What is the DSCSA’s track-and-trace requirement specifically focused on?

• A. Serial number only
• B. Transaction history, transaction information, and transaction statement
• C. Only lot number
• D. Only expiration date

Answer: (B)

The track-and-trace requirement is about ensuring visibility of a drug as it moves through the supply chain by exchanging a complete set of transaction data with every sale. This means three components travel with the product: Transaction Information, which includes details about the product and the parties involved in the shipment; Transaction History, which records the full chain of custody from manufacturer to the current owner; and Transaction Statement, a verification from the seller that the product was distributed in compliance with DSCSA. Together, these elements let pharmacies, wholesalers, and manufacturers trace a product back to its source, verify its legitimacy, and act quickly in recalls or investigations. It’s not just a serial number, or a single data point like an expiration date; the requirement centers on the full TI/TH/TS information set.