Wednesday, March 20, 2013

How the FDA Decided Which 30 Compounding Pharmacies Where "High Risk" And Should Be Inspected


In response to the scandal over a fungal meningitis outbreak, the FDA has begun a crackdown on compounding pharmacies and targeting about 30 ‘high risk’ operations in nearly a dozen states and made a point of posting inspections reports were issued for several compounders for a variety of serious manufacturing violations.
Rather than wait for complaints to be filed against compounders, the agency is using a “risk-based model that relies on adverse event reports, historical inspection data, reports of quality problems and public information to identify pharmacies that may pose higher risks and are known to have engaged in sterile compounding.
The FDA has suffered harsh criticism for failing to pursue enforcement action against the New England Compounding Center, which has been linked to 722 cases of fungal meningitis, including 50 deaths. The outbreak, which has been described as one of the worst such public health crises in the US in decades, has prompted lobbying by drug makers to curb compounders and Congressional probes into FDA decision making.
The House Energy and Commerce Committee is leaning on the FDA to disclose documentation concerning its actions toward the NECC. In response, the FDA has begun coordinating its efforts with state board of pharmacy in identifying compounders and making its findings available to all states on its website, since many of the riskier compounding pharmacies ship across state lines.

Quoted from Pharmalot found here

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