The DSCSA of 2013 amended the FDCA to enhance safety by mandating development of what?

• A. A national patient registry
• B. A national track-and-trace electronic system for prescription medications
• C. A recall committee with independent authority
• D. A standard labeling format

Answer: (B)

The main idea here is ensuring every prescription medicine can be tracked as it moves through the supply chain to protect patients. The DSCSA added a requirement for a national track-and-trace electronic system for prescription medications. This system makes it possible to see where a drug came from, where it’s been, and where it’s going, by exchanging traceability data among manufacturers, wholesalers, and pharmacies. It supports serialization and faster, more precise recalls by pinpointing exactly which products are implicated and where they are in distribution, helping to root out counterfeit or illegitimate drugs.

Other options don’t fit because a national patient registry is about patient health records, not drug distribution safety; a recall committee with independent authority isn’t what DSCSA mandated; and while labeling standards matter, DSCSA’s safety enhancement centers on the ability to track and verify products end-to-end rather than just changing labeling formats.