April 21, 2000 (Washington) -- You really do need to take expiration dates on drugs seriously. Why? Because drugs can become unsafe or lose potency over time, and the expiration date is as long as the drug company wants to claim its drug will be safe and have the correct potency.
I was at the FDA when the rule was issued requiring drug companies to test their products to see how long they remained potent and safe, and then to include an expiration date on the product. Until the rule was issued, consumers had no idea when how long they could keep their drugs safely.
At the FDA, we recognized that there clearly was a need for consumers to have some time frames for discarding drugs. All of us -- me included -- have drugs in our medicine chests that have gone beyond the expiration date.
Under the FDA rule, drug companies must test their drugs to be sure they are stable for as long a period as the company wants to claim the expiration date is. So if a drug is made in May 2000 and the company has conducted testing that the drug will remain safe and potent for two years, the expiration date is May 2002. The rule applies to both nonprescription drugs and prescription drugs. Even dietary supplements are putting expiration dates on the bottle.
A little clarification is in order: The testing does not mean that the drug will remain potent for only two years. It means only that the drug has been tested to assure its safety and potency for at least two years. In fact, a drug may be potent for 10 years or more but still have an expiration date that is only two or three years.
The U.S. military has found that many drugs stored in their facilities lasted much longer than their expiration dates. The reason is that their drugs were stored under ideal conditions. Not many of us truly can keep our drugs stored in a cool, dry place without being moved for years on end.
The experience with the U.S. military's drugs underscores why you should take expiration dates seriously: You don't store your drugs under ideal circumstances, as the military does.
You probably store some drugs in your bathroom, where they get moist when you take a shower or bath. Or you may store some drugs in your kitchen, where the stove gets hot, or on the windowsill, where the sun hits them.
Under these circumstances, it is not likely that drugs stored will become outright unsafe, but they could easily lose potency, which means they won't be as effective as they should be.
Health is too important to chance. You want your drugs to work as they should. That's why it's so important to store drugs properly and discard them when the expiration date says to.
Here's another tip for you to keep your drugs safe over time: You know that cotton ball that is packed in every medicine container? You probably keep that cotton in the container.
Wrong! When you get the medicine bottle home and open it, throw that cotton away. The cotton is inserted to protect the pills from rattling around while you're taking them home. But the cotton can become a perfect medium for the development of fungi or other contaminants.
That's right. If you store the medicine in your bathroom -- and I know you'll still do that even after reading this article -- the cotton can become moist and, over a period of time, become contaminated with a fungus or something else that grows in moisture. Cotton, begone!
I hope that you check the location of all your drugs and do two things: look at the expiration dates and throw away old drugs, and then store the good ones in a cool dry place, so they'll be safe and work when you need them.