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Drug Expiration Dates: They're Not Just Suggestions

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WebMD Health News

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.

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