I have tons of old medications from prescriptions that I never finished, or giant Costco bottles of Advil etc. A doctor that I know told me that the expiration dates mean nothing and that they are just Big Pharma’s way to insert some planned obsolescence into their products.
Is this true? If not, what actually happens to the medications after their expiration dates?
In: Chemistry
This only means they have not done testing past this timeframe. Stability teams test different variables such as light and temp change on the compounds, and then they test these in incremental times. They are not tested past a certain point and therefore that is the cutoff date of GUARANTEE, or Conformance. Also past this time the compounds degrade and might have a lower efficacy than when “fresh”
I work in QC
I asked this same question to my cousin who’s a pharmacologist. Her answer was essentially it truly means very little for the vast majority of medications. They do slowly degrade after a while as the active ingredients break down over time. However most medications don’t go bad like food and won’t harm you if you take them post expiration. They just won’t be as effective. THAT is why the expiration date is there. It’s the drug company saying “we no longer guarantee the effectiveness of this drug after this date.”
Once they’ve passed the date, the manufacturer no longer guarantees they’ll work as advertised.
Now obviously they’re not fine on March 31st and totally useless on April 1st, but they do chemically degrade over time and may eventually transform into some useless powder or sludge or a mystery chemical.
The exact process of chemical breakdown, how long it takes, and how hazardous or inert the resulting products will be varies considerably between medications. Some are small molecules theoretically stable for decades, others are complicated structures that break down rapidly.
Overtime, various chemical effects will change the chemicals in medications into other chemicals, which may have various effects: changing flavor, making the medication ineffective, making the medication stronger, or even making the medication toxic.
There are a number of causes of these, a few of the most common are:
– Oxygen in the air doesn’t like to remain free oxygen, and may combine with other chemicals. As a side note, this is why fat goes rancid.
– UV light, especially from the sun, tends to cause chemicals to break apart.
– Heat will cause chemicals to break apart or combine in a large number of ways.
– Cold will cause chemicals to change form, such as freezing, which can cause various damage.
– Moisture in the air will tend to absorb into chemicals, changing their behavior.
– Microbes might start to grow in or on the medication, which is more likely for wet medicines.
The expiration date is the time window the manufacturer is willing to guarantee these effects remain minimal. The FDA requires companies provide *some* timeline for safety reasons.
That said, the US government also keeps a [drug stockpile](https://aspr.hhs.gov/SNS/Pages/Sustaining-the-Stockpile.aspx), and regularly tests medications in it for safety and effectiveness. It is very common for drugs to remain good for years after their official expiration date, and some even for decades.
Naturally, that stockpile is kept under ideal conditions, and typical home storage may not get the same results. When the stockpile shows medications remain good much longer than their expiration date, the FDA will also do additional review to see if that holds under more normal storage, and may tell manufacturers to increase the expiration period.
Companies are required to perform stability testing as part of the registration process and on an ongoing basis for their production runs. From their point of view it just doesn’t make sense to test things for long periods of time as there’s no financial incentive to do so. So, in effect, when they put a shelf life on a drug they’re saying that that’s as far as we’ve tested it’s stability so there’s no guarantee beyond that time point. It’s important to note that the shelf life also assumes certain storage conditions. i.e. a sealed container sitting at or near room temperature. Stuff stored open or in humid/hot conditions or stored in sunlight may not have the same shelf life.
As for what happens to drugs to cause degradation it can be any number of things. It may chemically break down into smaller molecules via oxidation, hydrolysis, UV light exposure, etc… or it can combine with excipients (the non active ingredient portion of the medicine) to form a new molecule. Either route can create substances which are more potent, less potent, or even non-active for it’s intended purpose. Companies are also required to evaluate these break down products within the shelf life period to make sure that nothing unsafe is generated. Some drugs may also be perfectly stable under reasonable storage conditions and be good for their intended purpose indefinitely. It all depends on the drug chemistry, what excipients are used and how it’s stored.
I’ve been in the business for years and can answer this from a supply chain perspective.
Most manufacturers have a program that allows pharmacies to “trade-in” the expired drugs in exchange for credit to buy newer drugs.
The pharmacies pack and ship their drugs to a reverse logistics provider ( almost always Inmar or PharmaLogistics). Inmar will count/verify the drugs and send it to a separate company for destruction. The DEA wants everyone involved to maintain a proper chain of custody for controlled substances. Each party in the chain returns a DEA 222 form to verify that drugs were properly received.
Inmar/PL also works as the aggregator between manufacturers, wholesalers and pharmacies to determine how much money is owed.
> A doctor that I know told me that the expiration dates mean nothing and that they are just Big Pharma’s way to insert some planned obsolescence into their products.
Your doctor friend should have his medical license revoked for spreading conspiracy bullshit.
> Is this true? If not, what actually happens to the medications after their expiration dates?
No it’s most definitely not. For most medications the answer is that the medication is simply not tested beyond that length of date. Therefore the manufacture can make no claim as to its effectiveness. Generally, especially for over the counter drugs they just become less effective over time, though not necessarily by the end date. However for drugs where precise dosage is important such as insulin or antibiotics lowered potency can be deadly. Finally in rare cases the drug can break down into something toxic. But planned obsolescence? No, not remotely.
It depends on the medication usually it just starts losing some of its effectiveness but nothing too serious, that being said my mom once took some expired pills and got all dizzy and nauseated
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