Air filters marked with dark-amber stains, unexplained variations in drug purity, patients' complaints dismissed without investigation: All were among the deficiencies cited at 31 drug-compounding factories inspected in the past seven weeks by the Food and Drug Administration.
In the wake of last year's deadly outbreak of drug-borne fungal meningitis, the FDA has undertaken an aggressive inspection program at higher-risk facilities around the country that produce the sterile compounded drugs on which many hospitals rely.
As of Thursday all of the reports were available online, documenting conditions so severe that in some cases the firms voluntarily recalled products or temporarily suspended production while they corrected deficiencies found by investigators. The firms were selected for “proactive” inspection based on past adverse event reports, historical inspection data and reports of quality problems.
On Tuesday, the House Oversight and Investigations Subcommittee is scheduled to hold its second hearing examining the meningitis outbreak, specifically probing the question of whether the outbreak caused by injected compounded drugs could have been prevented.
Hospitals and outside companies routinely transform solid drugs into injectable form, or “compound” them, as a way to preserve their shelf-life and stretch supplies amid drug shortages. But compounding requires sterile conditions to avoid tainting the remixed drugs. At least 53 people died last fall after contaminated drugs mixed by the New England Compounding Center were given to patients in 20 states.
Usually, the hospitals that use compounded sterile drugs buy them from vendors such as the 31 the FDA has inspected since February, rather than doing the compounding in the hospital pharmacy.