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Drug expiration dates

Dates To Remember

Whenever you hear FDA officials warn against purchasing inexpensive drugs from Canada or other foreign countries, one of the primary dangers they cite is the possibility that the expiration dates for the drugs may have passed.

In the case of most drugs, however, this is just another hollow warning. As FDA officials are fully aware.

Extreme measures

In 1979 the FDA set out guidelines for expiration dates, required of all prescription and over-the-counter drugs. But the regulatory mandate to drug companies was not to establish exactly how long a drug would be potent and safe, but rather to set an arbitrary date, and then do the testing necessary to guarantee that a drug would be potent and safe at least until that date.

So when a company sets an expiration date for a new drug – let’s say, for instance, 18 months – they don’t place the drug on a shelf for a year and a half and then test it for potency. Instead they subject it to extremes of humidity, heat, and light (the three enemies of drug potency), designed to approximate deterioration over time. This is followed by chemical analysis to insure that the active ingredients are still intact.

Since the beginning of the expiration date requirement, scientists for both the FDA and drug companies have generally agreed that the testing standards are rigorous enough that most drugs are safe and potent well beyond their established expiration dates. And while this information wasn’t really kept secret, no one was shouting it from the rooftops either.

Then in the mid-80s, a major drug customer started asking questions.

Military savings

It’s probably safe to say that the number one consumer of prescription drugs in the U.S. is the military. And because our armed forces have a huge stockpile of drugs on hand at all times, expiration dates are an important and expensive issue. Imagine: If every drug purchased by the military were tossed out on the first day after its expiration month, millions of dollars would be going down the drain yearly.

In 1985 the military had reached a point where its store of drugs was worth about $1 billion. FDA scientists were called on to help determine which drugs could be safely used beyond listed expiration dates. The FDA tests showed that out of more than 100 tested drugs, about 90 percent of them were still fully potent and safe well past their expiration date, and in some cases for YEARS past that date.

As a result, over a period of five years in the mid-90s, the military spent almost $4 million to test certain drugs for realistic expiration dates, and ended up saving more than $260 million by extending the use of many drugs past their listed dates. (Go ahead and savor that. It’s not every day you hear about the military SAVING our tax dollars.)

Ancient aspirin

Not all drugs are quite as durable as the majority of them are. A former FDA expiration-date compliance chief named Joel Davis told the Wall Street Journal that nitroglycerin, insulin, and some liquid antibiotics are more perishable and should be used or discarded before their listed “use by” date.

But more common drugs like aspirin, for instance, are probably still good a full two years past the expiration date. In fact, Bayer has tested aspirin as old as four years and found it to be just as effective as the day it was manufactured. The big question, however, is this: What happens to that aspirin and other drugs in your medicine cabinet over the course of several years?

As I said above, the culprits that rob drug potency are heat, humidity, and direct light. So ironically, medicine cabinets in bathrooms that get steamed up by daily hot showers may not be the best place to keep medications. But a refrigerator is perfect: cool, dark, and dry.

Dated supplements

Does all of the above also apply to vitamins and other dietary supplements?

In many respects, yes.

Of course the military doesn’t stockpile $1 billion worth of vitamins, so there’s been no high-profile testing to use as a guide. But all reliable supplement manufacturers conduct tests to determine how long the full potency of their products can be guaranteed. And while supplements are generally regarded as effective and safe beyond their expiration dates, you wouldn’t purchase food that had passed the “sell by” date, and I’m sure you wouldn’t purchase a supplement after that date either.

Like drugs, vitamins and supplements should be kept away from heat, humidity, and direct light. And if you should notice a change in the odor, taste or appearance of a supplement (or a drug), you would be wise to discard it, regardless of the expiration date.

Bottom line: Store your supplements and medications properly, and many of them could still be effective long after the “use before” date.

To Your Good Health,

Jenny Thompson
Health Sciences Institute

Sources:

“Many Medicines Prove Potent for Years Past Their Expiration Dates” Laurie P. Cohen, the Wall Street Journal, 3/28/00, wsj.com
“Vitamins Expiration Date” Elizabeth Somer, M.A., R.D., WebMD, 11/20/00, content.health.msn.com
“Risk Factors for Advanced Colonic Neoplasia and Hyperplastic Polyps in Asymtomatic Individuals” Journal of the American Medical Association, vol. 290, no. 22, 12/10/03, ncbi.nlm.nih.gov



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