Drug Expiration Dates - Are Expired Drugs Still Safe to Take?
Medically reviewed on Jun 11, 2018 by L. Anderson, PharmD.
Patients often have questions about drug expiration dates:
- Can I safely take a medication if it has reached the drug expiration date?
- Are there recommendations about the best way to store my medications?
- Which drugs should never be used past their expiration date?
For many patients, these questions arise because medications can be expensive and it is costly to frequently replace expired but unused medications.
What does an expiration date mean?
The expiration date is the final day that the manufacturer guarantees the full potency and safety of a medication. Drug expiration dates exist on most medication labels, including prescription, over-the-counter (OTC) and dietary (herbal) supplements. U.S. pharmaceutical manufacturers are required by law to place expiration dates on prescription products prior to marketing.
For legal and liability reasons, manufacturers will not make recommendations about the stability of drugs past the original expiration date.1 However, for most drugs, it's just an arbitrary date, usually 2 or 3 years out, that the manufacturer selects to test drug stability. In all actuality, the stability of the drug may be much longer, but no one tests it.
The expiration date of a drug is estimated using stability testing under good manufacturing practices as determined by the Food and Drug Administration (FDA). Drug products marketed in the US typically have an expiration date that extends from 12 to 60 months from the time of manufacturer. Once the original container is opened, either by the patient or the health care provider who will dispense the drug, that original expiration date on the container can no longer be relied upon.2 However, the actual shelf life of the drug may be much longer as stability studies have shown.3
At the pharmacy, "beyond-use" dates are often put on the prescription bottle label given to the patient. These dates often say "do not use after..." or "discard after..." and are required by the Board of Pharmacy in many states. These dates are typically one year from the date of fill. But why would these expiration dates be different? According to the manufacturer, the stability of a drug cannot be guaranteed once the original bottle is opened. Heat, humidity, light, and other storage factors can affect stability. Plus, pharmacies, both retail and hospital, nursing homes, and consumers toss away billions of dollars of medications each year based on stamped expiration dates on stock bottles. In fact, according to a report from Allen9, hospitals alone discard over $800 million in drugs annually.
The United States Pharmacopeia (USP), the body that sets the standards for pharmaceutical quality in the U.S., recommends using "beyond use" dates. The "beyond use" date would never be later than the expiration date on the manufacturer's bottle.4 However, the expiration date on the prescription bottle from the pharmacy is usually one year from the date it was filled; again, another arbitrary date.
Do expired medications lose their potency?
The American Medical Association (AMA) concluded in 2001 that the actual shelf life of some products is longer than the labeled expiration date. The AMA stated the best evidence resides in the Shelf Life Extension Program (SLEP) undertaken by the FDA for the Department of Defense.2,7
The original purpose of the SLEP program was twofold: to determine the actual shelf life of stockpiled military medications for future use, and to save government dollars.5 Over 3000 lots, representing 122 different drug products, were assessed in the SLEP program. Based on stability data, expiration dates on 88% of the lots were extended beyond their original expiration date for an average of 66 months. Of these 2652 lots, only 18% were terminated due to failure. Examples of common drug products that were tested with no failures included amoxicillin, ciprofloxacin, diphenhydramine, and morphine sulfate injection. Drug expiration extension dates on these products ranged from 12 months to 184 months (over 15 years).8 Biologics are not included in the SLEP program.
These results suggest that many drug products may have extended shelf lives beyond their expiration date. However, it is difficult for any one consumer or health care provider to know which product could have an extended shelf life. The ability for a drug to have an extended shelf life would be dependent upon the actual drug ingredients, presence of preservatives, temperature fluctuations, light, humidity, and other storage conditions. Additionally, the drug lots tested in the SLEP program were kept in their original packaging. Once a drug is repackaged into another container, as often happens in the pharmacy, the shelf-life could decline due to environmental variations.3
Is it safe to take expired medications?
Studies and case reports are lacking on this topic. In 1963, a report was published that tied degraded tetracycline use with a form of renal tubular (kidney) damage known as "Fanconi Syndrome"; however, that formulation of tetracycline in no longer marketed in the U.S.1, and many medical experts question the results of this case report.
Solid dosage forms, such as tablets and capsules, appear to be most stable past their expiration date. Drugs that exist in solution or as a reconstituted suspension, and that require refrigeration (such as amoxicillin suspension), may not have the required potency if used when outdated. Loss of potency can be a major health concern, especially when treating an infection with an antibiotic. Additionally, antibiotic resistance may occur with sub-potent medications. Drugs that exist in solution, especially injectable drugs, should be discarded if the product forms a precipitant or looks cloudy or discolored.1
Expired medications that contain preservatives, such as ophthalmic (eye) drops, may be unsafe past their expiration date.1 Outdated preservatives may allow bacterial growth in the solution.
Can you use an expired EpiPen?
The manufacturer states EpiPen autoinjectors should not be used after the expiration date as the epinephrine has been shown to lose its potency.1 Epipens are used in life-threatening situations like anaphylaxis, so there can be a major health threat with an expired EpiPen.
However, 2017 research on expired EpiPens has been published.11 A small evaluation of almost 40 expired, unused EpiPens gathered from patients showed that the pens retained 80% of their initial dose of epinephrine, some for up to four years past the expiration date on the device. The lowest level of epinephrine was found in an EpiPen Jr. 30 months past its expiration date; it retain over 80% of it's original epinephrine dose. About 65% of the EpiPens and 56% of the EpiPen Jrs. contained at least 90% of their initial dose.
