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.

Center For Mindful Living Announces Catalyst 2018

Catalyst 2018, a fundraising event for The Center for Mindful Living, will take place on Wednesday, April 11, at Stratton Hall, 3146 Broad St. Doors will open at 5:30 p.m. The evening will include food from local catering company Dish T’Pass as well as wine and a signature cocktail. The event will raise money for the Center’s ongoing outreach programs in Hamilton County Schools ... (click for more)

Morning Pointe Prepares For March 26 Cornhole Championship Game

The Morning Pointe of Chattanooga assisted living and Alzheimer's memory care communities are advancing to the first annual Cornhole Championship Game, taking place at Grace Baptist Academy, 7815 Shallowford Road, on Monday at 5 p.m.    After more than 10 weeks, the residents at all five Morning Pointe communities in Chattanooga, Collegedale and Hixson have ... (click for more)

Sheriff Hammond Says $4 Million Needed To Put SROs In All Hamilton County Schools

Sheriff Jim Hammond on Thursday night told members of the County School Board that $4 million is needed to provide School Resource Officers for all of the 79 schools. He said currently there are 31 SROs in 29 schools, leaving 50 uncovered. School Board member Rhonda Thurman said she believes the community could come together to provide the necessary funding. "It's something ... (click for more)

Judge Philyaw Denies He Did Not Reappoint Magistrate Because She Was Gay

Juvenile Court Judge Rob Philyaw told a federal jury on Thursday that the fact Elizabeth Gentzler is openly gay had no part in his decision not to reappoint her as a magistrate. "Absolutely not. I have a lot of gay friends, family and acquaintances," he said. However, a court officer at Juvenile Court sided with Ms. Gentzler. Jimmie Cannon said, "Ninety-nine percent ... (click for more)

Tax All County Property Owners Once For School Safety

Our School Board, Sheriff Hammond, school administrators and the community are thoughtfully considering how to maintain safety in classrooms. Currently, discussions indicate more funding will be needed to ensure school safety. If schools are not safe and more money will change that, by all means let’s move to fix the problem.   There are many caring and knowledgeable ... (click for more)

Roy Exum: ‘In God We Trust …And Protecting Our School Children

On a day that the Tennessee Legislature overwhelmingly approved a bill that would prominently display the words “In God We Trust” in every school building in the state, the Hamilton County School Board gave my boy Bad Little Johnny cause to get a magic market and scribble underneath, “but ‘Everybody Else Is Gonna’ Need A Pistol!’” Hamilton County Sheriff Jim Hammond, who was ... (click for more)