Drug Expiration Dates - Are Expired Drugs Still Safe to Take?
You pull a bottle of medicine from your cabinet, but see it expired a year ago. You may ask:
- 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. But is it safe to use medicines past their expiration date?
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 1 to 5 years out, that the manufacturer selects to test drug stability. Once the container of medication is opened after production, that expiration date is no longer guaranteed.11
How are drug expiration dates determined?
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.
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
Do expired medications lose their potency?
The best evidence suggesting that some drugs can last past their expiration date is from the Shelf Life Extension Program (SLEP) undertaken by the FDA for the Department of Defense.2,7,11
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. Potency, pH, water content, dissolution, physical appearance, or presence of impurities were assessed.
- 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, roughly 12% more lots remained stable for at least 4 years after the expiration date. Of these 2652 lots, only 18% were terminated due to failure.11
- 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.
- Potassium iodide, which has been stockpiled in the US for a radiation emergency, has shown no significant degradation over many years.11
- In June 2020, FDA stated that expirations dates could be extended for certain stockpiled influenza antivirals such as Tamiflu (oseltamivir) 75 mg capsules and Relenza (zanamivir) if stored under labeled conditions and for emergency use in individual states.7 Expiration dates could potentially be extended for 15 years for Tamiflu and 10 years for Relenza.7
Also, testing reported in The Medical Letter showed that many medications were still potent decades beyond their expiration dates. The authors note that there are no published reports of human toxicity due to ingestion, injection, or topical application of a current drug formulation after its expiration date.11
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 in a medicine cabinet could have an extended shelf life or expiration date.
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?
The U.S. Food and Drug Administration (FDA) recommends never taking drugs beyond their expiration date as it is risky with many unknown variables. For example, how your drug is stored before you receive it, chemical make-up, and original manufacturing date can all affect potency of a drug.
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 is no longer marketed in the U.S.1, 11, 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
Liquid drugs such as eye or ear solutions, oral liquids, or topical solutions may undergo evaporation of solvents over time.11
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?
Epinephrine is an unstable chemical subject to degradation. 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 (a life-threatening allergic reaction), so there can be a major health threat or death linked with an expired EpiPen.12,13
The FDA requires that epinephrine autoinjector expiration dates ensure that the devices contain at least 90% of the original dose of epinephrine.
- In a study of over 30 pens that had expired up to 7.5 years earlier, the decrease in epinephrine content was proportional to the number of months past the expiration date.6
- Another small study found that out of 46 autoinjector devices, 80% (37 devices) still retained 90% epinephrine content after a median expiration date of two years. Devices up to 6 months past the labeled expiration date maintained 100% of epinephrine content.14
- No data exists on other epinephrine autoinjectors such as Auvi-Q.11
Talk to your doctor about use of an epinephrine autoinjector after its expiration date. In general, it's best to keep up with new injectors before they expire to prevent a mishap due to a subpotent medication.
Epinephrine autoinjectors are often carried in a purse or pocket from place to place and may be subject to variable heat and humidity conditions. Also, be sure to replace any epinephrine injectors that may be stored at your child's school before they expire, too.
In addition, epinephrine autoinjectors or syringes have become more affordable and are covered by most insurance carriers due to the availability of generics at the pharmacy. Manufacturers may be able to offer copays coupons or patient assistance, as well. Learn more about financial assistance here.
Which medications are unsafe after their expiration date?
There's really no way to know if a drug is safe unless its tested for potency, 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 researchers.8
- Medicines that looks old: powdery or crumbling medicine, drugs with a strong smell, or dried up medicine (as in the case of ointments or creams) should always be discarded, expired or not.
- Discard any expired injectable medication. If expired or not, always discard injections if cloudy, discolored or with visible floating particles.
How should I store my medicines to maintain their shelf life?
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.
Most oral, solid 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.
Look at your package insert for proper storage instructions, or ask your pharmacist. Be careful to follow any instructions for refrigeration or freezing.
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, get a new prescription before it expires and keep up with refills as needed. If you take an expired medication and you notice the drug has little or no effect, the medication should be replaced immediately.
These drugs may pose serious problems if they're expired:
- a biologic product
- a refrigerated liquid or other medicine
- eye drops
- injectable medicine
- a specially compounded medication
- any drug that looks like it is degraded or cloudy, or has a noxious smell, should be discarded and replaced immediately; do NOT use.
Ask your pharmacist or doctor questions about expired medications who can offer the best information and advice specific to your situation.1 When in doubt, it's always best to get a new, unexpired medication.
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1. Anon. Drugs Past Their Expiration Date. The Medical Letter on Drugs and Therapeutics. December 7, 2015;57(1483):164-165. Accessed July 22, 2020.
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.
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.
7. Expiration Dating Extension, U.S. Food and Drug Administration (FDA). April 7, 2022 at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/expiration-dating-extension
9. Allen M. That Drug Expiration Date May Be More Myth Than Fact. NPR. July 18, 2017. Accessed April 13, 2022 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.
11. Pumphrey RS, Gowland MH. Further fatal allergic reactions to food in the United Kingdom, 1999-2006. J Allergy Clin Immunol. 2007 Apr; 119(4):1018-9. Accessed July 22, 2020.
12. Posner LS, Camargo CA Jr. Update on the usage and safety of epinephrine auto-injectors, 2017. Drug Healthc Patient Saf. 2017;9:9-18. Published 2017 Mar 21. doi:10.2147/DHPS.S121733. Accessed July 22, 2020.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.