In a life-threatening allergic situation, if there is no other option, use of an expired EpiPen should be considered if it is the only auto-injector available and there are no discoloration or precipitates seen in the solution. In this case, the potential benefit of saving a life is greater than the potential risk of death by not using it all.6,11
Which medications are unsafe after their expiration date?
There's really no way to know unless drugs are tested, but here are some common sense measures:
- Insulin is used to control blood sugar in diabetes and may be susceptible to degradation after its expiration date.
- Oral nitroglycerin (NTG), a medication used for angina (chest pain), may lose its potency quickly once the medication bottle is opened.
- Vaccines, biologicals or blood products could also be subject to quick degradation once the expiration date is reached.
- Tetracycline may produce a toxic metabolite, but this controversial among reseachers.8
- Medicines that looks old: powdery or crumbling medicine, drugs with a strong smell, or dried up medicine (as in the case of or ointments or creams) should be discarded.
Proper storage of medications may help to extend their potency. The bathroom and medicine cabinet are not ideal places to store medications due to heat and humidity. Similarly, medications should not be left in a hot car or glovebox, or in freezing weather. Medications remain most stable in dry, cool spaces away from light. Keep the prescription bottle caps tightly closed and always keep medications out of reach of children and pets.
Another important point, especially considering the national opioid epidemic. Discard unused or expired controlled substances like hydrocodone and acetaminophen (Vicodin, Lotab, Norco) or oxycodone (Oxycontin) as soon as possible due to the risk for overdose, theft, or diversion of the medication. Plus, learn about the National Prescription Drug Take Back Day held twice per year in your city as a safe way to dispose of these prescription medications.
Can I take an expired medication?
Should patients use expired medications or not? It's always best to use medications that are NOT expired; it's just the safest route. If a medication is essential for a chronic and potentially life-threatening disease, for example, a heart condition, cancer treatment, seizure, or life-threatening allergy, it is probably wise to get a new prescription before it expires and keep up with refills as needed.
However, if a medication is needed, and the patient is not able to replace the expired medication, there is no evidence that it is unsafe to take the medication in most cases.1 The patient should be aware that it may not produce the desired therapeutic effect. If this is the case, a new prescription is needed.
If an expired medication is for a minor health problem, for example, for a headache, hayfever, or mild pain, it may also be safe to take it, although drug potency might not be 100% and it may not work as well. For example, if using ibuprofen (Advil) or acetaminophen (Tylenol) that's outdated does not relieve your headache, it may have lost its potency. Research has shown many military stockpile medications retained 90% of their potency in their original stock bottle.3,8 However, storage conditions of these medications were optimized for temperature and humidity, and probably do not mimic the typical storage conditions of the average household prescription bottle.
If an expired medication is taken, and the patient notices the drug has no effect, the medication should be replaced. Some drugs are probably less likely to be safe if they're expired:
- a biologic product
- a refrigerated liquid
- eye drops
- a specially compounded medication
- if it looks like it is degraded or cloudy, or has a noxious smell, it should be discarded and replaced.
If questions still remain about how to handle an expired medication, it is wise to speak with your pharmacist or physician, who can offer additional information and advice.1
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1. Anon. Drugs Past Their Expiration Date. The Medical Letter on Drugs and Therapeutics. 2009;51:101-102. Accessed May 29, 2018 at https://www.ncbi.nlm.nih.gov/pubmed/26633684
2. American Medical Association. "Pharmaceutical Expiration Dates." Report 1 of the Council on Scientific Affairs (A-01). July 25, 2001.
3. Lyon RC, Taylor JS, Porter DA, et al. Stability profiles of drug products extended beyond labeled expiration dates. J Pharm Sci 2006;95:1549-60. Accessed May 29, 2018 at https://www.ncbi.nlm.nih.gov/pubmed/16721796
4. American Society of Health System Pharmacists (ASHP.org). Q&A on Proposed USP Chapter 797 Revisions with E. Clyde Buchanan.
5. Woods M. Drugs may outlast label date. Post-Gazette National Bureau. May 30, 2005.
6. Simons FER, et al. Outdated EpiPen and EpiPen Jr autoinjectors: past their prime? J Allergy Clin Immunol 2000;105:1025. Accessed May 29, 2018 at https://www.ncbi.nlm.nih.gov/pubmed/10808186
7. Expiration Dating Extension, U.S. Food and Drug Administration (FDA). Updated: March 2, 2018. Accessed May 29, 2018 at https://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCMLegalRegulatoryandPolicyFramework/ucm411446.htm
8. Drug Expiration Dates - Do They Mean Anything? Harvard Health Publishing. Harvard Medical School. August 13, 2017. Accessed May 29, 2018 at https://www.health.harvard.edu/staying-healthy/drug-expiration-dates-do-they-mean-anything
9. Allen M. That Drug Expiration Date May Be More Myth Than Fact. NPR. July 18, 2017. Accessed May 29, 2018 at https://www.npr.org/sections/health-shots/2017/07/18/537257884/that-drug-expiration-date-may-be-more-myth-than-fact
10. Diven DG, Bartenstein, DW, Carroll, DR. Extending Shelf Life Just Makes Sense. Mayo Clin Proc. November 2015;90:1471-1474. Accessed May 29, 2018 at https://www.mayoclinicproceedings.org/article/S0025-6196(15)00667-9/fulltext
11. Expired EpiPens May Still Help Save a Life: Study. Drugs.com. May 9, 2017. Accessed May 29, 2018 at https://www.drugs.com/news/expired-epipens-may-still-help-save-study-65503.html