Senator Lamar Alexander, the senior Republican on the Senate health committee, Wednesday praised the signing into law of The Drug Quality and Security Act, a result of a legislative agreement he reached with House and Senate health committee leaders to make injections of compounded sterile drugs safer.
Senator Alexander said, “I have been working with my Senate colleagues for a year to find a solution that would help prevent a repeat of the terrifying meningitis outbreak that has killed 16 Tennesseans and made so many others so sick. Tennesseans deserve this law to make it clear exactly who is in charge of overseeing each compounding facility, so there will be no questions about who’s on the flagpole.”
He added, “This law affects the health and safety of millions of Americans. It is important in Tennessee to those 16 families who had a family member die. It is important to the dozens of families with a member of their family who is sick because of those injections. It is important to those families who may still become sick in our state and other states.”
Last November, when the Senate Health, Education, Labor and Pensions Committee held its first hearing on the deadly meningitis outbreak, Senator Alexander called for a new model of oversight of sterile compounding pharmacies. Senator Alexander and HELP Committee Chairman Tom Harkin (D-Iowa), House Energy and Commerce Chairman Fred Upton (R-Mich.) and Ranking Member Henry Waxman (D-Calif.) announced legislation agreement and the bill was passed by the House on Sept. 28. The bill, cleared by both houses of Congress on Nov. 18, clarifies current federal law regarding pharmacy compounding and resolves the patchwork of current federal regulation by applying a uniform standard nationwide.
The legislation distinguishes compounders engaged in traditional pharmacy practice from those making large volumes of compounded drugs without individual prescriptions. Compounders who wish to practice outside the scope of traditional pharmacy practice can register with the Food and Drug Administration as “outsourcing facilities,” subject to FDA oversight in much the same way as traditional manufacturers. Those who choose to remain traditional pharmacies will continue to be primarily regulated by State Boards of Pharmacy as they are in current law.
It also offers providers and patients better information about compounded drugs, by directing FDA to make a list of FDA-regulated outsourcing facilities available on FDA’s website, requiring detailed labeling on compounded drugs, and prohibiting false and misleading advertising.
The bill also includes legislation to track and trace the more than 4 billion prescriptions that are written in America every year to help ensure their safety, replacing 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 4 billion prescriptions per year in the United States, which means consumers can receive drugs that are stolen, counterfeit, or ineffective.
This legislation requires the entire drug supply chain—including manufacturers, repackagers, wholesale distributors, third-party logistics providers, and dispensers—to pass along transaction information, history, and statements, as applicable, when there is a change of ownership. The last comprehensive effort to establish safeguards for the drug distribution supply chain was 25 years ago with the passage of The Prescription Drug Marketing Act.