Many Medicines Are Potent
Years Past Expiration Dates
By LAURIE P.
COHEN Staff Reporter of THE WALL STREET JOURNAL
really stop working after the date stamped on the bottle?
Fifteen years ago, the
U. S. military decided to find out. Sitting on a $1 billion
stockpile of drugs and facing the daunting process of destroying
and replacing its supply every two to three years, the military
began a testing program to see if it could extend the life of
The testing, conducted by the U. S. Food and Drug
Administration, ultimately covered more than 100 drugs,
prescription and over-the-counter. The results, never before
reported, show that about 90% of them were safe and effective
far past their original expiration date, at least one for 15
years past it.
In light of these results, a former director of the testing
program, Francis Flaherty, says he has concluded that expiration
dates put on by manufacturers typically have no bearing on
whether a drug is usable for longer.
Mr. Flaherty notes that a drug maker is required to prove only
that a drug is still good on whatever expiration date the
company chooses to set. The expiration date doesn't mean, or
even suggest, that the drug will stop being effective after
that, nor that it will become harmful.
"Manufacturers put expiration dates on for marketing,
rather than scientific, reasons," says Mr. Flaherty, a
pharmacist at the FDA until his retirement last year.
"It's not profitable for them to have products on a
shelf for 10 years. They want turnover."
- Dr. Francis
US FDA expiration testing program
"Manufacturers put expiration dates on for marketing, rather
than scientific, reasons," says Mr. Flaherty, a pharmacist at
the FDA until his retirement last year. "It's not profitable for
them to have products on a shelf for 10 years. They want
The FDA cautions that there isn't enough evidence from the
program, which is weighted toward drugs needed during combat and
which tests only individual manufacturing batches, to conclude
that most drugs in people's medicine cabinets are potent beyond
the expiration date. Still, Joel Davis, a former FDA
expiration-date compliance chief, says that with a handful of
exceptions -- notably nitroglycerin, insulin and some liquid
antibiotics -- most drugs are probably as durable as those the
agency has tested for the military. "Most drugs degrade very
slowly," he says. "In all likelihood, you can take a product you
have at home and keep it for many years, especially if it's in
Drug-industry officials don't dispute the results of the FDA's
testing, within what is called the Shelf Life Extension Program.
And they acknowledge that expiration dates have a commercial
dimension. But they say relatively short shelf lives make sense
from a public-safety standpoint, as well.
New, more-beneficial drugs can be brought on the market more
easily if the old ones are discarded within a couple of years,
they say. Label redesigns work better when consumers don't have
earlier versions on hand to create confusion. From the
companies' perspective, any liability or safety risk is
diminished by limiting the period during which a consumer might
misuse or improperly store a drug.
"Two to three years is a very comfortable point of commercial
convenience," says Mark van Arandonk, senior director for
pharmaceutical development at Pharmacia & Upjohn Inc. "It gives
us enough time to put the inventory in warehouses, ship it and
ensure it will stay on shelves long enough to get used." But
companies uniformly deny any effort to spur sales through
Why Not Longer?
Now that the FDA has found that many drugs are still good long
after they have supposedly expired, why doesn't it advocate
later expiration dates for consumer drugs? One reason is that
the consumer market lacks the military's logistical reasons to
keep drugs around longer.
Frank Holcombe, associate director of the FDA's office of
generic drugs, says that in many cases a manufacturer could
extend expiration periods again and again, but to support those
extensions, it would have to keep doing stability studies, and
keep more in storage than it would like.
Mr. Davis adds: "It's not the job of the FDA to be concerned
about a consumer's economic interest." It would be up to
Congress to impose changes, he says.
As things stand now, expiration dates get a lot of emphasis. For
instance, there is a campaign, co-sponsored by some drug
retailers, that urges people to discard pills when they reach
the date on the label.
And that date often is even earlier than the one the maker set.
That's because when pharmacists dispense a drug in any container
other than what it came to them in, they routinely cut the
expiration date to just one year after dispensing. Some states
even require pharmacists to do this.
