The measure would apply uniform national standards to pharmacy compounding while enacting a track-and-trace system to ensure the safety of drugs throughout the supply chain.
The Hill: Lawmakers Strike Agreement On Compounding Pharmacy Regulation
Health policy leaders in the House and Senate announced an agreement on legislation to strengthen regulation of non-traditional compounding pharmacies, which have been tied to several deadly outbreaks in the last year. Lawmakers said the new bill would apply uniform national standards to pharmacy compounding while enacting a track-and-trace system to ensure drugs are safe throughout the supply chain. Currently, a patchwork of state and federal regulations complicates oversight of drug compounders, who either customize medications on a prescription-by-prescription basis or produce drugs in large quantities like a manufacturer (Viebeck, 9/25).
Reuters: U.S. Congressional Panels Agree On Bill To Regulate Drug Compounding
The bill, called the Drug Quality and Security Act, comes in response to a deadly outbreak last year of fungal meningitis that killed more than 50 people and was traced to a tainted steroid sold by the New England Compounding Center in Framingham, Massachusetts. The legislation is expect to pass smoothly and quickly through the full House and Senate (9/25).