President Barack Obama signed into law new legislation that gives the Food and Drug Administration (FDA) more regulatory control over compounding pharmacies. The move comes 15 months after authorities linked a multistate fungal meningitis outbreak to contaminated steroid shots manufactured and distributed by a Massachusetts-based specialty pharmacy.
The new law does not give the FDA as much control over compounding pharmacies as the agency had hoped, but it does give FDA the authority to conduct on-site inspections of pharmacies that mass produce custom-mixed drugs for distribution across state lines.
The FDA oversees drug companies that produce pharmaceuticals and over-the-counter medicines. But pharmacies that dispense drugs, as well as compounding pharmacies that custom-mix pharmaceuticals based on a doctor’s prescription, are regulated by state pharmacy boards. Some of these specialty pharmacies have turned to mass producing drugs for medical facilities and distributing them nationwide, which has raised safety concerns.
Those concerns became a real problem in September 2012, when Center for Disease Control and Prevention (CDC) officials determined that as many as 18,000 steroid shots made by New England Compounding Center (NECC) and distributed to medical facilities in 23 states were contaminated with fungus. The shots were given to about 14,000 people to treat back, neck and joint pain. Several people developed serious infections, including fungal meningitis. The steroid injections were recalled, as were all compounded products from NECC, and soon after the company filed for Chapter 11 bankruptcy. The company now faces numerous lawsuits. To date, 751 people have been sickened and 64 have died.
The new bill allows compounding pharmacies to be “outsourcing facilities” but only if they register and agree to regular inspections and higher quality standards. The standards for registered pharmacies, however, will still be less stringent than those for traditional drug manufacturers.