Both facilities, which ceased production last April amid contamination and safety concerns, are in the NIH Clinical Center. NIH said it has closed the facility known as the Pharmaceutical Development Section, which produced investigational drugs for clinical studies located at NIH, according to the report. The other pharmacy changes existing drugs into a form appropriate for a given patient or study.
As far as the PDS pharmacy, NIH said a “vast majority” of its studies have been able to continue using products “from alternative sources,” such as drug-outsourcing companies, The Wall Street Journal reported.
NIH had hired two companies to evaluate all of its facilities that produce sterile or infused products after major issues were found last year by the FDA at the NIH Clinical Center Pharmaceutical Development Section.
FDA inspectors said the other pharmacy, called the Intravenous Admixture Unit, worked with drugs intended to be sterile but “may have become contaminated,” according to the report.
The NIH said it recently told the FDA that the NIH had taken “significant steps” to resolve conditions found in its inspection, the report states.
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