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Drug Expiration Dates: They're Not Just Suggestions

April 21, 2000 (Washington) -- You really do need to take expiration dateson drugs seriously. Why? Because drugs can become unsafe or lose potency overtime, and the expiration date is as long as the drug company wants to claim itsdrug will be safe and have the correct potency.

I was at the FDA when the rule was issued requiring drug companies to testtheir products to see how long they remained potent and safe, and then toinclude an expiration date on the product. Until the rule was issued, consumershad no idea when how long they could keep their drugs safely.

At the FDA, we recognized that there clearly was a need for consumers tohave some time frames for discarding drugs. All of us -- me included -- havedrugs 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 arestable for as long a period as the company wants to claim the expiration dateis. So if a drug is made in May 2000 and the company has conducted testing thatthe drug will remain safe and potent for two years, the expiration date is May2002. 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 drugwill remain potent for only two years. It means only that the drug hasbeen tested to assure its safety and potency for at least two years. Infact, a drug may be potent for 10 years or more but still have an expirationdate that is only two or three years.

The U.S. military has found that many drugs stored in their facilitieslasted much longer than their expiration dates. The reason is that their drugswere stored under ideal conditions. Not many of us truly can keep our drugsstored in a cool, dry place without being moved for years on end.

The experience with the U.S. military's drugs underscores why you shouldtake expiration dates seriously: You don't store your drugs under idealcircumstances, as the military does.

You probably store some drugs in your bathroom, where they get moist whenyou take a shower or bath. Or you may store some drugs in your kitchen, wherethe stove gets hot, or on the windowsill, where the sun hits them.

Under these circumstances, it is not likely that drugs stored will becomeoutright unsafe, but they could easily lose potency, which means they won't beas effective as they should be.

Health is too important to chance. You want your drugs to work as theyshould. That's why it's so important to store drugs properly and discard themwhen the expiration date says to.

Here's another tip for you to keep your drugs safe over time: You know thatcotton ball that is packed in every medicine container? You probably keep thatcotton in the container.

Wrong! When you get the medicine bottle home and open it, throw that cottonaway. The cotton is inserted to protect the pills from rattling around whileyou're taking them home. But the cotton can become a perfect medium for thedevelopment of fungi or other contaminants.

That's right. If you store the medicine in your bathroom -- and I knowyou'll still do that even after reading this article -- the cotton can becomemoist and, over a period of time, become contaminated with a fungus orsomething else that grows in moisture. Cotton, begone!

I hope that you check the location of all your drugs and do two things: lookat the expiration dates and throw away old drugs, and then store the good onesin a cool dry place, so they'll be safe and work when you need them.