Lawmakers Consider New Oversight of Compounding Pharmacies After Meningitis Outbreak of 2012

After tainted steroid injections caused a deadly fungal meningitis outbreak, the FDA is pushing for increased oversight of compounding pharmacies.  The New England Compounding Center (NECC), now bankrupt, was identified as the site where infected steroids were compounded.  The investigation following the tragedy revealed that unsanitary conditions and poor record-keeping were directly linked to the meningitis outbreak. NECC was also found to be making and shipping drugs that had not been specifically ordered.

According to research included in a story written by Tim McLaughlin in late 2012 for Reuters, the NECC had repeatedly “escaped harsh punishment from health regulators several times in the years leading up to the health crisis that has raised questions about oversight of the customized drug mixing industry.” McLaughlin advised that troubles at NECC began soon after the company opened its doors in 1999, and no action was taken despite mounting complaints.

In the past, compounding pharmacies were generally small operations that created specialized prescriptions based upon doctors’ orders within their own state.   As such, state pharmacy boards have thus far been responsible for oversight of compounding facilities.  Within the last decade, however, compounding has become more sophisticated and these operations tend to create highly-customized drugs and treatments.  As an example, some prepare specialized veterinary medicines, or treatments for women experiencing menopause.  Compounding pharmacies are also now preparing large orders that are not always specifically requested for particular patients.  Many materials are being shipped across state lines and imported from other countries.  These, and other complexities, have made state regulation of these pharmacies increasingly difficult.

As a result of the NECC incident, Congress is reviewing whether the FDA ought to become responsible for oversight and enforcement of the compounding industry.  At a Senate hearing on May 9th 2013, the head of the National Association of Boards of Pharmacy, Dr. Carmen Catizone, testified that compounders are really more similar to drug manufacturers than they are to pharmacies.  Dr. Catizone opined that compounding pharmacies need to be regulated by the federal government like any other drug manufacturer.  He advised that the current state of regulation allows compounding facilities to, in effect, be within a “grey zone” between state and federal regulations. This grey zone, he testified, may have contributed to the problems that lead to the meningitis outbreak of 2012.

At the same Senate hearing, Pew Charitable Trusts disclosed a report which revealed that besides the NECC meningitis outbreak, “there have been 75 reported deaths and more than 1,020 illnesses connected with compounded drugs.”  Compounding facilities throughout the nation have come under increased scrutiny by state and federal investigators.  Congress has yet to pass any legislation, but there is certainly much momentum in that direction.  One thing is clear—Congress must start with establishing clear and bright lines between the legitimate practice of pharmacy, and those firms operating illegally as large-scale drug manufacturers under the guise of a pharmacy license.  Such a classification process will aid in the determination of which pharmacies fall within the jurisdiction of the state boards board of pharmacy, and those which ought to be federally regulated.