Four years ago this month, a cloud of controversy enveloped the compounding pharmacy industry after a multi-state outbreak of fungal meningitis was traced to the New England Compounding Center in Massachusetts.
As the tragedy's toll became clear, questions and accusations swirled. Who is to blame? What went wrong? How many compounders operate like NECC? Who is minding the store - the state pharmacy board or the FDA? Will new regulations prevent the "next NECC"?
Today, while the victims await justice in the form of criminal prosecution and compensation resulting from civil litigation, the compounding pharmacy profession operates under much more stringent oversight by individual states and the federal government. New laws (see the DQSA) have been passed, new regulations implemented. Pharmacists and pharmacy owners are expected to do more than ever to ensure quality and maintain compliance.
And yet the cloud from NECC remains. Regulators continue to crack down on compounders, often imposing manufacturing-class requirements on mom-and-pop pharmacies. Some patients and providers look askance at compounders, ignoring their proven benefit to truly personalized health care. And the legal landscape continues to evolve: There is word that the FDA soon may approach Congress to secure even greater regulatory authority over compounders.
Just what is around the corner is unclear, but investing the necessary time and resources in policies, procedures, training, equipment and staff to ensure quality and compliance will go a long way toward ensuring success and survival in the post-NECC environment.
