Do Medications Really Expire?

Yes, medications do expire, but the expiration date does not necessarily mean that the medication is not effective. As a parent of a child with allergies, I know that expired EpiPens can be a concern. However, it’s important to remember that the expiration date is just an estimate of how long a medication will remain effective. I oftentimes dropped off my son at birthday parties and school with expired medications. Was this alright? Let’s look at the research!

The expiration date is the last day that the manufacturer guarantees 90% potency and safety of the medication.1 After the expiration date, the medication may start to degrade, lose its effectiveness, or even become harmful per the manufacturer. The expiration date is estimated using stability testing under good manufacturing practices as determined by the Food and Drug Administration (FDA).2 Once a bottle is opened, the stability cannot be guaranteed by the manufacturer. Factors that can lessen the stability include heat, humidity, light, etc.

The Shelf Life Extension Program

Commencing in 1986, The Shelf Life Extension Program (SLEP) was created by the FDA for the Department of Defense to evaluate the shelf life of medications that were stockpiled in order to prevent wasteful spending after discarding medications due to expiration dates. The Strategic National Stockpile encompasses large quantities of medicine, vaccines, and medical supplies to protect the American public if there is a public health emergency. Here’s what this program has taught us after evaluating over 3005 lots of medications including 122 different products. Based on stability data, expiration dates on 88% of the lots were extended beyond their original date by 66 months.3,4

However, the rate at which medications degrade varies widely. Solid dosage forms, such as tablets and capsules, appear to be most stable past their respective expiration dates. This raises an important issue, drugs that exist in suspension or have been reconstituted and require refrigeration may not have the same potency after expiration (i.e., amoxicillin suspension). This could potentially be problematic if you were using an antibiotic for an infection and the original potency was reduced. Other liquid solutions including eye and ear drops and topical solutions may undergo evaporation compromising the drugs potency or even enabling bacterial growth.2

Therefore, commonly used medications like albuterol, amoxicillin, ciprofloxacin, EpiPen, diphenhydramine (Benadryl), and over-the-counter are still considered stable past their expiry dates and safe to use. To receive the best medical management, however, discuss the medications listed with your healthcare provider, as they treat a variety of medical conditions.

Medications that are Unsafe post-expiration.

Certain medications are considered unsafe post-expiration including the following:

  • Insulin (diabetic medication)
  • Oral nitroglycerin (heart medication)
  • Anti-coagulants (blood thinners)
  • Biologicals and blood products
  • Seizure and thyroid medications
  • Tetracycline (can cause kidney issues)

If you are unsure whether or not an expired medication is safe to take, talk to your doctor or pharmacist. They can assess the medication and advise you on whether or not it is still effective.

Additional Tips for Storing Medications Safely and Prolonging Their Shelf Life

  • Store medications in a cool, dry place, away from direct sunlight, humidity, and heat.
  • Keep medications in their original containers with the labels intact.
  • Do not mix medications together.

SOURCES:

1. Paauw, D. S. (2023). More on using expired medications. Medscape. Retrieved from https://www.medscape.com/s/viewarticle/996754

2. Anderson, L. A. (2022). Drug Expiration Dates – Are Expired Drugs Still Safe to Take? Retrieved from https://www.drugs.com/article/drug-expiration-dates.html

3. U.S. Food and Drug Administration. (2023, October 20). Expiration dating extension. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/expiration-dating-extension

4. Lyon RC, Taylor JS, Porter DA, Prasanna HR, Hussain AS. Stability profiles of drug products extended beyond labeled expiration dates. J Pharm Sci. 2006 Jul;95(7):1549-60. doi: 10.1002/jps.20636. PMID: 16721796.