Bill Status:
Passed by House
Last Action:
Sep 28, 2013
H.R. 3204,
the "Drug Quality and Security Act," helps ensure the safety of
compounded drugs and our nation’s pharmaceutical supply chain. The
legislation introduced by Committee Chairman Upton and cosponsored by
Committee members Reps. Waxman, Pitts, Pallone, Murhpy, Dingell, Latta,
DeGette, Griffith, Green, and Matheson, 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's investigation into drug compounding initiated in October 2012 when it sought investigative information from the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). This information, subsequent hearings, and document retrieval helped to illustrate the need for a bill such as H.R. 3204, which safeguards public health and protects the integrity of our pharmaceutical system.
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.
The Committee's investigation into drug compounding initiated in October 2012 when it sought investigative information from the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). This information, subsequent hearings, and document retrieval helped to illustrate the need for a bill such as H.R. 3204, which safeguards public health and protects the integrity of our pharmaceutical system.
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.
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