Today, Congressman Frank Pallone, Jr. (NJ-06) praised the passage in the U. S. House of Representatives of a bill that would to help ensure the safety of compounded drugs and our nation's pharmaceutical supply chain. Pallone, the top Democrat on the House Energy and Commerce Health Subcommittee, was a coauthor of the bipartisan Drug Quality and Security Act, H.R. 3204. The bill came in part in response to last year's tragic meningitis outbreak in Massachusetts caused by contaminated compounded drugs mixed at the New England Compounding Center, which killed 64 people and sickened 750 more.
"Today we are taking a critical step forward in securing the safety of our drug supply chain by creating a product tracing system and improving the quality of compounded drugs, which unfortunately have operated in the past under a faulty law. This legislation will allow FDA to require higher standards for certain drugs and better protect the public health," said Pallone.
Compounding pharmacies mix drugs tailored to specific patient needs. This legislation clarifies current federal law regarding traditional pharmacy compounding applies a uniform standard nationwide. Compounders will have the opportunity to register as outsourcing facilities 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 create 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.