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Drug expiration dates

Post-Dated Checks

I was helping my sister prepare for a move last weekend, and while packing up we were also tossing out some old items. She was going through containers of over-the-counter
medications when she laughed and showed me an aspirin bottle that was almost two years past the “best if used before” date.

But then I stopped to think about the word “best” in that
phrase, and I wondered: How bad could it be to use those
aspirins long after that date? If they weren’t “best,” does
that mean they’d be ineffective? And could they do any harm?

After digging though a little research, I found some
reliable information that runs contrary to the standard
thinking that we should discard a medication after its
expiration date has been reached. But not all drugs are
useable after that date, and the ones that are require
proper storage.

Hot & humid

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.

Pushing the envelope

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 day-one 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 money.)

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.

So in theory, my sister’s aspirin is 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.

On the supplement side

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

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