NIH Closes In-House Pharmacy Faulted for Sterility Processes

http://www.wsj.com/articles/nih-closes-in-house-pharmacy-faulted-for-sterility-processes-1470431144

Bethesda, Md.—The National Institutes of Health said it is permanently closing one of two pharmacies that were the subjects of critical reports over their sterility processes a year ago after inspections by the Food and Drug Administration.

Both drug-production facilities are located in the NIH Clinical Center, the NIH’s renowned hospital that largely treats patients who are entered in clinical studies there.

The federal medical-research agency on Friday said it has closed the facility known as the Pharmaceutical Development Section, or PDS, which manufactured investigational drugs that were used in clinical studies located at NIH. The other pharmacy does drug compounding, meaning it takes existing drugs and changes them into a form appropriate for a given patient or study.

Regarding the PDS pharmacy, the NIH said it has been able to keep the “vast majority” of its studies underway by getting products “from alternative sources,” such as drug-outsourcing companies.

An FDA inspection in May 2015 found what the agency termed “significant violations of current good manufacturing practice” at the PDS, such as failing to thoroughly investigate discrepancies in drug batches.

FDA inspectors said the other pharmacy, called the Intravenous Admixture Unit, worked with drugs intended to be sterile but “may have become contaminated.” The NIH said it has been working to correct the problems, and in a recent letter the FDA noted the NIH had taken “significant steps” to resolve conditions found in its inspection.

Filed under: General Problems