How long a cold chain medicine lasts outside the refrigerator comes from the product's own stability data, so no single hour fits all. The time a medicine stored at 2-8 °C may spend outside is written in sections 6.3 and 6.4 of its summary of product characteristics (SmPC). Three product information texts published by the European Medicines Agency show how far even similar biologicals differ.
| Product | Allowed outside the refrigerator | Freezing |
|---|---|---|
| Humira pre-filled syringe | Up to 25 °C for 14 days, protected from light | Do not freeze |
| Enbrel | Up to 25 °C for a single period of 4 weeks; not refrigerated again afterwards | Do not freeze |
| NovoRapid pen and vial | In use or carried as a spare, below 30 °C for up to 4 weeks | Do not freeze before opening |
These periods are allowances for patient use; they are not an automatic tolerance for an excursion in distribution. The UK SPS guidance notes that a product near the end of its shelf life is more likely to be unsuitable after an excursion, so the excursions a product has already seen also count. Freezing is a separate question: for all three products the first rule is not to freeze, and for a freeze-sensitive product even suspected brief freezing needs assessment.
First action for commercial stock
The affected product is quarantined with a 'do not use' label and kept under its labelled storage conditions until a decision is made. Cooling it again does not reset the clock, and normal appearance does not prove potency. SPS advises that the authorisation holder may hold stability data beyond the SmPC and that this data should be requested for the risk assessment. The outcome is one of three: the product is used with a shortened shelf life, used with additional patient monitoring, or discarded.
The record sent for assessment includes:
- product name, formulation, lot and label conditions
- last good reading, first bad reading and the gap between them
- highest or lowest value and the full temperature profile
- sensor position, box or vehicle, door openings and ambient conditions
- earlier excursions, handover and quarantine records
The first bad reading is not necessarily when the excursion began. With a good reading at 09:00 and a bad one at 13:00, the excursion started somewhere in that interval; four hours of exposure is not proven, and the report states that the start is unknown. An air sensor does not directly show the product's internal temperature either, so sensor position and packaging details go into the record.
Medicines used at home
For personal use, do not judge from the package or appearance; contact a pharmacist promptly. If a dose is due, do not skip or change it on your own; plan continuity with a clinician or pharmacist.