A wholesale shipment of atorvastatin tablets, lot ATV-7741, arrives at a community pharmacy. While reconciling the delivery, a technician finds that the supplier did not send the accompanying transaction information and transaction statement for several cartons in the order. Under DSCSA, what is the technician's correct next step before these cartons are placed into sellable stock?
- APlace the cartons into sellable stock and request the missing transaction documents from the supplier within 30 days.
- BHold the cartons as not received and decline to accept ownership until the transaction information and transaction statement are supplied. Correct
- CDestroy the cartons immediately because product lacking transaction documents is automatically counterfeit.
- DRepackage the cartons under the pharmacy's own lot number so they can be dispensed normally.
Why A is wrong: This is tempting because contacting the supplier is appropriate, but DSCSA prohibits accepting ownership of product without the required transaction data, so the product cannot enter sellable stock first.
Why B is correct: DSCSA requires that a dispenser receive the transaction information and transaction statement before or at the time of taking ownership, so product without that data must not be accepted into stock.
Why C is wrong: This overreacts: missing paperwork is a transaction-data failure, not proof of counterfeiting, and DSCSA does not direct immediate destruction without investigation.
Why D is wrong: Relabelling tempts those who think a new lot number solves the gap, but dispensers may not generate substitute transaction data, and this would break the chain of traceability DSCSA requires.