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.


Debra Chew: Seeing Millennials Minus The Stereotypes

“Millennials have their own individuality and don’t have to fit into any mold” – that was my response/tweet on the recent #MillennialTalk. The question went something like this:  How can 20somethings thrive at work when there are negative millennial stereotypes within the culture? First, I had to ask myself: what are the negative stereotypes associated with millennials?  ... (click for more)

CHI Memorial Named In Becker’s Hospital Review's "100 Great Community Hospitals" List

Becker's Hospital Review released its 2015 list of “100 Great Community Hospitals” and Memorial Hospital was included.   “We are honored to be named to this prestigious list,” said Rick Napper, CHI Memorial interim CEO. “CHI Memorial’s achievements are made possible through the partnership of our physicians, staff and volunteers who work in tandem to provide exceptional ... (click for more)

Work Set To Restart On Chickamauga Lock This Year

The U.S. Army Corps of Engineers allocated $3 million that Congress provided for fiscal year 2015 to restart construction on Chickamauga Lock this year, Senator Lamar Alexander and Rep. Chuck Fleischmann announced. “We need to replace Chickamauga Lock before it fails, and I talked with Secretary Darcy today to thank her for making this project a priority by deciding to restart ... (click for more)

Boyd Asks Coppinger For Public Apology; Does Not Get One

County Commissioner Tim Boyd on Wednesday morning read a letter in which he asked County Mayor Jim Coppinger for a public apology. However, he did not get one. Instead, County Mayor Coppinger called remarks last Wednesday by Commissioner Boyd that the county mayor had $4.4 million in discretionary funds "ridiculous." He said that money includes such items as the Humane Educational ... (click for more)

Police Need To Stop The Road Cowboys - And Response

Where is our highway patrol?  If they were known to regularly patrol our interstate highways through our city I don't think it would take long before the "truckers" were aware of it.  There are places in our country where this is the case.   When I have traveled Interstates 24 and 75 I may see the occasional car pulled over but rarely if ever is it an 18-wheeler. ... (click for more)

Roy Exum: Never Disturb The Dead

I’ve got too many things in my life that scare me so I’ve always been real leery of “unnecessary fear.” A guy named Terry wanted to teach me how to catch a live rattlesnake one time but had a tough time telling me what exactly to do with the angry serpent when the time came to let it go. I have the same view of these paranormal societies where otherwise sane people go around looking ... (click for more)