A Suspect Tote, a Broken Seal, and a Thursday Infusion

They are "suspect product." A product is suspect when you have credible evidence it is potentially counterfeit, diverted, stolen, contaminated, or otherwise illegitimate. Broken tamper seal + lot numbers that do not match the transaction information + a trading partner whose license you cannot verify is more than enough.

Required steps:

1. Quarantine immediately - physically segregated, flagged in inventory so it cannot be selected, clearly labeled "do not dispense - suspect product."
2. Do not return them to the supply chain as saleable product. Suspect product does not go back on a truck and get resold; that is how illegitimate product re-enters distribution.
3. Investigate: reconcile the lot numbers against the TI/TS, confirm the secondary distributor's licensure directly with Connecticut DCP, and contact your primary wholesaler's compliance/quality group in writing - not just the sales representative.
4. If determined illegitimate: notify FDA (Form 3911) and immediate trading partners within 24 hours, and document the notification. Also notify the state if an unlicensed entity appears to be distributing in Connecticut.
5. Do not dispense to the waiting patient. Communicate the delay and source elsewhere; a 24-hour delay is a quality event, not an emergency that justifies releasing unverified product.

Not automatically, and not today on this record. The four matching vials were in the same tote with the same broken seal and the same unverified intermediate distributor. Lot-number agreement only tells you the paperwork matches for those units; it does not resolve the broken seal or the licensing question, both of which taint the shipment.

To release them you would need:

• Complete, accurate transaction information, transaction history, and transaction statement for those units.
• Successful verification of the secondary distributor's licensure.
• A documented investigation conclusion that the seal breach did not affect these units.
• Product identifier verification as required for suspect product before further distribution.

That is a same-day investigation at best. The real-world answer: do not dispense Thursday from this shipment. Source the drug from another authorized trading partner, or defer therapy with the prescriber's agreement. The cost of a delayed infusion is a phone call; the cost of an illegitimate oncology drug reaching a patient is not measurable in dollars.

Transaction records: the full T3 set - transaction information, transaction history, and transaction statement - for every receipt and disposition, in electronic, interoperable, retrievable form. Retention: six years under DSCSA.

Suspect-product file:

• Date/time the product was identified and quarantined.
• Photographs of the broken seal; copies of the ASN and the mismatched lot documentation.
• The EPCIS data and the licensure lookup result (screenshot with date).
• A chronological log of every contact: representative, wholesaler compliance, distributor, FDA, state board, prescriber.
• The determination made, by whom, and the basis for it.
• If illegitimacy was confirmed: the FDA notification, the 24-hour trading-partner notifications, and the disposition of the product.

If any unit was dispensed before the problem was found: a patient-level traceability list, prescriber notification, recall/quarantine execution record, and a plan for patient follow-up - the six-year clock then covers the recall file too.

Store it so it can be produced on demand at inspection, not reconstructed after the fact. A quarantine log written the next morning is worth very little.