The Friday 4:50 Delivery
At 4:50 p.m. on a Friday a wholesaler driver delivers five line items and asks the technician to sign so he can leave. Line 2: 3 of 30 glass bottles are broken and the tote floor is wet. Line 3: 12 vials of a refrigerated biologic arrive in an intact carton, but the electronic data logger inside reads 11.4 °C for about 3 hours; the label requires 2–8 °C. Line 5: the transaction statement covers only four of the five lines, and the invoice shows only an NDC and quantity for line 5 - no transaction information accompanies it. A coworker says, "Sign it complete so he leaves. Nothing gets dispensed before Monday anyway - we'll sort it out then."
1. Do you sign the delivery document clean? What do you record at the dock, and what happens before the driver leaves?
Read the worked answer
Never sign a clean receipt over known exceptions.
What to do before the driver leaves:
- Write the exceptions on the delivery receipt/BOL in plain language: "Line 2 - 3 of 30 broken, visible glass, tote wet"; "Line 3 - data logger excursion, product held/quarantined"; "Line 5 - received but not accepted, TI missing." Initial and date each note.
- Photograph the damage, the wet tote, and the data logger display; retain the printed/downloaded logger record - it is the evidence for the claim and for the manufacturer's stability determination.
- Separate and label: damaged goods in the damage/claim area (do not discard packaging - the supplier may want it), line 3 in a Do Not Dispense quarantine, line 5 in a separate documentation-hold location.
- Notify the wholesaler's customer service the same day (email so it is timestamped) rather than Monday.
Signing "complete" converts a supplier-side loss into a pharmacy-side loss and, for line 5, puts product into inventory without the DSCSA documentation that authorizes it to be there.
2. What is the disposition of the 12 vials that saw 11.4 °C for roughly 3 hours?
Read the worked answer
An excursion is a question, not an automatic destruction - and not an automatic release.
- Quarantine immediately with a hold tag; the vials do not go into the refrigerator with saleable stock until a determination is documented.
- Contact the manufacturer (not just the wholesaler) with the specifics they will ask for: temperature reached, duration, number of excursions, current lot, and cumulative time out of range. Acceptability is set by the manufacturer's stability data for that product, not by a rule of thumb, and cumulative exposure across the product's life matters.
- Get the determination in writing and file it with the receipt. Record who authorized release and on what basis.
- If the manufacturer will not support release, return for credit/replacement; do not dispense to avoid a stockout, and do not "use it if the patient really needs it."
- Separately, close the loop on cause: was the shipment packed with enough gel packs, was it left on the dock, was it on the truck too long? Repeat excursions from one lane are a supplier-qualification issue.
3. Line 5 arrived with a transaction statement but no transaction information for that item. Can it be received and dispensed?
Read the worked answer
No - documentation is the condition of lawful possession, not paperwork to chase later.
- DSCSA requires transaction information, transaction history, and the transaction statement for the product before it can be accepted into saleable inventory. A TS covering four of five lines does not cover line 5.
- Hold the product in a segregated, labeled location; do not shelve it, dispense it, or transfer it to another site.
- Request the missing TI in writing from the wholesaler the same day, with a deadline. If it arrives and matches the product actually received (NDC, strength, quantity, lot, expiration, and the supplier's name/address), release and file it with the receipt, documenting the resolution.
- If it cannot be produced, return the product and document the return. Retain all correspondence.
- If at any point the product looks suspect - mismatched NDC, altered packaging, wrong serial - stop, quarantine, investigate, and follow the illegitimate-product notification path (FDA and trading partners within 24 hours of the determination).