Congress Clears Compounding Oversight Bill
Nov. 18—The Food and Drug Administration (FDA) would gain increased regulatory powers over some compounding pharmacies under legislation passed by the Senate Monday.
The bill, known as the Drug Quality and Security Act, would authorize FDA oversight of large-volume drug compounding firms that opt to register as outsourcing facilities. Compounders that chose to remain traditional pharmacies would stay under state-level regulators.
Rep. Fred Upton (R-Mich.), chairman of the Energy and Commerce Committee, introduced the bill after a 20-state fungal meningitis outbreak in the fall of 2012 was traced to unsanitary conditions at a Massachusetts compounding firm. The outbreak was linked to 751 cases and 64 deaths, according to the Centers for Disease Control and Prevention.
The bill, which was passed by the House of Representatives in September, would require facilities subject to FDA oversight to regularly report what drugs they compound, submit adverse event reports and allow inspections.
Other provisions of the legislation would expand prescription drug tracing through the pharmaceutical supply distribution chain, including the use of product identifiers on every drug package they distribute.
The nonpartisan Government Accounting Office concluded in July 2013 that proper oversight of compounding pharmacies required congressional action to clarify which agencies had that authority.
The bill’s passage drew praise from hospital advocates.
“This much-needed legislation will help ensure that consumers have peace of mind about the safety and quality of compounded prescription drugs,” Chip Kahn, president and CEO of the Federation of American Hospitals, said in a written statement. “It also is important that the measure assures the ability of hospitals to provide patients with the safe, reliable, and effective pharmaceutical products required for their care.”
Publication Date: Monday, November 18, 2013