Frequently Asked Questions(FAQs) on Drug Expiry Dates

In this article, we respond to the following Frequently Asked Questions(FAQs) on Drugs:

1. Do drugs expire?

2. What does the expiration date for drugs mean?

3. Is taking an expired drug dangerous to my health?

• Do Drugs expire?

All drugs get to a point when they expire.

Although most regulatory authorities advise that a drug must be used before its documented expiry date, some research has indicated that drugs can retain their physical stability and chemical potency many years after their expiry date. However, further research needs to be done to inform this reliably. (1)

This means that when your drug expires, there is no guarantee that it will be safe and effective beyond this date. (2)

• What does the expiration date for drugs mean?

The expiration date is the period within which a drug is known to remain stable. Within this period, the drug retains its strength, quality, and purity when it is stored according to the specified storage conditions. This date is established when a drug application submitted to the Regulatory Authorities with a proposed expiration date, storage conditions and the relevant tests conducted is approved. (3)

The expiry date also assures that the labelled potency will last for at least the stated period. (4)

• Is taking an expired drug dangerous to my health?

 The effectiveness of a drug decreases over time, significantly beyond the expiry date. The drug’s potency decreases due to the potential changes in a drug’s chemical composition or a decrease in its strength. This can be a major health concern, especially when treating an infection, for example, with an antibiotic. Treating infections with drugs with reduced potency poses the risk of antimicrobial resistance failing to treat an infection, leading to more serious infections and severe complications. In cases of blood thinners used for blood clots, less potent drugs can lead to serious health complications such as a heart attack or stroke. (4)

Since there is no guarantee for the safety and effectiveness of a drug after its expiry, Do not take your medication once it expires.

REFERENCES

1. Drugs past their expiration date. Med Lett Drugs Ther. 2015 Dec 7;57(1483):164–5.

2. Sharma S, Sharma AK, Moe HW, Khanapure A, Mohan P. A study to investigate the chemical potency, physical stability, and efficacy of analgesic agents over a period of two years post their expiry date. Medical Journal Armed Forces India [Internet]. 2022 Sep [cited 2023 Oct 19];78:S194–200. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0377123721000757

3. Center for Drug Evaluation and Research, US Food and Drug Administration. Expiration Dates – Questions and Answers [Internet]. 2022 [cited 2023 Oct 19]. Available from: https://www.fda.gov/drugs/pharmaceutical-quality-resources/expiration-dates-questions-and-answers

4. Gikonyo D, Gikonyo A, Luvayo D, Ponoth P. Drug expiry debate: the myth and the reality. Afr Health Sci. 2019 Sep;19(3):2737–9.