This is a ready-to-use disposition record for a returned medicinal product, the decision that cannot be undone once a returned unit is mixed back into saleable stock. It applies the same evidence-first gate used for transit temperature excursions: confirm the record is trustworthy before asking whether the product looks acceptable. Replace every <<FILL: ...>> placeholder with your own specifics. A worked specimen follows. This is general guidance to adapt to your own procedures and applicable national requirements, not legal advice.
Instructions
Complete one record per return, or per return lot if multiple units from the same customer, same dispatch, and same condition history are returned together. No return may be placed into saleable stock without a completed, RP-approved record.
Field table
| Field | Format | Required | Completed by | When |
|---|---|---|---|---|
| Return record number | <<FILL: RET-ID>> | Yes | Receiving | At receipt |
| Product, strength, lot/batch, expiry | Free text | Yes | Receiving | At receipt |
| Quantity returned | Number | Yes | Receiving | At receipt |
| Returning party | Name, and whether they hold a wholesale/manufacturing authorization | Yes | Receiving | At receipt |
| Original dispatch date | Date | Yes | Receiving (from distribution record) | At receipt |
| Date received back into company control | Date | Yes | Receiving | At receipt |
| Days elapsed since dispatch | Calculated | Yes | Receiving | At receipt |
| Within standard reconsideration window? | Yes / No, per your procedure’s defined window | Yes | Receiving | At receipt |
| Packaging condition | Intact / damaged, with description if damaged | Yes | Receiving | At receipt |
| Safety features verified (unique identifier, anti-tampering device) | Verified authentic / verification failed / not applicable | Yes | Receiving | At receipt |
| Storage-condition evidence for the return-transit period | Attached (logger record, reference number) / Not available | Yes | Receiving | At receipt |
| Evidence source and calibration status, if attached | <<FILL>> | Yes if evidence attached | Cold-chain SME | Before disposition |
| Reason for return | Free text | Yes | Receiving | At receipt |
| Risk assessment reference, if outside standard window | <<FILL: RA number, or N/A>> | Yes if outside window | Quality assurance | Before disposition |
| Disposition | Return to saleable stock / Quarantine pending further assessment / Reject, destroy or return to MAH | Yes | Responsible Person / Quality head | Before any stock movement |
| Disposition rationale | Free text, must address every “No” or “Not available” answer above | Yes | Responsible Person / Quality head | Same step |
| RP / quality approval (name, signature, date) | <<FILL>> | Yes | Responsible Person / Quality head | Before the product moves |
Retention
Retain with the returns register per the records retention schedule, for not less than <<FILL: retention period>>.
Filled specimen
Completed for the returns worked example used in the parent article: a hospital pharmacy returns three unopened cartons of a biologic four days after dispatch, using their own unmonitored courier.
| Field | Entry |
|---|---|
| Return record number | RET-2026-0071 |
| Product, strength, lot/batch, expiry | Biologic Alfa 50 mg/mL, Lot BX4471, exp 2027-11 |
| Quantity returned | 3 cartons |
| Returning party | Community Hospital Pharmacy; does not hold a wholesale distribution authorization |
| Original dispatch date | 2026-08-14 |
| Date received back into company control | 2026-08-18 |
| Days elapsed since dispatch | 4 |
| Within standard reconsideration window? | Yes |
| Packaging condition | Intact, no visible damage |
| Safety features verified | Verified authentic |
| Storage-condition evidence for the return-transit period | Not available; returning pharmacy used their own courier with no logger |
| Evidence source and calibration status | N/A, no evidence supplied |
| Reason for return | Ordered in error, product not needed |
| Risk assessment reference | N/A, within standard window |
| Disposition | Reject, destroy per waste procedure |
| Disposition rationale | Packaging and safety features are clean and the return is within the standard four-day window, but there is no storage-condition evidence for the return-transit leg. The thermal history cannot be confirmed, so the product does not meet the evidence bar for saleable stock regardless of external appearance. |
| RP / quality approval | R. Gomez, signed, 2026-08-19 |
Common inspection findings this form prevents
- A return placed back into saleable stock on packaging appearance alone, with no attempt to establish storage-condition history.
- No record of who approved the return, or approval recorded after the product had already moved back into stock.
- Safety features not checked, or checked and failed but the return proceeded anyway.
- Returns outside the standard reconsideration window handled the same as routine returns, with no documented risk assessment or individual approval.
- No returns register, so the pattern of rejected versus accepted returns is invisible at management review.
How to adapt this form
- Set your own standard reconsideration window (days since dispatch) per your procedure and applicable national guidance; do not assume a fixed EU-wide number without checking your own competent authority’s implementing guidance.
- Require storage-condition evidence as a hard gate for any temperature-sensitive product; make “not available” default to reject, not to a judgment call.
- Route every disposition through the same named Responsible Person or quality role your procedure designates, and block stock movement until that approval is recorded.
- Feed rejected and accepted returns into the same trend review that covers other distribution data-integrity findings, so a pattern (a specific customer, a specific courier lane) becomes visible.