DeLauro, Lowey Introduce Legislation Strengthening Oversight of Compounding Pharmacies

December 5, 2012
Press Release

Bill Would End Current State-by-State, PatchworkSystem

WASHINGTON,DC—Representatives Rosa DeLauro (D-CT) and Nita Lowey (D-NY) introducedlegislation today to improve the failed regulatory framework currentlygoverning compounding pharmacies and clarify the Food and Drug Administration(FDA)'s ability to oversee such pharmacies. A compounding pharmacy inMassachusetts was responsible for the meningitis outbreak that sickened over500 people and caused at least 36 deaths.

"Iwish this legislation were not necessary, but recent, tragic events have proventhat it is," DeLauro said. "The actions of the New EnglandCompounding Center have made clear that strong Federal authority is necessaryto ensure patients know they are receiving safe compounded drugs. It hasalso become clear that federal and state regulators must better communicate toidentify trouble facilities and leverage their resources to protectpatients.

"Yesterday'sannouncement that multiple NECC products were contaminated simply underscorethat this was not an isolated incident. We must end the current regulatorymorass so that no more lives are placed at risk."

Loweysaid:"As recent events have made clear, it is critical to ensure compoundingpharmacies are operating safely and the products consumers receive will improve- not jeopardize - their health. Federal oversight is critical toidentify and correct potential problems and keep consumers safe."

TheSupporting Access to Formulated and Effective (S.A.F.E.) Compounded Drugs Actwould:

  • Require compounding pharmacies to register their facility with the FDA
  • Ensure patients know they are receiving a compounded drug
  • Require compounded drugs to be labeled appropriately
  • Establish a FDA database of information on compounding pharmacies to inform oversight by the FDA and appropriate state regulators
  • Ask the FDA to set minimum production standards
  • Direct the FDA to offer training opportunities for state regulators
  • Seek additional information on third party accreditation and the various models used by state regulators
  • Improve communication between federal and state regulators to facilitate more comprehensive inspections

DeLauro,a senior member of the committee responsible for funding the FDA, announced shewould introduce the legislation on October 9, the same day she wrote to Healthand Human Services Secretary Sebelius on the issue. On October 19 she andRepresentative Sanford Bishop wrote to Sebelius and Veterans Affairs SecretaryShinseki to ensure the safety of pharmaceuticals given to participants inMedicare, Medicaid, and the Veterans Health Administration.