Contamination at NIH’s clinical pharmacy center halts operations

WASHINGTON — The National Institutes of Health has halted all production at its clinical pharmacy center after the discovery of two vials contaminated with fungus.

 

Six patients are being monitored for any sign of infection after being administered vials from the same batch found in the two vials. It’s not known if those vials were contaminated.

 

“To date these patients show no sign of any difficulty,” says Dr. Larry Tabak, Deputy Director, NIH. “All of the patients that have received products produced in this facility have been contacted.” 

 

A Food and Drug Administration inspection detected the contamination in mid-May, and the pharmacy’s operations were suspended on Thursday.

 

Outside investigators, including microbiologists and experts in sterile manufacturing, will conduct a review of operations at the clinical center pharmacy, after the FDA cited the facility for not following standard operating procedures for maintaining a sterile environment.

 

It’s unclear how long the shutdown could last.

 

“This is a case where being thorough is more important than being quick,” Tabak says.

 

 The NIH’s clinical pharmacy center produces drugs used in an estimated 46 NIH clinical trials. Without the compounds, Tabak says some trials may have to be put on hold.

 

“We are in the process of attempting to find alternate sources of medications for the patients that are in our clinical studies,” Tabak says.  

 

The fungus was found in two vials of albumin, which is used for administering the anti-cancer drug, Interleukin. Tabak says one vial contained an airborne fungus not harmful to humans, but the second vial contained Aspergillus fungus, which is potentially harmful to humans.

 

“Safety of our patients is the absolutely number one priority for us,” Tabak says.

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