Wednesday, May 15, 2013
Senate pushes bill to regulate compound pharmacies AP News | May 15, 2013
WASHINGTON (AP) — Senate lawmakers are pushing ahead with a bill that would bring new federal oversight to large specialty pharmacieslike the one that triggered a deadly meningitis outbreak last year.
The bill introduced Tuesday by Democrats and Republicans would subject such large compounding operations to direct federal oversight by the Food and Drug Administration, rather than the state pharmacy boards that have traditionally overseen them.
The effort responds to last year's outbreak tied to contaminated compounded drugs that sickened more than 740 Americans and killed 55 others. The wave of
fungal infectionswas identified in September and linked to a large Massachusetts compounding pharmacy, which regulators said was operating more like a manufacturer.
The legislation targets pharmacies that compound sterile drugs without a doctor's prescription and ship them across state lines.