If a product's transaction history has a whited-out transaction and the supplier will not reveal the trading partner because it is proprietary, what should you do?

• A. Quarantine the product and report the product as suspicious to the FDA within 24 hours
• B. Return the product to the supplier
• C. Open a query and wait for a response
• D. Proceed with the shipment as is

Answer: (A)

When chain-of-custody information is incomplete and you cannot identify the trading partner, the immediate priority is patient safety and safeguarding the supply chain. This situation triggers regulatory safeguards under DSCSA: you must quarantine the product and report the suspicion to the FDA within 24 hours. quarantining means isolating the item from sale and distribution, preserving it for investigation, and documenting the missing or obscured traceability. Reporting to the FDA quickly helps authorities verify legitimacy and take action if needed, preventing potentially counterfeit or adulterated product from reaching patients.

Waiting for a vendor response or simply querying the partner delays action and can allow suspect product to circulate; returning the product to the supplier doesn’t resolve the lack of verifiable provenance and may not be feasible or safe under regulatory expectations. Proceeding with shipment is not acceptable when you cannot verify the product’s origins. The proper safe-path is to quarantine and file the appropriate report within the mandated timeframe.