New Evidence on Expiration Dates
October 12, 2012 
37 Comments
Over the years, I have expressed my opinions on the bogus nature of the expiration dates stamped on medications in pill or capsule form. I have cited the findings of the Shelf Life Extension Program, a program meant to investigate the possible usefulness of the millions of doses of various expired medications stockpiled by FEMA for use in peacetime disasters.
In my original article, “The Truth About Expiration Dates” 2 years ago, I indicated these findings were no longer available to the public. Now, a breakthrough scientific article has been published in the respected journal “The Archives of Internal Medicine”. Below is the article in its entirety, with important sections in bold type:
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October 8, 2012 — An analysis of 8 medications indicates that most of the active ingredients they contain were present in adequate amounts decades after the drugs’ expiration dates, according to results from a study published online October 8 in the Archives of Internal Medicine.
Lee Cantrell, PharmD, from the California Poison Control System, San Diego Division, University of California San Francisco School of Pharmacy, and colleagues used liquid chromatography/mass spectrometry to measure the amounts of the active ingredients in the medications. The medicines, which had expired 28 to 40 years ago, were found in a retail pharmacy in their original, unopened packaging.
To meet US Food and Drug Administration (FDA) standards, an active ingredient must be present in 90% to 110% of the amount indicated on the label. Drug expiration dates are set for 12 to 60 months after production, even though many compounds can persist far longer.
In the new analysis, 12 of the 14 active ingredients persisted in concentrations that were 90% or greater of the amount indicated on the label. These 12 compounds retained their full potency for 336 months (Dr. Bones 28 years) or longer. Eight of them retained potency for at least 480 months (dr. bones: 40 years). Dr. Cantrell’s team was unable to find a standard for homatropine, 1 of the 15 ingredients.
Only aspirin and amphetamine fell below the 90% cutoff. Phenacetin was present at greater than the cutoff in Fiorinal (butalbital, aspirin, caffeine, and codeine phosphate, but was considerably less in Codempiral No. 3. The authors attribute the deficit in Codempiral to conditions that led to preferential degradation of phenacetin because of its amide group, compared with codeine, which is also in Codempiral but is more chemically stable.
Three compounds persisted in greater than 110% of the labeled contents: methaqualone (in Somnafac), meprobamate (in Bamadex), and pentobarbital (in Nebralin). These relatively high amounts may reflect degradation of other components of the compounded drug, the fact that the samples were produced before FDA-instituted quality control measures in 1963, or inconsistencies of the analytical techniques between when the drugs were compounded and now. The new findings are consistent with the efforts of the Shelf-Life Extension Program, which has extended the expiration dates on 88% of 122 drugs tested so far. Extensions range from 66 to 278 months.
“Our results support the effectiveness of broadly extending expiration dates for many drugs,” the researchers conclude. They also point out that extending shelf life can significantly lower costs to consumers.
Limitations of the analysis, the investigators write, include an inability to confirm the storage conditions of the drug samples, as well as imprecise dating of the samples. The authors have disclosed no relevant financial relationships.
http://archinte.jamanetwork.com/article.aspx?articleid=1377417
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For the preparedness community, this information is very important, as it lends credence to what I have been telling you all along: Get your medical supplies together, and don’t throw out drugs in pill or capsule form just because they have passed their expiration dates. We are anxiously awaiting lists of the 122 drugs that the Shelf Life Extension Program has tested, but you can expect them to be medications that will be useful in the aftermath of a catastrophe.
Dr. Bones
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Thank you for this additional confirmation on pharmaceutical shelf lives, Dr. Bones – along with the list of antibiotics you recommended in an earlier article. Do you believe or have you read that this is also true of the more common intravenous solutions (e.g. saline, ringers, etc.)? I see that most manufacturers only show a 2-year shelf life for these.
I believe that normal saline, which contains no organic molecules will last quite a long time, but ringer’s lactate, D5W. and anything with carbohydrates will degrade relatively quickly after expiration. This is true of most medications in liquid form, as well…
There was a Pentagon study at least a decade ago that confirmed that the military didn’t need to spend a billion dollars to replace it’s drug supply. It ran in the WSJ and I corresponded with the author on it since my daughter was doing a science project on drug expirations. So much money wasted on so called “expired” medications. What a waste.
you said it, brother!
Hi Dr. Bones – What about Albuterol inhalers? My daughter has asthma & I like to have plenty on hand. Any ideas on the shelf-life of these? Does used versus unused status change the shelf-life? Thanks!
I know about liquids and solid medication, but albuterol is in the form of a gas, so I will have to research it and get back to you…
I have plenty of albuterol inhalers in storage. The one I am currently using is 9 years old and seems to be just a tad bit less effective. I am storing them in a air/waterproof container in my basement. I live in a northern climate. so the basement really never gets over 60 degrees even when the furnace runs. I have been a nurse for 30 years so know what to look for in effectiveness. Oh.. the brand is “Ventolin” which I bought without a prescription through Inhousepharmacy,biz
Hi Dr. Bones,
I have a bottle of liquid Penicillin. I keep it in my refrigerator and it says it expired 11/2011. Can you tell me if this is still safe to use? Just 2 days ago I ordered another bottle but haven’t discarded the old one yet. If this is still useable it would be fantastic!
