H.R. 3204, the "Drug Quality and Security Act"

On September 27, 2013, House by Energy and Commerce Committee Chairman Fred Upton, Ranking Member Henry A. Waxman, and Reps. Joe Pitts, Frank Pallone, Jr., Tim Murphy, John D. Dingell, Bob Latta, Diana DeGette, Morgan Griffith, Gene Green, and Jim Matheson introduced H.R. 3204, the Drug Quality and Security Act, to ensure the safety of compounded drugs and our nation’s pharmaceutical supply chain.  This bill reflects a bipartisan, bicameral effort to improve drug safety and help prevent a future public health crisis like the 2012 meningitis outbreak tied to the New England Compounding Center.  

The Committee launched an investigation into drug compounding in October 2012 after the Centers for Disease Control became aware of an outbreak of fungal meningitis and other infections among patients who received contaminated steroid injections from the New England Compounding Center in Framingham, Massachusetts.

The bill will correct the constitutional defect in the drug compounding statute of the FDA that has diminished the Agency’s ability to effectively enforce the Federal Food, Drug, and Cosmetic Act for years.  It will also give FDA the opportunity to have broad oversight of a new category of large compounding pharmacies.  Further, it develops a uniform system for tracking and tracing drugs to prevent counterfeits from entering the pharmaceutical supply chain.

H.R. 3204 was signed into law on November 27, 2013, as Public Law 113-54.