Pharmaceutical Use By date

Recently I got stung/bitten on the ankle, which continued to give me grief after several days. So, I sought advice from local chemist. Was recommended 'Trust Cetirizine Antihistamine 10mg. He was very insistent on it being within date.
Wasn’t till I got home and opened up the bag that I discovered the pack only had 7 months shelf life. I was a bit staggered, I thought most over the counter drugs had a shelf of several years.
I e-mailed the maker Pharacor Ltd, and their response, was its still got 7months shelf life. I replied asking what the from new shelf life was and the reply equally bluntly was, 3 years.
The attitude surprised me. I assume if it only had 1 month remaining it would have been much the same response.

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Unless you are subject to being stung or bitten on a regular basis into the future, why is an expiry date less than the full three years an issue?
Can’t expect chemists to only stock brand new medicines.
With seven months left, that is plenty in this situation.


Usually a treatment of a mild allergic reaction using antihistamines (such as Cetirizine) is only needed for a short duration (number of days as recommended by the pharmacist) and well within the 7 months to expiry. 7 month expiry will be irrelevant to the treatment of your condition as its use will he immediate rather than sometime in the future.

I suspect the pharmacist would have also said if the reaction doesn’t improve over a number of days, to seek further medical attention. This is common advice given at the time of dispensing.

Medicines have expiry dates to ensure they are effective and safe at the time of treatment. And like any products which have an expiry/use by date, the time to this date is dependent on the storage life of the product and how long it has been stored since manufacture.

And 1 month until expiry would also possibly been okay for your treatment as well.

If one expects every medicine to be dispensed with close to the maximum possible expiry date (such as 3 years), this is an unreasonable expectation as pharmacies would no longer keep many medicines on their shelves. If they did many would need to he thrown out to meet this requirement. This would increase waste and costs of medicines will increase to cover the cost of the waste.


It is often the case that drugs have a shelf life of years. I don’t see why 7 months is such a problem. Do you feel short-changed getting only 7 months out of three years?

Another aspect of this is that the stated shelf life may reflect a reduction of effect to a given level. I understand that such ratings can be quite conservative in some cases. It is unlikely that when it reaches three years there is no effect at all, so what you have may still be useful for months after the clock ticks over, just not as potent as when new.


According to Med Safe, the shelf life of Cetirizine is 3 years when stored below 30C.
The question could be asked where and at what temperature was it stored during all that time previously?
BTW it seems to be the same as Zyrtec which can be bought at supermarkets where we can choose the packets with the longest expiry date.:slightly_smiling_face:


Perhaps we can actually consider the implications of Pharma Use By Dates.

So, staying with this particular drug type. As someone who isn’t allergic to say bee stings, I am nevertheless like many others susceptible to many insect bites and stills, mozzies, sand flies, wasps, bees,etc, all lead to me swelling up with irritation for several days. So, I carry antihistamines in the car, travel bag, when I attend outdoor events like BBQs, etc, etc.

Apart from that many people also need drugs for hundreds of conditions, and carry them as a precaution. But are they aware that they may only have a few months remaining on their use by period when they buy them?

How long a period is reasonable for purchaser to have in terms of use by for drugs.

Are these use by dates arbitrary? Or do they actually have to prove to the authorities that they do actually degrade over time, even when stored in pressure sealed packaging?

Many prescription drugs, particularly antibiotics, need to be taken, used, within the prescribed time. Hence, leaving these hanging around, and keeping them for the next occurrence, is detrimental to public health. But, that argument by pharmacists and GPs not to keep or use old drugs, isn’t about use by dates. But, it may well enable companies to put very short use by dates on drugs that don’t require such dates at all, ever! I don’t know. Maybe Choice does?

Didn’t know that about Zyrtec, thanks! I’m sure they are just stored on the shelf, not in controlled temp areas.

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Zyrtec is the brand name for Cetirizine. It is usually much more expensive than generic Cetirizine. Not a recommendation per se, but I buy a number of products from this company and they are always 100% as advertised.


Sometimes the way someone posts influences the responses.

My impression was this was something that had just happened to you, and went to the chemist for advice on what could help.

Now you say you regularly carry antihistamines around because you are allergic to bites and stings. In that case how do you not know about OTC products like Zyrtec, which is Cetirizine?

There’s also a cheaper generic for Zyrtec.


It seems that you are not happy that only 7 months remain on your drugs. If so what period would be acceptable? If you are happy with 7 months what is the problem?

My understanding is they are not. If you have a look at the TGA web site it depends on the class of drugs.

Well what is it about?

You are going from speculation, that you say you know nothing about, to hinting that the public are being cheated by having arbitrarily short use-by dates put on drugs. I don’t see that you have given any reason for that so far.


As you had an ailment (stung/bitten on the ankle) giving you grief, the antihistamines were recommended by the pharmacist to treat the presented condition. One week to expiry may have been okay if treatment was say for 5 days. You won’t be taking the medication for 7 months - as the dispensed amount would not have been more than 210 tablets. If more than 210 tablets were dispensed, this would be very concerning for a short term treatment.

