Mold found in NIH pharmacy

Safety issues have again popped up in pharmaceuticals at the National Institutes of Health (NIH), with the problem this time being “environmental mold” found in a sucrose solution.

As first reported by the Washington Post, a NIH nurse discovered the contamination in the sugar-and-water mouth rinse Dec. 12, which was placed into quarantine before it was given to any patient. Nine bottles were eventually discovered to be tainted by particles cultured at NIH Clinical Center's Microbiology Section. Three of the bottles contained mold.

The clinical center had been the center of safety issues in 2015, when a FDA inspection forced the closure of a sterile production unit within the center’s Pharmaceutical Development Section. A 2016 report found while no patients had been harmed, there was a culture within NIH of placing research needs above patient safety.

NIH Director Francis Collins, MD, PhD, later acted on the safety concerns by shaking up the management team at the clinical center. Its first CEO, Major General James K. Gilman, MD, U.S. Army (retired), was selected for the role around the very time the sucrose contamination was discovered.