Thank you
medications in liquid form don’t last very long after their expiration date. While it may not be dangerous, it is likely to have lost much of it potency.
The sad thing about this is that the “thrown-away” drugs and those expelled from the bodies of humans and animals retain potency far longer than we were led to believe. This means they can and do create toxic environments in our fertilizers, drinking water and other contaminated consumables. Another coincidence of the toxic attack on the people?
Thank you. This is valuable information.
My pulmonologist told me that inhalers were good long after the expiration dates as long as the propellant was still in the canister to propell it out. . I’d heard years ago that expired meds were shipped to Africa to be used there. Thanks! Ins plans limit how often one can fill a prescription. Usually one can get renewal up to a few days or week ahead, so started getting ahead by keeping track several years ago. If computers go down and trucks don’t run, what are many to do with out their life dependent meds,?
Some expired meds can become stronger with age. I learned this when I took Atarax that was expired over a year. It seemed to be about triple strength. I was bouncing off walls. Use caution with expired meds. We expect them to weaken with age, but that is not always true.
In the study, 3 of the 15 medication analyzed were at 110% potency, which makes your case!
This does occur occasionally, due to the degradation of other ingredients used in compounding the drug…
“Only aspirin and amphetamine fell below the 90% cutoff.” So how long do you think that these drugs will last if they are unopened?
remember that the criteria were tough, those two medications could have been at 80% potency and they would have failed. I believe they will still have some effect.
I have put samples of thyroid meds/blood pressure meds/ in mason jars and sealed them from the air. Hope it works or I’m in trouble.
I think that’s a sound strategy, Sarah…
Extending the “official” shelf life of drugs would also help another issue: namely that of medical waste annually flushed down American toilets that is polluting our water table AND our DRINKING WATER! By recycling the drugs least affected by time or extending the legal use by date, we could effectively control the drinking water pollution problem!
It’s true that many ‘expired’ drugs maintain potency after their expiration date and can still be used safely. However, you should NEVER TAKE EXPIRED TETRACYCLINE antibiotics (which include DOXYCYCLINE & MINOCYCLINE). Taking these can cause Fanconi Syndrome which can lead to KIDNEY DAMAGE. Learned about this in Pharmacy school over 20 years ago! Be safe and discard expired tetracycline antibiotics.
My son takes Oxybutin on a daily basis. We only get enough for one month at a time. How can we get extra to store, or will my son be left ‘out of luck’ when the ‘fan hits the ceiling’? He is Spina bifidia and gets it for his kidney and bladder function. He is 19.
This is a dilemma for many whose medications have few natural or veterinary equivalents. An honest discussion with his physician is in order here, and perhaps you should hand him my “open letter to doctors about preparedness” article. Use the search engine on the upper right of the website to find it.
all the best…
I guess my daughter that has Type I Diabetes will probably end up dying because of lack of insulin, which is her life saver right now. She only gets a one month at a time supply also. Without her pump she would go into a seizure, either she would be limp as a rag doll or stiff as a board. This was one scarry situation until we got the pump.
1) Some were assayed as having 110% of the amount on the label. If GMP monitoring allows 110% of amount on label to actually be there, does it allow 90%?
2) If any amount of the drug (I’ll call it “target chemical”, since we could also talk about expiration dates on nutrition supplements) was found after the expiration date that is less than was originally there, what happened to that amount less, what did it turn into? Did it turn into something dangerous? E.g. some nutrients convert into forms that are antagonistic in some way, e.g. an antioxidant turning into a pro-oxidant or a nutrient turning into a chemical that competitively inhibits the original nutrient (B12 and unsaturated fats are examples of that). Might a drug chemical in expiring turn into a (worse) toxin? Considering “first, do no harm”, I’m not satisfied that some monetarily useful amount of the original target chemical is there without knowing what has appeared over time to take its place. How about the non-target chemicals, the binders and such, do they turn into something bad way past the expiration date?
My mate is allergic to certain bees and wasps and keeps an Epipen on hand. They have a very short expiration time. Are they likely to be viable past the expiration date? If not, what’s the best treatment for allergic reactions when epinephrine isn’t available?
What about epinephrine? My spouse keeps epipen on hand because he is allergic to bee stings. The expiration time is always very short on these. I assume because it’s liquid, that it’s not good past the exp. date. What alternatives are there for people with severe allergies, if epinephrine isn’t available?
epinephrine, as it comes in liquid form, will lose potency over time but doesn’t become dangerous. You might just have to give more than 1 injection.
Dr. Bones