It isn’t defending or supporting the manufacturer or pharmacy. It is acknowledging that the antihistamines provided by the pharmacist were fit for purpose for what they were dispensed for.

If you had said that you visited the pharmacy to get antihistamines for the off chance of having a reaction to something in the future and the expiry was unreasonably short, when the antihistamines are known to have a long expiry date, I would then possibly agree that this is unacceptable. It could be argued the pharmacy might be getting rid of old stock to an unwary customer. There would be grounds to challenge the pharmacist to why medication was dispensed which had unrealistically short expiry when it was needed in the longer term. Your experience is different to such and it is very reasonable to be dispensed with antihistamines with 7 months until expiry.

In relation to your other points, it is worth reading…

Medicines dosage usually is very small and is within that which is safe and has efficacy. Over time the active compounds can denature/degrade and the amount of active ingredient becomes unknown. It might be at levels which are no longer effective or have denatured compounds which may have different effects to that originally intended (in the case of antibiotics, it could lead to resistance) This is why expiry dates are used on medications.

Cetirizine has a maximum storage temp of 30°C and storing in a car etc wouldn’t be advised as it may impact on the life and efficacy of the compound. There could be health risks of taking Cetirizine stored under such conditions.


I have a different angle to add to all the good points made.

Pharmacor is a generic manufacturer (not the originator who has had the product for many years) and when they first registered it, it may have little real-time stability data to submit to TGA and it would only support a 12 month expiry date, they may have since submitted extra data and had a TGA approval for an increased shelf life of 3 years.

Generally most pharmacists don’t like stock of less than 6 months left, for the very annoyance it has caused you. For antihistamines tabs - they are often now and then medications, so expiry is important, but the pharmacists don’t have time to check the shelves for each box.

Also, pharmacy staff are usually asked to put the newer stock at the rear so patients don’t inadvertently get an older box, but this may not have happened.

I have a general recommendation for Choice to make to TGA and the Minister - that expiry dates should be clearer on self-selected stock, particularly for those with not so good eyesight, the TGA maybe following international norms on this aspect of labelling, but it is important.


Even if medicines are past their use by date they’re still effective. I know from experience.

Hi Parmelita, yes you may be able to get away with it, but…

The expiry data is most often set when the active ingredient drops to less than 92.5% or 90% of the labelled content. HOWEVER, for example, the break down products of penicillin are more likely to cause allergic reactions and the breakdown products of tetracyclines, another common group of antibiotics have caused kidney failure - so the increase in quantity of these break down products over time post-expiry creates a sometimes unknown additional risk for certain medicines.


These potential problems of expiration Dates have been around for many years when it was noted that while food products had a ‘use by Date’ or similar, that wasn’t the case for oral tablets. About 1979 it was legislated in USA that drugs must have an expiration date. The problems was there was no data on this issue.

Most of what is known about drug expiration dates comes from a study conducted by the Food and Drug Administration at the request of the military. With a large and expensive stockpile of drugs, the military faced tossing out and replacing its drugs every few years. What they found from the study is 90% of more than 100 drugs, both prescription and over-the-counter, were perfectly good to use even 15 years after the expiration date.

So, the expiration date doesn’t really indicate a point at which the medication is no longer effective or has become unsafe to use. Medical authorities state if expired medicine is safe to take, even those that expired years ago. A rare exception to this may be tetracycline, but the report on this is controversial among researchers. It’s true the effectiveness of a drug may decrease over time, but much of the original potency still remains even a decade after the expiration date. Excluding nitroglycerin, insulin, and liquid antibiotics, most medications are as long-lasting as the ones tested by the military. Placing a medication in a cool place, such as a refrigerator, will help a drug remain potent for many years.


Helpful and interesting reply.

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Not germane to the meds discussed but the TGA has extended the expiration of some COVID related products and meds but the dates on the boxes are unchanged.

One can never be sure without looking at the TGA site or asking the chemist although I’ll punt 99+% are not extended, but.

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Pekay, thank you, a good addition!

I will add that each company has to do their own expiry testing for their own products, temperature, humidity, the excipients, air or medicine leakage through the lid, the rubber bung in an injection vial and the container and/or blister type can all influence degradation, development of crystals or other particulates etc. No evaluators in TGA rely on the US FDA assessment for stability and they review the data independently.

…and all sorts of different things come up in the real world - I once had a lady who kept her digoxin 62.5mcg (a 100 tablet glass bottle) in the fridge. When she came in and asked what was wrong with them, I noted they had turned from blue to white and had mould growing on them - from the condensation on the glass bottle in the humid climate each time she put them back in the fridge (her own decision)!

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PhilIT, you probably know this, but the most TGA ever gives is a 5 year expiry, but they have extended their own warehoused pandemic flu antivirals a few times more than a decade ago (after testing that is).

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