The outbreak of fungal meningitis linked to contaminated steroids produced by New England Compounding Center (NECC) has led to calls for new legislation to provide greater federal oversight of compounding pharmacies. In particular, there is concern that many compounding pharmacies, including NECC, have been producing large quantities of medication for bulk distribution, in the manner of small drug manufacturers. Drug manufacturers are overseen by the FDA, while compounding pharmacies are generally overseen by state boards of pharmacy.
On October 12, 2012, US Representative Edward Markey (D, MA), whose district includes Framingham, Massachusetts, where NECC is located, issued a statement noting that compounding pharmacies are “governed by patchwork regulations, with federal and state agencies engaging in piecemeal oversight” and calling on Congress to act to ensure patient safety. In the statement, Rep Markey vowed to introduce legislation governing compounding pharmacies that would clarify the distinction between compounding pharmacies and drug manufacturers, require compounding pharmacies to report adverse events to the FDA, and require that patients be warned that compounded medications have not been approved by the FDA.
On October 16, 2012, Markey issued another statement noting that many of NECC’s formulations contained controlled substances and asking the US Drug Enforcement Administration to determine whether it requires increased authority or resources to effectively oversee the use of controlled substances by compounding pharmacies.