A bill to bolster federal oversight of large-scale compounding pharmacies and establish a national prescription drug track-and-trace system is on the way to the president for his signature. The Senate approved the “Drug Quality and Safety Act,” H.R. 3204, by voice vote Nov. 18. It passed the House in September.
The legislation is designed to improve the safety of compounded drugs and the security of the drug supply chain. It would allow facilities that compound sterile drugs to elect to register as “outsourcing facilities” subject to federal oversight by the Food and Drug Administration (FDA) and have their status publicized on the agency’s website.
Registered outsourcing facilities would be required to comply with “current good manufacturing practices” and certain labeling requirements; report adverse events; undergo risk-based inspections by FDA; and pay establishment and reinspection fees. Hospitals and others that choose to remain traditional compounding pharmacies would continue to be primarily regulated by state pharmacy boards as under current law.
The bill also would require improvements in the communication between the states and FDA in the event of problems with compounded drug products produced by traditional compounding pharmacies.
“Track and trace” provisions of the bill would create a system to track most prescription drugs from the manufacturer to the dispenser (such as hospitals and pharmacies) by establishing nationwide drug serial numbers within four years and electronic unit-level tracing within a decade. The bill also would strengthen licensure requirements for wholesale distributors and third-party logistics providers.
Congress passed the legislation 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, MA.