The Senate today passed the Drug Quality and Security Act (H.R. 3204) by voice vote. The compounding and track-and-trace bill now heads to President Barack Obama and he is expected to sign it.
H.R. 3204 passed the House by voice vote in September. APhA backs the legislation and wrote a letter supporting the bill after months of work with the House and the Senate, wrote APhA Executive Vice President and CEO Thomas E. Menighan, BSPharm, MBA, ScD (Hon), FAPhA, on his CEO Blog on pharmacist.com today.
According to news reports, the compounding legislation would create “outsourcing facilities”; pharmacies conducting large-scale compounding of sterile drugs would voluntarily register for FDA oversight; and FDA could conduct risk-based inspections of such facilities.