Are Over-The-Counter (OTC) Medicines Exposed To Extreme Temperatures Still Safe To Use?
Have you ever left your OTC medicine in a hot car and then wondered if it was still safe to use? The answer may depend on the safe storage instructions listed at the bottom of its Drug Facts label. If you think that your medicine was exposed to conditions outside of the recommended storage instructions, then the safest thing to do is to discontinue use of that medicine and replace it with a fresh supply. Although it is unlikely that medicines will become harmful from heat, cold, or moisture, they may become less effective if exposed to extreme conditions.
Why is it important to keep your medicines from getting too hot or cold?
The majority of OTC medications are designed to be stored in their original packaging at approximately room temperature (68 – 77 degrees Fahrenheit) at an average air moisture level (relative humidity of 35-45%). Their ingredients remain active and unchanged from the time of manufacturing (so long as these conditions are met) until the expiration date featured on the packaging.
OTC manufacturers are held to high safety and quality standards by the Food and Drug Administration (FDA). Products are tested extensively for stability under various environmental conditions, and they have been scientifically proven to retain their original properties when kept under the conditions listed on their Drug Facts label throughout their shelf life.
What quality testing is required by the FDA for OTC medications?
The FDA requires OTC manufacturers to test samples of their product for the duration of the product’s shelf life. Products are subjected to temperatures and humidity levels within the recommended ranges on the Drug Facts label, and then tested to ensure it continues to meet its product specifications. This provides evidence that the product’s active and other ingredients are stable under storage conditions and that there is no growth of unwanted mold or bacteria.
The FDA also requires OTC manufacturers to subject their products to “stress testing.” Stress tests expose the product to temperatures, light conditions, or moisture levels outside of the recommended storage conditions. Samples are taken at regular intervals to evaluate the drug. If there are any concerns about the drug’s safety under these conditions, it is further evaluated.
The bottom line is that OTC products are safe and effective when stored according to the ideal conditions listed on the Drug Facts label. They are unlikely to be harmful if they are exposed to high and low temperatures or excessive moisture, but there is no guarantee that they will be effective.
How can I keep my OTC medicines stored safely at home?
One of the most important things to keep in mind about OTC products is that they are packaged to keep them stable as tested. If you remove the medicine from its original packaging then it is more vulnerable to changes in the environment. The plastic wrap, containers, caps, and moisture-absorbing materials are all designed to protect the drugs from breaking down or changing. If possible, you should always keep OTC products in their original packaging.
When you buy an OTC product, take a look at its Drug Facts label. Safe storage instructions are usually listed at the bottom of the label in the “Other Information” section. Note if the medicine is best stored at room temperature, or if it’s to be kept out of the light, and away from moisture. Think about where it would be best to keep the medicine, especially out of reach of young children. Common mistakes include storing medicines on top of the refrigerator (where heat from the motor can create a hot surface), in the bathroom (where moisture levels are unusually high), and inside the refrigerator (that is too cold for “room temperature” storage.)
How do I keep my medicines from being exposed to extreme temperatures and conditions when I’m traveling?
- Air Travel
The best way to ensure that your medications will not be exposed to extreme environmental conditions is to carry them with you during your flights.
Unlike the comfortable, climate-controlled cabin, airplane cargo may be exposed to more extreme temperatures. So even if the airline reports that their cargo hold (where luggage is stored) is climate controlled, it’s possible for temperatures and pressures to fall outside the range recommended for safe OTC product storage.
- Car Travel
Believe it or not, it doesn’t have to be that hot outside for a car to become an oven. The Weather Channel reports that when the outside temperature is 90º F, a car’s interior can become a whopping 138ºF within 90 minutes. Therefore, it’s rarely a good idea to leave medicines in the car, even for a short period of time. When traveling, keep your medicines inside the climate-controlled portion of the car’s interior (not the trunk) and remember to take your medicines with you if you’re parking your car overnight.
- Mailing Your Meds
Sometimes it’s the medicines that travel, not us! Pharmacies use climate-controlled transportation methods to ensure that the OTC products on their shelves have not been exposed to extreme conditions. The same is not necessarily true for delivery services such as the US Postal Service, UPS, and FedEx. So if you’re shipping your medicines via a courier or mail service, keep in mind that your package could be sitting outside for an extended period of time. In the summer and winter that could mean very high or low temperatures.
The storage of OTC medicines is an often overlooked, but very important part of safe drug use. A quick look at the medication’s Drug Facts label will provide guidance for storage. Although the FDA requires extensive testing of OTC medications, they are not impervious to damage from extreme changes in temperature and moisture. Maintaining OTC products (in their original packaging) in a cool, dry, place away from small children, can go a long way to ensure that they will be safe and effective for the duration of their shelf life.
If you think that your medicines have been exposed to extreme temperatures or conditions, my bottom line is always, “When in doubt, throw it out.”* A fresh package of OTC medicine offers more than safety and efficacy assurances, but peace of mind.
*Please check out the FDA’s recommendations for disposing of medicines safely.