Alexander Compounding Legislation Signed Into Law

To Help “Prevent Another Nightmare Like Last Year’s Terrifying Meningitis Outbreak”

Wednesday, November 27, 2013

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.


Tennessee Human Rights Commission Releases Status Of Human Rights In Tennessee Report

The Tennessee Human Rights Commission released The Status of Human Rights in Tennessee Report on Friday at the commission board meeting. The Status of Human Rights Report is a compilation of testimony from the Spring 2014 hearings conducted in Nashville, Chattanooga, Knoxville, and Memphis. The testimony presents current issues, trends best practices,programs, possible solutions, ... (click for more)

Mark Crago Joins CHI Memorial Medical Group

CHI Memorial Medical Group announced that Mark Crago, M.D. has joined CHI Memorial Family Practice Associates Ooltewah. Dr. Crago is a graduate   Uniformed Services University, Bethesda, MD. He completed his residency at Tripler Army Medical Center, Honolulu, HI. "We are pleased to welcome Dr. Crago," said Nicholas G. Economides, M.D., vice president and physician ... (click for more)

Ladaquis D. Southers, 29, Arrested In Connection With Murder Of Terrence Bivens

Ladaquis D. Southers, 29, has been arrested in connection with the homicide of 28-year-old Terrence Lebron Bivens. Southers was arrested in Atlanta by the U.S. Marshals Southeast Regional Task Force on Friday.  He is awaiting extradition back to Hamilton County.  He will be charged with criminal homicide and unlawful possession of a firearm. The victim ... (click for more)

Grote Hall At UTC To Reopen Tuesday After Sinkhole Is Deemed To Pose No Danger

Grote Hall at UTC will reopen on Tuesday after a thorough inspection determined that a sinkhole posed no danger. The campus building was closed on Monday with all classes cancelled. But classes are back on for Tuesday and employees are to report. Officials said the sinkhole was caused by a broken section of stormwater piping that serves the nearby Holt Hall. It was found ... (click for more)

When Black Friday Comes

So it’s Thanksgiving morning. You stumble out of bed and head to the bathroom to pee. Push the handle and away it goes (where does it go, anyway?) Better head to the kitchen and get the coffee on. While it’s brewing maybe a hot shower – love that gas water heater, I mean, it heats the water, and lots of it. Now time to enjoy a cup o’ joe and some breakfast while catching up with ... (click for more)

Roy Exum: UVa --Time For Change

The University of Virginia is, by any measure, one of the finest universities in the world. I have long admired it, whether covering dozens of sports events, cavorting with countless friends, or benefitting repeatedly from the surgical skills of the late world-class humanitarian Frank McCue. But today there is a terrible pall over “Mr. Jefferson’s university” – no, make that a ... (click for more)