The question is common and it seems so simple. Do we need to worry about medicines going bad if they are used beyond their discard date?
The answer is a bit more complicated than you might think. Readers who have thought about this carefully have made some helpful observations. You may be surprised to learn that many of your pill bottles do not come with a true expiration date.
Why Are Pharmacists Using a Discard Date Instead of the Expiration Date?
Q. Why doesn’t the pharmacy put the actual expiration date of medication on the patient’s bottle? It should come from the big bottle they took the medication from. They always put the discard date as one year from the date of dispensing, even if the source bottle has an expiration date years in the future.
Medications are expensive, and some people throw them away after a year, even though they still might be good. The parties that benefit are the pharmaceutical companies and the pharmacies.
The losers are patients, insurance companies and the country as a whole for wasting money on unneeded things. Can anything be done about this practice?
Should the Law Be Changed?
A. We have been badgering the Food and Drug Administration about this problem for years with no resolution.
If a patient wants to report an adverse reaction to the FDA, they need to fill out Form 3500B. It requests an expiration date along with the lot number and NDC number.
It is rare for pharmacies to put the expiration date on the label if they transfer the pills from the manufacturer’s original container. That means patients have no way of knowing the true expiration date.
On the other hand, if medication is dispensed in the drug company’s original packaging, the law requires an expiration date along with lot number and NDC number (StatPearls, May 1, 2023). We believe this should be available for all dispensed medications.
This Problem Is Not New:
Years ago, a reader of this column sent a question on a very similar topic.
She asked:
“When I picked up a prescription from the pharmacy, the pharmacy label had a ‘use before’ date of 09/04/10. The manufacturer’s label, under the pharmacy label, had an ‘expiration’ date of Dec 2012. Why is this?”
“Use-by” or Discard Date Differs from Expiration Date:
We pointed out that the laws in many states require the one-year “use by” date. Of course, pharmacists also find it convenient. After all, computers easily generate a date one year from the dispensing day when printing the label. This date rarely coincides with the manufacturer’s actual expiration date.
Our answer generated controversy, especially among pharmacists. Several took offense at the suggestion that convenience would play any role. In addition, several pointed out, quite correctly, that state law in many places mandates the one-year discard date.
One gentleman objected to any idea of paying attention to the manufacturer’s expiration date:
“I have been a pharmacist in New Jersey for 50 years, and I think your explanation is off-base. The manufacturer’s expiration date assumes that the drug remains sealed in the original bottle under carefully controlled conditions.
“Once the patient opens the bottle and stores it in a bathroom or kitchen, those conditions don’t apply. The heat and humidity will cause rapid deterioration. People may assume that it is all right to use a drug up to the manufacturer’s expiration date, and that would be a mistake!”
Drug companies do test their drugs for stability under controlled conditions. Most drugs have an established shelf life of one to five years, but research shows that they often last much longer.
Conditions That Could Speed Drug Degradation:
Extreme conditions can lead to problems, though this is not always due to improper storage by the patient. Mail order prescriptions are frequently exposed to extreme temperatures even before the patient receives them. When pills sit in a mailbox for hours they may bake or freeze, depending on the time of year.
There’s another issue that has been bugging us for years. The companies that make the raw materials for most or our medications are abroad. For example, China is a major manufacturer of active pharmaceutical ingredients (APIs).
The API manufacturer then ships those chemicals to drug manufacturers in places like India, Thailand or Slovakia. How are they transported? Who’s paying attention to temperature and humidity?
Once the chemicals arrive in India, how do they get from the port of entry to the manufacturing plant? Is anyone keeping track?
And after they leave as “finished pharmaceutical products” how are they transported to the departure port? Are they put in temperature- and humidity-controlled containers? If they are shipped on cargo ships, does someone monitor the conditions. How about when they arrive in a port like Los Angeles or Houston and have to wait for customs inspectors?
The chain of custody for your medicine is incredibly complicated. We fear that the FDA is not monitoring every link in the chain.
What If You Disregard the Discard Date?
Many people worry that medication past its expiration date will morph into something dangerous that could be harmful. Fortunately, a review from The Medical Letter on Drugs and Therapeutics (July 27, 2020) lays that fear to rest.
There are no reports of harm from taking a medicine that has exceeded its expiration date. In many cases, drugs retain their potency for up to five years after the manufacturer’s expiration date.
Of course there is the see no evil, speak no evil concern. There have not been very many stability studies in recent years. The FDA does virtually no testing.
The Medical Letter article cited above cites this study from 1997 (Pharm J):
“Storage in high heat and/or humidity can accelerate the degradation of some drug formulations, but in one study, captopril tablets, theophylline tablets, and cefoxitin sodium powder for injection, stored at 40°C and 75% relative humidity, remained stable for 1.5-9 years beyond their expiration dates.”
We would like to see something a lot more recent and comprehensive.
Beware Expired Epinephrine!
One important exception is injectable epinephrine found in drugs such as AdrenaClick, Auvi-Q or EpiPen. This medicine is used to reverse a life-threatening allergic reaction (anaphylaxis). Patients learn how to inject themselves in an emergency, but if the epinephrine is past its expiration date, it may not be potent enough to do its life-saving job. Consequently, such self-injectors should be replaced regularly.
Liquid medicine should never be allowed to freeze and medicine should be stored away from heat and humidity. That means not in bathroom medicine cabinets.
Ask the Pharmacist:
If you want to know the manufacturer’s expiration date for your medicine, ask the pharmacist to put it on the label when you hand in your prescription. That is what this reader recommends.
Q. I read your column about a person concerned about a prescription that was a couple of months past its use-by date. Whenever I receive a prescription from a pharmacy, I ask for the date on the bottle the medication was dispensed from so I can record that date on my prescription bottle and prescription documents. That way, I’m not constrained by the 1-year time frame most pharmacists put on the bottle.
I also save money because I’m not throwing away perfectly good medication and getting new prescriptions filled. I hope others find this helpful.
A. Thank you for the suggestion. If you make your request at the time you give in your prescription, the pharmacist can allow for the extra time it takes to note the manufacturer’s expiration date. In some states, pharmacists are legally required to display a one-year use-by date, but they are not forbidden to give you the additional information you request.