Meanwhile, poor countries -- under urging from the World Health
Organization -- often reject drug-company donations of
much-needed medicines if they are within a year of their
It isn't known how much of the $120 billion-plus spent annually
in the U. S. on prescription and over-the-counter medicines goes
to replace expired ones. But in a poll done for The Wall Street
Journal by NPD Group Inc. of Port Washington, N. Y., 70% of
1,000 respondents said they probably wouldn't take a
prescription drug after its expiration date; 72% said the same
of an over-the-counter remedy.
"People think that, upon expiration, drugs suddenly turn toxic
or lose all their potency," says Philip Alper, professor of
medicine at University of California at San Francisco. In his
own practice, Dr. Alper says, "I frequently hear -- from
patients who can't afford medicine -- that they have thrown away
expired drugs." He says companies should be required to test
drugs for longer periods and set later expiration dates when
Some manufacturers first began putting expiration dates on drugs
in the 1960s, although they didn't have to. When the FDA began
requiring such dating in 1979, the main effect was to set
uniform testing and reporting guidelines. As now required by the
FDA, so-called stability testing analyzes the capacity of a drug
to maintain its identity, strength, quality and purity for
whatever period the manufacturer picks. If the company picks a
two-year expiration date, it needn't test beyond that.
Testing for a two-year expiration doesn't initially entail
holding a drug for two years. Rather, the drug is tested by
subjecting it to extreme heat and humidity for several months,
then chemically analyzing each ingredient's identity and
strength. (After the date is set and the drug is marketed,
testing continues for the full two years.)
The FDA also uses chemical analysis in testing for possible
shelf-life extension; it doesn't test on human subjects. Testing
conditions are such that any medicine that meets, say, the
standards for a two-year expiration date probably lasts longer,
the FDA and drug companies agree.
Consider aspirin. Bayer AG puts two-year or three-year dates on
aspirin and says that it should be discarded after that. Chris
Allen, a vice president at the Bayer unit that makes aspirin,
says the dating is "pretty conservative"; when Bayer has tested
four-year-old aspirin, it remained 100% effective, he says.
So why doesn't Bayer set a four-year expiration date? Because
the company often changes packaging, and it undertakes
"continuous improvement programs," Mr. Allen says. Each change
triggers a need for more expiration-date testing, he says, and
testing each time for a four-year life would be impractical.
Bayer has never tested aspirin beyond four years, Mr. Allen
says. But Jens Carstensen has. Dr. Carstensen, professor
emeritus at the University of Wisconsin's pharmacy school, who
wrote what is considered the main text on drug stability, says,
"I did a study of different aspirins, and after five years,
Bayer was still excellent. Aspirin, if made correctly, is very
Only one report known to the medical community linked an old
drug to human toxicity. A 1963 Journal of the American Medical
Association article said degraded tetracycline caused kidney
damage. Even this study, though, has been challenged by other
scientists. Mr. Flaherty says the Shelf Life program encountered
no toxicity with tetracycline and typically found batches
effective for more than two years beyond their expiration dates.
Plea From the Air Force
The program dates to a U. S. effort begun in 1981 to increase
military readiness by buying large quantities of drugs and
medical devices for the armed forces. Four years later, more
than $1 billion of supplies had been stockpiled. The General
Accounting Office audited Air Force troop hospitals in Europe
and found many supplies at or near expiration. It warned that by
the 1990s, more than $100 million would have to be spent yearly
The Air Force Surgeon General's office asked the FDA if it could
possibly extend the shelf life of these drugs. The FDA had the
equipment for stability testing. And because it had approved the
drugs' sale in the first place, it also had manufacturers' data
on the testing protocols.
tells you in pharmacy school that shelf life is about
marketing, turnover and profits."
pharmacist, and direct of the U.S. Army's pharmaceutical
Testing for the Air Force began in late 1985. In the first year,
58 medicines from 137 different manufacturing lots were shipped
to the FDA from overseas storage, among them penicillin,
lidocaine and Lactated Ringers, an intravenous solution for
dehydration. After testing, the FDA extended more than 80% of
the expired lots, by an average of 33 months.
