September 26, 2013

Legislation Agreed Upon to Address High-Risk Drug Compounding Practices

Posted in: Latest News

WASHINGTON, DC – Leaders from the Senate and House committees overseeing health policy today announced that they have reached an agreement on legislation to help ensure the safety of compounded drugs and our nation’s pharmaceutical supply chain. This legislation, the Drug Quality and Security Act, reflects a bipartisan, bicameral effort to improve drug safety and help prevent a future public health crisis like the 2012 meningitis outbreak tied to the New England Compounding Center.

The bill clarifies current federal law regarding pharmacy compounding and resolves the patchwork of current federal regulation by applying a uniform standard nationwide.

Further, compounders who wish can register as outsourcing facilities, but those who choose to remain traditional pharmacies will continue to be regulated primarily by state boards of pharmacy, as they are in current law. Outsourcing facilities would be subject to oversight by the U.S. Food and Drug Administration (FDA) in much the same way as traditional manufacturers are monitored. FDA will know who these outsourcers are and what they are making, receive adverse event reports about compounded drugs, and have the authority and resources to conduct risk-based inspections.

The second title of the bill would replace today’s patchwork of state prescription-drug tracing laws by creating a new uniform framework for tracking drugs from the manufacturer to the pharmacy. There is currently no system for tracking the drugs that make up some four billion prescriptions per year in the United States, which means drugs that are stolen or counterfeit may not be discovered before reaching consumers.

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