The FDA says it has begun a new crackdown on compounding pharmacies that is targeting about 30 so-called ‘high risk’ operations in nearly a dozen states. Late last week, it disclosed that inspections reports were issued for four compounders for a variety of serious manufacturing violations.
The agency used a “risk-based model that relied on adverse event reports, historical inspection data, reports of quality problems and public information, to identify a number of pharmacies that may pose higher risks and that are known to have engaged in sterile compounding. These include many with which the FDA has had issues in the past.”
The agency has been criticized for moving too slow in the past and has at least one house committee looking over its shoulder. In response to this mounting pressure, the FDA has begun coordinating its efforts with state boards of pharmacy in identifying compounders and making its findings available to all states on its website, since many of the riskier compounders ship across state lines.
As The Thing might say, "It's clobbering time." Of course, FDA might have to ask permission to do so and be relegated to refering cases to state boards for actual action. Not ideal.
Posted by Bruce Lehr Mar 4th 2013.