In 1992, according to the FDA, more than half of the expired
drugs that had been retested in 1985 were still fine. Even now,
at least one still is.
came as a revelation for Army Col. George Crawford when he
took over military oversight of the program in 1997. He is a
pharmacist, but "nobody tells you in pharmacy school that shelf
life is about marketing, turnover and profits," he says. (The
drug makers don't agree that it is, however.)
How It Works
The military's base for the program is a dingy barracks room in
Fort Detrick, Md. There, a group headed by Air Force Lt. Col.
Greg Russie, who recently took over from Col. Crawford, tracks
drugs that are near expiration at defense facilities all over
the world, selecting many for retesting. They are shipped to the
FDA, which sends them to its laboratories.
The FDA's lab in Philadelphia recently tested five automatic
injectors containing an antidote to chemical poisoning, which
were purposely held for three months in conditions even hotter
and more humid than the FDA requires in consumer testing of
drugs. The FDA tested the drug contained in the injectors,
pralidoxime chloride, by separating its ingredients and
measuring the strength and quality of each, then applying a
computer model to determine whether a shelf-life extension was
The injectors' original expiration date was November 1985. The
FDA had retested them periodically ever since, each time
approving their continued use. The batch, made by Ayerst
Laboratories, now part of American Home Products Corp.'s
Wyeth-Ayerst unit, is 18 years old. It is 15 years beyond the
expiration date applied by Ayerst. The FDA found it is still
A spokesman for Wyeth-Ayerst says it "uses scientific data to
establish expiration dates" and "tries to have the longest
possible dating on products that scientific data supports." The
company is aware of the FDA retesting program. It says it can't
comment specifically on the injectors tested by the FDA.
officials say that during the program's 15 years, drug
makers have never objected to any of its procedures or
findings. 'They may not have liked what we were doing,
but they weren't able to challenge it," [says Dr.
Francis Flaherty, Director, US FDA expiration testing
A Few Fail
Shelf-life extensions are "intentionally conservative," the
FDA's Mr. Flaherty told military brass in a 1992 speech. He says
that if the agency extended an expiration date by 36 months, it
had concluded the lot would retain all of its safety and
efficacy for at least 72 months.
A very few drugs aren't retested. The military has found that
water-purification tablets and mefloquine hydrochloride, for
malaria, routinely fail stability testing beyond their
expiration dates, so it has removed them from the program.
Also excluded are large-volume intravenous solutions, such as
saline. "We don't like to test those," says Col. Crawford. "Not
because we can't, but because it would be politically sensitive
if G. I. Joe was lying in bed and saw it had originally expired
three years ago."
Mr. Flaherty has said that while he tested a handful of drug
batches that didn't even make it to their expiration dates, most
drugs were "surprisingly durable." In one instance, he says,
drugs labeled for room-temperature storage had been kept for two
years in a warehouse in Oman that averaged 135 degrees
Fahrenheit in the daytime. Upon expiration, the drugs, which
included the local anesthetic lidocaine and atropine, a
nerve-gas antidote also used by eye doctors to dilate pupils,
"were well within the standards for potency and other quality
characteristics," he says.
One medicine the FDA has endorsed for extensions is
ciprofloxacin hydrochloride tablets, an antibiotic marketed by
Bayer as Cipro. One batch had an expiration date of March 1989.
More than 9 1/2 years later, the FDA found the tablets still
good; it then extended some of them for 18 more months and
others for 24 more months.
Albert Poirier, quality-assurance director for Bayer's
pharmaceutical division, says he isn't surprised because Cipro
"is a stable drug molecule" in tablet form. "We go for a shelf
life that will be safest for patients," he says. "We want the
drug to be used up within three years. We wouldn't want a
patient to have it for 10 years because they'd have an old
package insert" that might omit new information or
contra-indications and because "we'd have no control over how
they'd store the drug during this time."
