Some medicines need to be kept in a refrigerator to maintain their quality and stability.
If a medicine label says “Refrigerate,” it means the product should be stored within the temperature range specified on its label or prescribing information.
The exact storage requirements can vary from one medicine to another.
Why Do Some Medicines Need Refrigeration?
Medicines can be affected by temperature.
For certain products, exposure to temperatures outside the recommended range may affect their stability, strength, or quality.
FDA explains that expiration dates and storage conditions are supported by stability testing designed to show that a medicine will continue to meet appropriate standards throughout its shelf life when stored as directed.
What Temperature Does “Refrigerated” Mean?
Do not assume that every refrigerated medicine has exactly the same storage instructions.
Many refrigerated medicines specify a range such as 2°C to 8°C (36°F to 46°F), but the instructions for the individual product should always be followed.
The medicine label, package insert, or pharmacy label may provide the exact temperature range.
Should Refrigerated Medicine Be Frozen?
Usually not unless the product specifically requires freezing.
Some medicines can be damaged if they freeze.
A label may include instructions such as:
- Do not freeze
- Protect from freezing
- Discard if frozen
These instructions are product-specific, so always check the actual label.
Where Should Medicine Be Stored in the Refrigerator?
Keep refrigerated medicine in a location where the temperature is reasonably stable.
Avoid placing it directly against a freezer compartment or another area where it could accidentally freeze.
It is also important to keep medicines away from children and pets.
If the product came in special packaging, keep it in that packaging unless the instructions say otherwise.
Can Refrigerated Medicine Be Kept at Room Temperature?
Sometimes, but only if the specific product labeling allows it.
Certain refrigerated medicines may remain stable at room temperature for a limited amount of time after dispensing or first use.
Other products may need continuous refrigeration.
Do not apply the storage rules from one medicine to another.
What If You Accidentally Leave the Medicine Out?
Do not automatically use it or throw it away.
Whether a medicine can still be used depends on factors such as:
- Which medicine it is
- How long it was outside the refrigerator
- The temperature it was exposed to
- Whether it was exposed to direct heat or sunlight
- Whether the product has been opened
A pharmacist or the manufacturer can help determine whether the medicine is still appropriate to use.
What If the Refrigerator Loses Power?
Try to keep the refrigerator closed as much as possible while the power is out.
Opening the door repeatedly can cause the temperature inside to rise more quickly.
After power is restored, check the specific medicine’s storage requirements before deciding whether to continue using it.
If you are uncertain how warm the medicine became or how long it was outside the recommended temperature range, contact a pharmacist or the product manufacturer.
Does Proper Storage Affect the Expiration Date?
Yes.
FDA explains that an expiration date reflects the period during which a medicine is expected to remain stable when it is stored according to its labeled conditions.
Improper storage may affect a medicine even if the printed expiration date has not yet passed.
Should You Follow the Pharmacy Label or the Original Package?
Follow the storage instructions provided for your specific medicine.
Prescription labeling includes a section for storage and handling conditions, including requirements such as refrigeration or protection from light.
If instructions on different parts of the packaging appear confusing or inconsistent, ask your pharmacist before changing how you store the medicine.
When to Ask a Pharmacist
Ask a pharmacist if:
- You are not sure whether the medicine needs refrigeration
- The medicine was accidentally left at room temperature
- The medicine may have frozen
- Your refrigerator lost power
- You are traveling with a refrigerated medicine
- You are unsure how long the product can remain outside the refrigerator
- The storage instructions are difficult to understand
Bottom Line
“Refrigerate” means the medicine needs to be stored according to a specific refrigerated temperature range listed in its labeling.
Do not assume that all refrigerated medicines have the same requirements.
Follow the storage instructions for the individual product, avoid freezing unless specifically directed, and ask a pharmacist if the medicine has been stored outside the recommended conditions.
Sources
- U.S. Food and Drug Administration (FDA) — Frequently Asked Questions about Labeling for Prescription Medicines.
- U.S. Food and Drug Administration (FDA) — Expiration Dates — Questions and Answers.
- U.S. Food and Drug Administration (FDA) — The Over-the-Counter Drug Facts Label.