Drug Manufacturers Get the Anti-Counterfeiting Law They Wanted: Now They Must Meet Deadlines
This article was originally published in The Gold Sheet
November signing of Drug Quality and Security Act into law sets in motion a deadline-packed three-phase process of establishing tracing and serialization requirements for drug products to protect the U.S. market from counterfeits.
You may also be interested in...
U.S. and EU Regulators and Industry Grappling with Track-and-trace Standards to Combat Drug Counterfeiting
Pharmaceutical industry groups and lawmakers in the U.S. and the EU are continuing to grapple with what a pharmaceutical track-and-trace system will look like to thwart drug counterfeiting. The EU has three different track-and-trace models with various levels of traceability in each, while in the U.S., efforts to attach a national traceability system to the user fee legislation failed to garner consensus on the best approach, and meanwhile industry is instituting brand protection programs.
A fresh executive order from US president Joe Biden calls for short-term and long-term study, broad consultation, and co-ordination with allies on the domestic supply chain.
Executive order calls for short-term and long-term study, broad consultation, coordination with allies.