Mikulski Applauds Senate Passage of Drug Quality and Security Act

Press Release

U.S. Senator Barbara A. Mikulski (D-Md.), a senior member of the Senate Health, Education, Labor and Pensions (HELP) Committee, today announced Senate passage of the bipartisan Drug Quality and Security Act, which will improve regulation of compounding pharmacies and strengthen the security of our drug supply chain. This legislation includes provisions to improve the quality and safety of our nation's compounded drugs and improve our ability to track and trace contaminated drugs.

"The actions by one compounding pharmacy in Massachusetts, the New England Compounding Center (NECC), left 64 people dead from fungal meningitis. In my own state of Maryland there have been 26 confirmed cases and three deaths," Senator Mikulski said. "These deaths and illnesses were entirely preventable.

"The legislation we passed will save lives. It is bipartisan, achievable, affordable and doable. It provides the Food and Drug Administration (FDA) with the authority to regulate large-scale compounding pharmacies and it provides patients with more reliable and comprehensive information about the drugs they're taking. Further, the bill replaces our nation's patchwork of drug tracing laws and implements a strong, uniform, electronic drug tracing system for the entire country. This bill meets compelling human need and puts into place important safeguards to ensure the safety and security of our drug supply chain."

The legislation was crafted after last year's deadly meningitis outbreak, which was caused by contaminated compounded drugs from the New England Compounding Center makes. It makes two major changes that will help prevent another NECC-like tragedy from happening again.

First, it will give the Food and Drug Administration (FDA) the authority to regulate large scale compounding pharmacies. Compounders wishing to make large volumes of these drugs will be required to register, report adverse events and be subject to risk-based inspections by FDA. Smaller traditional compounding pharmacies will continue to be regulated by State Boards of Pharmacy. It will also give patients and providers better information about compounded drugs.

Second, the legislation replaces the current state by state patchwork product tracing laws with a strong, uniform, electronic way to track the drugs back to their source and get them off the market in the event of a problem such as contamination. This legislation will improve patient safety by replacing the state by state patchwork with a strong, uniform standard that will lead to an electronic, interoperable product tracing system for the entire country.

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