House Passes Alexander Compounding Agreement

Sunday, September 29, 2013

The  House of Representatives has passed a legislative agreement Senator Lamar Alexanderreached with House and Senate health committee leaders to clarify oversight of the nation’s compounding facilities.


Senator Alexander said: “This is a big step toward preventing another nightmare for Tennesseans like last year’s tragic meningitis outbreak, which the FDA commissioner tells us will happen again if we don’t fix the uncertainty over who’s in charge of compounding facilities. The House has passed our agreement 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. I urge the Senate to act swiftly and send this bill to the president to sign.”


Today’s bill represented an agreement by Alexander and Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Tom Harkin (D-Iowa), House Energy and Commerce Chairman Fred Upton (R-Mich.) and Ranking Member Henry Waxman (D-Calif.). The bill clarifies current federal law regarding pharmacy compounding and resolves the patchwork of current federal regulation by applying a uniform standard nationwide.


Last November, when the Senate HELP Committee held its first hearing on the deadly meningitis outbreak, Alexander called for a new model of oversight of sterile compounding pharmacies.

One year ago, the meningitis outbreak caused by contaminated compounded drugs from the New England Compounding Center alerted the nation that providers and patients need sources of safe compounded drugs.  Following the outbreak, a bipartisan group of HELP Committee Senators— led by Chairman Harkin, Ranking Member Alexander, Sen. Pat Roberts (R-Kan.), and Sen. Al Franken (D-Minn.)—developed legislation to help ensure that quality compounded drugs are available to patients who need them.

Among other highlights, 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 as outsourcing facilities, but those who choose to remain traditional pharmacies will continue to be primarily regulated by State Boards of Pharmacy as they are in current law.
  • Defines the Food and Drug Administration’s (FDA’s) role in oversight of outsourcing facilities.  Outsourcing facilities would be subject to FDA oversight in much the same way as traditional manufacturers.  FDA will know who these outsourcers are and what they are making, receive adverse event reports about compounded drugs, and have the authority and resources to conduct risk-based inspections.  The legislation will give providers and patients the option of purchasing products from outsourcing facilities that comply with FDA quality standards.
  • Offers providers and patients better information about compounded drugs.  The legislation directs FDA to make a list of FDA-regulated outsourcing facilities available on FDA’s website, requires detailed labeling on compounded drugs, and prohibits false and misleading advertising.
  • Clarifies current federal law regarding pharmacy compounding.  The legislation strikes unconstitutional provisions in current law, resolving the patchwork of current federal regulation and applying a uniform standard nationwide.


The bill is supported by the Tennessee Pharmacists Association, who stated: "We believe this compromise proposal offers an effective approach to address complex issues surrounding compounded medications by having the Food and Drug Administration (FDA) focus on entities that are compounding outside the scope of traditional pharmacy compounding while leaving traditional pharmacy compounding under the oversight of state boards of pharmacy."

The bill also includes legislation based upon a bill passed unanimously by the Senate health committee that improves patient safety by replacing today’s patchwork of state pharmaceutical drug tracing laws with a strong, uniform standard that would ultimately result in electronic, interoperable unit level drug tracing for the entire country.  The last comprehensive effort to establish safeguards for the drug distribution supply chain was twenty-five years ago.  This bipartisan, bicameral draft is the result of several years of work to address the growing problem of pharmaceutical theft, counterfeiting, and diversion.  

Among other highlights, the legislation:

  • Develops a workable pathway to unit-level tracing in a decade. Over the course of seven years, the major sectors of the pharmaceutical supply chain, such as manufacturers, repackagers, wholesale distributors, and dispensers will all be passing and holding onto key information about each drug’s distribution history.  Within ten years, supply chain stakeholders will participate in electronic, interoperable drug tracing.
  • Strengthens licensure requirements for wholesale distributors and third-party logistics providers.  Wholesale distributors will have higher standards for their licenses nationwide, and third-party logistics providers will be recognized for the first time as a part of the drug supply chain. FDA will also keep a database of wholesalers that will be available to the public through the FDA’s website, allowing consumers and members of the drug supply chain to identify appropriately licensed wholesalers.
  • Establishes nationwide drug serial numbers.  Four years after the date of enactment, manufacturers will serialize drugs in a consistent way across the industry.  This will allow for efficient tracing to respond to recalls and notices of theft and counterfeiting.   

World AIDS Day Events Held Dec. 1 And 6

The Southeast TN Council for HIV/AIDS Care and Prevention, in partnership with the city of Chattanooga and The Hunter Museum of American Art, will host World AIDS Day 2015 events on Tuesday, Dec. 1, and Sunday, Dec. 6. These events will highlight the arc of the pandemic, how the southern United States is the epicenter of the domestic HIV/AIDS epidemic, the ... (click for more)

Free Metabolic Seminars Hosted By CHI Memorial Metabolic And Bariatric Care

Jack F. Rutledge, M.D. and CHI Memorial Metabolic and Bariatric Care will host two free seminars in December on surgical weight loss options. The first seminar will be held at CHI Memorial Hospital in the community room Tuesday, Dec. 1 at 6 p.m. The second seminar will be at the North River Civic Center in Hixson on Tuesday, Dec. 15 at 6 p.m. "Obesity can be devastating to ... (click for more)

City Council To Consider Policy That Job Applicants Would Not Have To Reveal Criminal Records

The City Council on Tuesday night will consider a policy that city job applicants would not have to reveal their criminal past. Councilman Yusuf Hakeem cited problems those with felony records have in securing employment. The policy would go into effect by the first of the year. The resolution says: WHEREAS, the City of Chattanooga (the "City") is committed ... (click for more)

City Considering Measure That Would Require City Employees To Be Tennessee Residents

The City Council is considering an ordinance that would require city employees to be residents of the state of Tennessee. The city has employees who live in North Georgia and North Alabama and that is allowed.  If the ordinance is approved by the City Council, it still would need to be okayed by a majority of city voters in an election. The measure will be considered ... (click for more)

An Extra Helping Of Gratitude

After being thankful for the grace of God, my family and good health, this year I have an extra helping of gratitude to live in a special place called Chattanooga.   We endured the trauma of terrorism on July 16 and emerged more united and stronger than ever before.  We claim our heritage and celebrate our diversity like no other city in America.  We honor our ... (click for more)

Roy Exum: We Can’t ‘Ban The Box’

I know a man who has over 20 former convicts from federal prisons who either work for him or who have retired with their dignity, pride, and self-worth restored. Better yet, I know some of them, men who have done “hard time” in prisons so wretched none of us would dare to go. So on the surface I applaud City Councilman Yusef Hakeem for seeing ways to get formerly incarcerated men ... (click for more)