Another extended drug is Thorazine, a tranquilizer chemically
known as chlorpromazine tablets. Batches bearing December 1996
expiration dates -- unused and unopened, as is the case with all
drugs evaluated in the Shelf Life program -- were tested in July
1998 and extended for two years. A spokesman for the maker,
SmithKline Beecham PLC, says it applies an expiration date 24
months after manufacture. "We think that is the appropriate
expiration date," he says. "We don't benefit from short
Some other drugs the FDA has extended at least two years beyond
their expiration dates are diazepam, sold as Valium; cimetidine,
sold as Tagamet; phenytoin, sold as Dilantin; and the
antibiotics tetracycline and penicillin.
On a cost-benefit basis, the program's returns have been huge.
The first year, the Air Force paid the FDA $78,000 for testing
and saved 59 times that sum by not needing to replace the drugs.
After other services joined, the military from 1993 through 1998
spent about $3.9 million on testing and saved $263.4 million on
drug expense, according to Lt. Col. Russie.
Says Mr. Flaherty: "We've cost the pharmaceutical companies
hundreds of millions of dollars in sales of new stuff to the
Department of Defense."
More than 12 years ago, Messrs. Flaherty and Davis explained the
program to drug-company chemists at a meeting of the American
Association of Pharmaceutical Scientists in Woodbridge, N. J.,
going into detail about how the FDA decided whether to extend a
given expiration date. Mr. Davis concluded by noting how much
the U. S. had saved by extending shelf lives instead of
"destroying large quantities of still-useful medical products...
Mr. Flaherty says the FDA was keenly aware that if its
methodology was flawed, or its results incorrect even once, its
credibility would be attacked. Yet FDA officials say that during
the program's 15 years, drug makers have never objected to any
of its procedures or findings. "They may not have liked what we
were doing, but they weren't able to challenge it," he says.
The Message to Civilians
While the military is finding it can keep most drugs longer,
civilians hear quite a different message. For instance, a
campaign called the National Expired and Unused Medication Drive
has collected and destroyed 36 tons of drugs since 1991, says
its founder, Kathilee Champlin. Ms. Champlin, of Colorado
Springs, Colo., says her interest derives from experience
working with the elderly and seeing how hard it was for them to
keep track of all their medications. She says she wasn't aware
of any FDA program to extend drugs' shelf lives.
Her group has gained sponsorship from the some big drug
retailers, including Wal-Mart Stores Inc. It sponsors the
campaign to be "a good corporate citizen," says Frank Seagrave,
vice president of pharmacy merchandising. "We believe that
people should dispose of unused prescription medicines a year
after they get them," he says, adding that Wal-Mart sometimes
gives people a free bottle of vitamins if they bring in expired
Johnson & Johnson's Janssen Pharmaceutica unit, a drug maker,
also sponsors Ms. Champlin's campaign. "We think it's important
to educate the public about the risk of taking drugs that are
expired and to raise public awareness," says a spokesman for
Janssen. Both Wal-Mart and J&J say that supporting the campaign
to discard expired drugs has nothing to do with their sales
Many pharmacists also play a role in shelf lives. The U. S.
Pharmacopeia, a not-for-profit scientific group that develops
standards for the drug industry, urged in 1985 that pharmacists
set expiration dates at no more than one year if they were
dispensing drugs in a bottle other than the manufacturer's
original packaging. "New containers may let in more moisture and
heat than the container the manufacturer used for the stability
study," accelerating the drug's degradation, says the USP
General Counsel Joseph Valentino.
The recommendation became a USP requirement in 1997. As a
result, "the majority of pharmacists shorten the manufacturers'
expiration dates" on prescription drugs to one year or less,
says Susan Winckler, an official of the American Pharmaceutical
Association. In fact, in 17 states, pharmacists now are legally
required to do so. Ms. Winckler says shortening the dates makes
sense because many people store drugs in moist bathrooms. She
says the one-year rule is "motivated by product integrity and
not by profit."
Even the FDA has sometimes pushed for throwing out drugs at
their expiration date. Last October it co-sponsored, with the
National Association of Chain Drugstores and others, a campaign
that urged women not to use medications beyond the expiration
dates because, as the brochure put it, "they may not work." Mr.
Davis says this shows just how obscure the military Shelf Life
Extension Program is. "Many people at the FDA have absolutely no
idea this program exists," he says.