Are drug expiration dates fact or fiction?

People commonly think that the stamped dates found on the packaging of eggs, dairy, poultry, meat, and other food products are “expiration dates.” They’re not. Rather, these dates indicate when the product in question is “best used by.” Where an expiration date alerts the consumer to the last day a product may be safely consumed, a “best used by” date informs the consumer to when a product may begin to lose its freshness, taste, aroma, or nutritional value.

Unlike Food Product Dating, which is voluntary, federal law requires that drugs be stamped with expiration dates. But, like Food Product Dating, these expiration dates are more akin to “best used by” dates. They are simply a guarantee that the drugs will remain good until the listed date.

The US healthcare system is the most expensive healthcare system in the world. According to ProPublica, nearly $765 billion per year is wasted on healthcare. This waste comes in many forms, including the practice by pharmacies and hospitals of tossing out expensive meds that are inaccurately thought to be expired. In fact, “expired” medicines can remain potent decades after their manufacture.

The issue

You’ve likely been asked by a patient at some point during your medical career whether drugs expire. It’s a good question—and one that has been raising interest from various stakeholders over the past several years.

In a review article published in JAMA, expiration date was explained as follows:

“The date does not necessarily mean that the drug was found to be unstable after a longer period; it only means that real-time data or extrapolations from accelerated degradation studies indicate that the drug in the closed container will still be stable at that date. Most drug products have a labeled shelf life of 1-5 years, but once the original container is opened, the expiration date on that container no longer applies.”

Of note, there have not been any reports of toxicity after consumption or other use of expired drugs in current formulations.

From a legal perspective, drug companies don’t recommend using medications after the dates listed on their labels.

The American Medical Association has looked into the issue and found that the shelf lives of many drugs extend well past their dates of expiry.

The profligate cost of dumping perfectly good meds has not been lost on the US military, specifically the US Department of Defense—which, in coordination with the FDA, runs the shelf-life extension program (SLEP) and maintains the Strategic National Stockpile (SNS). To be ready for anything, such as a public health emergency, the federal government stockpiles pharmaceuticals in their original packaging.

The research

In a SLEP report summarizing data for 3,005 lots representing 122 different drug products dating back to 1986, 88% of the lots were extended past their original expirations dates. Furthermore, only 18% were discarded secondary to failure. 

Although a bit mealy-mouthed, here is the conclusion of the study:

“The SLEP data supports the assertion that many drug products can be extended past the original expiration date, but this additional stability period is highly variable. Due to the lot-to-lot variability, the stability and quality of extended drug products can only be assured by periodic testing and systematic evaluation of each lot. The results of this stability program can only be related to products that have been carefully stored in their original sealed container closures.”

Furthermore, in another study, the drug contents of flucloxacillin capsules, cefoxitin injection, captopril tablets, and theophylline tablets remained 98% intact 18-170 months past their expiration dates.

In another JAMAstudy, researchers examined the stability of aged drugs that were discovered in their unopened original packaging in a retail pharmacy. The 8 unopened medications, which had 15 different active ingredients, had expired 28 to 40 years prior to the investigation. In total, 12 of 14 tested drug compounds retained ≥ 90% of their concentrations per their labeling, including codeine, hydrocodone, and acetaminophen. Notably, however, aspirin lost nearly all of its active concentrations.

“The most important implication of our study,” wrote the authors, “involves the potential cost savings resulting from lengthier product expiration dating.”

It should be noted that drugs in suspension—like epinephrine—do lose their potency over time; thus, expiry dates should be followed for EpiPens and the like.

The stability and quality of expired medications varies greatly. And although no toxicities have been reported as a result of using expired drug products, drug potency may be affected. Physicians are urged to err on the side of caution, as are patients.