When you read the label on a medication bottle, you’re likely looking for a few key things, like the dosage or side effects. The expiration date, however, is not quite so intuitive or straightforward. If you’ve wondered if your medications expire, yes, they do. Pharma companies include an expiration date on your prescriptions for a reason, but it’s not like being in danger of drinking spoiled milk or eating bad meat. Read on to find out why your Rx labels put a time limit on your meds.
Who determines drug expiration dates?
In 1979, the Food and Drug Administration began requiring that pharmaceutical companies label all commercial drugs, both prescriptions and over-the-counter medications, with an expiration date. This date is supposed to signal the point at which a drug is no longer potent enough to provide the desired effects. In some cases, it can also signal that the drug is no longer safe to take.
While the FDA mandates the use of expiration dates, it doesn’t oversee how they’re determined. That means pharmaceutical companies are on their own to figure out a drug’s shelf life.
How do these companies determine expiration dates?
Before a company rolls out a drug, it conducts rounds of stability testing. Christie Kunde is a Phoenix-based pharmacist who has worked as a quality control chemist in the pharmaceutical industry. She says during these studies, chemists store drugs in various conditions and put them through tests to determine their safety and potency over time.
The goal is to see how products react to variables like light, temperature and humidity. Companies typically test products for one to five years, which means that most medication expiration dates fall within this timeline.
So what does it mean if a medication’s expired?
Since pharmaceutical companies only spend so much time testing drugs, they actually don’t often get “true” expiration dates right. For instance, if a company stops testing after five years and the drug still has full potency, there’s no official word on whether it would also be good in ten years. The expiration date doesn’t necessarily mean that a drug has gone bad — it’s just the last date at which the manufacturer guarantees the labeled potency and safety.
A 2006 study of 122 drugs tested by the US government showed that two-thirds of expired medications were stable (i.e., hadn’t lost potency) every time a sample of stockpiled medications was tested. This often meant manufacturers could reasonably extend the shelf life of drugs by four years on average. In one 2012 study, researchers tested 14 different active ingredients that had expired between 28 and 40 years prior and found that 12 of them had retained 90 percent of their potency.
Yet hospitals and pharmacies are required by law to throw out expired medication, which means a lot of money ends up in the trash. Various organizations, activists and researchers have called to extend the shelf life on certain products to mitigate waste, but for now, the established protocols remain in place.
What medications become toxic after expiration? And what happens if you take expired medication?
In most cases, Kunde says expired drugs aren’t actually harmful, just less effective.
While solid drugs, such as tablets and capsules, are typically safe and effective past their expiration date, drugs that exist in a solution or are reconstituted as a suspension (meaning you mix a powder with a liquid to create a liquid medication) may lose potency more quickly.
Experts say it’s especially important to look at the expiration dates for these types of prescriptions:
- Refrigerated drugs, like penicillin, amoxicillin and most vaccines, and other liquid antibiotics tend to lose effectiveness more quickly. Some are also subject to potentially harmful bacterial growth after their expiration date.
- Insulin has shown signs of physical decay after its expiration date.
- EpiPen, the injectable medication used to stop severe allergic reactions, loses effectiveness quickly after its expiration date.
- Aspirin’s potency tends to plummet after its expiration date, while drugs like ibuprofen and acetaminophen retain potency for longer periods of time
- Tetracycline, an oral antibiotic, is a controversial drug. “Tetracycline breakdown products have been linked to reversible kidney injury in reports going back decades,” says Kunde.
- Medicated eye drops can carry a risk of bacterial contamination once they’ve been opened.
What should you do with expired drugs?
If you come across a bottle with an expiration date in the past, check with your provider. You don’t automatically need to toss it — just take certain precautions to protect your health while avoiding unnecessary waste.
In general, always make sure you’re storing your medications properly. “Proper storage of medications can help them last longer,” says Kunde. “Because of the heat and humidity, the bathroom cabinet is not a good place to keep medicine. In the same way, you shouldn’t leave medicine in a hot car. They stay most stable in places that are dry, cool and dark, with the cap on.”
If you’re uncertain about any expired prescriptions or OTC medications, check with your provider. A doctor or pharmacist might tell you to look for visual signs of expiration. While capsules and tablets will likely look the same regardless of whether they’ve lost potency, drugs that exist in a solution, especially injectable drugs, might start to look cloudy or discolored. If so, into the garbage they go.
Lastly, consider what you’re taking the medicine for. Are you popping an allergy pill to stop the sniffles or an EpiPen to stop anaphylactic shock?
“I’ve used ibuprofen and acetaminophen after their expiration dates,” says Kunde. “A lack of pain relief is the only major negative effect if it loses too much potency and does not work.”
But when the stakes are higher, the repercussions could be much greater. “If the medicine could save your life or prevent serious illness,” says Kunde, “it’s best not to use it after the expiration date.”