On the recordSeptember 28, 2013
I am very pleased that the House is considering today H.R. 3204, the Drug Quality and Security Act. This legislation would address two important issues affecting the quality and security of America's drug supply. First, the bill would protect traditional pharmacies and clarify laws related to human drug compounding in response to last year's nationwide meningitis outbreak--one of the largest public health crises in recent memory. Second, the bill would strengthen the prescription drug supply chain in order to protect American families against counterfeit drugs. As we all remember, in the summer and fall of 2012, a Massachusetts company, the New England Compounding Center, the NECC, shipped over 17,000 vials of an injectable steroid solution from three contaminated lots to health care facilities across the country. After receiving injections of NECC's contaminated steroid, over 64 people died from complications associated with fungal meningitis, and 750 others were stricken with meningitis or other persistent fungal infections. Title I of H.R. 3204 is based off of Representative Morgan Griffith's Compounding Clarity Act and is the culmination of a nearly yearlong House Energy and Commerce Committee investigation. It clarifies FDA's authority over the practice of compounding drugs, and it requires FDA to engage in dialogue with State regulators to prevent against another tragedy like NECC's while protecting the role of traditional pharmacies in compounding.…
Source
govinfo.gov




