A new U.S. Congressional bill that would help ensure the safety of compounded drugs and the nation’s pharmaceutical supply chain deserves support, said U.S. Rep. Frank J. Pallone Jr., D-N.J., the top Democrat on the House Energy and Commerce Health Subcommittee.
Pallone co-authored the bipartisan Drug Quality and Security Act or H.R. 3204, which was developed partly in response to last year’s meningitis outbreak in Massachusetts caused by contaminated compounded drugs mixed at the New England Compounding Center, which killed 64 people and sickened 750 more, said Pallone in a release.
He called those events “tragic.”
“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,” Pallone said. “This legislation will allow (U.S. Food and Drug Administration) to require higher standards for certain drugs and better protect the public health.”
Compounding pharmacies mix drugs tailored to specific patient needs. This legislation clarifies current federal law regarding traditional pharmacy compounding to apply a uniform standard nationwide, according to the release.
Compounders will have the opportunity to register as outsourcing facilities subject to oversight by the U.S. Food and Drug Administration 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 bill also would create a 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 U.S. which means drugs that are stolen or counterfeit may not be discovered before reaching consumers, Pallone said.