Congress Approves Final Version of Compounding Legislation
From AMA's November 27, 2013, Advocacy Update
On Nov. 18, the Senate passed by voice vote H.R. 3204, the “Drug Quality and Security Act.” This legislation, which passed the House on Sept. 28, is expected to be signed by the president shortly. It establishes new FDA regulatory oversight for those who compound sterile drugs, while ensuring that traditional compounding practices continue. Additionally, it strengthens the prescription drug supply chain, protecting Americans against counterfeit drugs. The legislation is a critical step to ensure compounding practices are safe and is expected to prevent future public health crises, such as the meningitis outbreak of 2012.
AMA worked with both the House and Senate to ensure physicians and patients can continue receiving safe compounded drugs, and that the new regulatory framework would not exacerbate drug shortages. AMA also secured assurances from key senators and representatives that the new regulatory framework would not alter current compounding practices, specifically in-office use, and that Congress would act swiftly if unintended consequences occur.