A word to the wise

Published December 4, 2020

The FDA isn’t going for subtlety points with an article it posted — an interview with CDER division director Ian Deveau in which he’s clear that compounders are very much on the agency’s radar. “[T]he NECC tragedy was not unique,” he says, and “we continue to see harm to patients because of poor compounding procedures.”

Insanitary conditions — “filth, dirt, mold, peeling paint, chipped drywall, damaged air filters and so on” — are one focus for inspectors, who are looking with a careful, pharmaceutical eye. Keep that in mind, and do it yourself before an inspector does.

As Deveau points out, “So many of our findings are the kinds of things most people would look at and not recognize as dangerous. But when you are assessing them in terms of preparing drugs that will be injected into peoples’ bodies, they really matter. “