Drug Expiration Dates: They're Not Just Suggestions
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.