Drug compounders get cleanliness guidance from FDAReprints
Federal regulators have released suggestions for drug compounding companies on how to maintain a clean work environment.
The U.S. Food and Drug Administration on Thursday released draft guidance to caution against “insanitary conditions” that could cause a drug to become contaminated with filth, causing serious adverse events in patients, including death.
Injectable drug products produced at a compounding facility and then distributed across the nation caused a fungal meningitis outbreak in 2012, causing 60 deaths and 750 cases of infection, the draft guidance said.
The draft guidance is to help compounding facilities in identifying insanitary conditions so that they can correct them and also to assist state regulatory agencies in understanding some examples of what FDA considers to be insanitary conditions, the FDA said in a statement.
A few examples given in the draft guidance of insanitary conditions included seeing rodents in the production areas or finding hairs or mold in the production area.
Public comment of the FDA's draft guidance should be submitted by Oct. 3, 2016. Instructions for submitting comments are available here.