety consulting firm, says she doesn’t ever recall seeing another case in which a state shut down a compounding pharmacy permanently. She believes that might be due partly to the fact that state pharmacy boards often have members who operate or have interests in compounding pharmacies. “If there is conflict of interest at the state level, that may be a contributing factor in the lack of enforcement,

Does this suggest that because 75% of the BOP’s have chain exec sitting on them… there are few consequences to chains when things go wrong ?

The article is long and the list of bodies and harmed patients from compounding pharmacy dot the country.

Filed under: General Problems