What do label storage conditions mean?
A medicine's label storage condition comes from stability studies and is set by the marketing authorisation holder; the warehouse keeps it. Each statement, such as 'Store in a refrigerator (2–8 °C)', 'Do not freeze' or 'Do not store above 25 °C', needs a measurable counterpart in the warehouse.
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This content is for information only. It is not a regulatory interpretation, an audit opinion or a storage instruction for your product. The approved label and the current guidance of the competent authority take precedence.
The storage condition on a medicine’s carton or leaflet is not the manufacturer’s preference. It comes from stability studies, which show how long the product stays within specification at different temperatures and humidities, and it is set by the marketing authorisation holder. A warehouse cannot change that condition; it can only keep it. This article explains what the most common label statements mean on the warehouse floor.
Why there are standard statements
The European Medicines Agency’s guideline on the declaration of storage conditions defines the standard wording used in product information: “Do not store above 25 °C”, “Store in a refrigerator (2 °C–8 °C)”, “Do not freeze” or “Store in the original package in order to protect from light”, for example. The aim is that everyone in the chain reads them the same way. The same guideline does not accept vague terms such as “room temperature” or “ambient conditions”, because what they mean changes from one climate to another.
Turkish patient leaflets carry the same ideas: “25 °C’nin altındaki oda sıcaklığında saklayınız” (store at room temperature below 25 °C), “Buzdolabında (2–8 °C) saklayınız” (store in a refrigerator), “Dondurmayınız” (do not freeze).
What they mean in the warehouse
| Label statement | In the warehouse |
|---|---|
| Do not store above 25 °C | The area’s upper limit is 25 °C, monitored continuously. |
| Store in a refrigerator (2–8 °C) | The product sits in a cold room or a pharmaceutical refrigerator; below 2 °C is a deviation too. |
| Do not freeze | The lower limit is critical as well; spots in the direct airflow of a cooling unit are not used. |
| Store in the original package to protect from light | The product stays in its outer carton, which matters for work such as kitting. |
| Protect from moisture | Packaging stays intact and areas near sources of damp are not used. |
When the label was written for the US market
The United States Pharmacopeia (USP) defines some terms with numbers. Controlled room temperature is 20–25 °C, with excursions between 15 and 30 °C allowed in pharmacies, hospitals and warehouses. “Cool” is 8–15 °C, “refrigerator” 2–8 °C and “freezer” between −25 and −10 °C. These definitions help when reading labels written for the US. On European and Turkish labels, the range printed on the label itself is what counts.
When the condition is not met
A warehouse keeps the label condition by measuring continuously at points chosen through temperature mapping. We describe how mapping is done in a separate article. If the records show the condition was not met, the goods are quarantined and the marketing authorisation holder is informed. Whether the product can still be used is decided by the marketing authorisation holder, based on stability data, not by the warehouse. Temperature excursions in transport are assessed on the same principle.
Sharing the label condition before storage starts settles early on whether a warehouse can meet it.
References
- European Medicines Agency, Guideline on declaration of storage conditions: A: in the product information of medicinal products, B: for active substances (CPMP/QWP/609/96/Rev 2)
- United States Pharmacopeia, General Chapter <659> Packaging and Storage Requirements
Information only; not a regulatory interpretation or a storage instruction.