Compounding-Drug Bill Clears House

The House of Representatives has passed the Drug Quality & Security Act (H.R. 3204), a bill that gives FDA authority to regulate large-scale compounding pharmacies in the same way it does drug manufacturers. Compounding pharmacies are currently regulated at the state level, whereas drug manufacturers are regulated by FDA. Over the past two decades, some compounding pharmacies, such as the one responsible for the multistate outbreak of fungal meningitis last year, have produced large batches of drugs that are distributed nationwide. Under H.R. 3204, such large-scale compounding facilities would be required to register annually with FDA and be subject to risk-based inspections. The bill would also authorize a uniform system for tracking drugs along the supply chain, from the manufacturer to the pharmacy. Although the measure has support from key Senate leaders, some lawmakers are questioning the effectiveness of the legislation because it doesn’t draw a clear line to define which pharmacies are large scale. It is unclear when the Senate will take up the legislation.