Years ago, I bought a bulk container of Aceteminophen (regular OTC). I was digging through my medicine cabinet and uncovered an unopened 600 ct bottle with expiration in 2003. I have another partial bottle of similar vintage.
Since that time, I either use Ibuprofen, or 8hr Tylenol, which is why I have these unused items.
So, what should I do to dispose of them? I know not to dump the pills down the toilet. Is there some way I should dispose of them? Turn them in somewhere? Or just pitch them in the trash in their bottles?
You buy a bottle from the drug store and then take the expired bottle back and say “Look you sold me an expired bottle from 2003” and get your money back
I have seen some debate on this. Many drug stores will take back expired prescription medicines. See it one will take it.
Don’t throw it in the trash. It is a hazard to children and pets. I couldn’t believe some idiot on a dog forum posted a link to a Chicago Tribune feature saying add grease or something to medicine to make it unattractive. Anybody that has any business postign to a dog forum should know that that would make it very attractive to dogs. In general, I can’t believe much of the garbage I read on the net. See below.
While this *may *be true in the case of Tylenol, it’s important to remember that it is not necessarily true of all drugs, even “every day, over the counter” ones. The fact is, after the expiration date on the label, there is no data whatsoever on what happens to the drug over time.
The manufacturer is not required to test longer than the minimum stability regulations (about 3 years testing protocol IIRC), and so they don’t. A drug that passes stability testing at 101.9% assay on Day 1 might pass stability at 98.1% on the last day of testing, but that doesn’t mean that 3 years beyond that the drug is still safe. Anything from simply losing effectiveness (potential health risk due to under-medicating diseases) to buildup of toxic/or otherwise pharmaceutically active but undesired products could have occurred. No one knows, no one will ever bother to check, and so taking an expired medicine is done at your own risk.
Of course, it isn’t a time bomb. A day expired? Safe. A week? Sure. A month? A year? 6 years? Sooner or later it isn’t safe, because these things do degrade, just sometimes very slowly.
It’s like food. No one is surprised when food spoils, even if stored well, and most people will feel safe eating something a day or two past the expiry date. But we all know there’s some point where it isn’t safe any more, so best to throw it out. The difference is that we can generally see or smell the degradation of food; but just because you can’t see it, doesn’t mean it isn’t happening in drug products.
How many times have I posted essentially this on these boards over the years, I wonder?
Is this really the case? Doesn’t it seem like a question SOMEBODY would want the answer to, if only out of curiosity?
What, for example, would somebody like the CDC say about this situation? “You took ten-year old expired drugs? Uh… we don’t know what will happen, sorry. Good luck.”?
I’m just surprised that an industry which lives or dies by the statistical effects of its drugs wouldn’t bother to try to answer such a basic question.
Surely the explanation as to why this isn’t done is that it would be an outstandingly expensive exercise of negligible benefit? Not to mention the ethical difficulties: you would have to try these drugs out on real people, after all!
The regulations don’t require it. To validate a drug for market, you have to show X years of stability following manufacture (the X varies, but so do the storage conditions; long-term room temperature stability for something like Enbrel obviously failed, hence the 3-month fridge storage expiry date…some of these things are amazing medications but are damn hard to keep in a stable form).
IIRC, a typical stability protocol will have a lot tested at 3 months, 6 months, 12 months, 2 years, 3 years after manufacture (maybe with intermediate points in between) and testing product stored at 5C/Ambient relative humidity, 25C/Amb RH, 30C/60% RH, 40C/75% RH, and maybe other variants depending on the drug. A full battery of tests is done; assay, impurities, dissolution, ph, volume/minimum fill, colour/appearance, etc. Companies know exactly what happens to the products over that time frame. Isn’t that enough?
What reason would a company have to continue to test beyond the timeframes established by the FDA/TPD/equivalent? The CDC can take it up with the FDA, but frankly if you don’t use a drug before it expires then either buy a smaller package or buy something else. Remember, a company needs to be able to profit, in order to keep manufacturing and also research new drugs.
That said, the degradation products are known; it’s part of the formulation study protocol. Candidate drugs are forced in all kinds of chemical environments to degrade, to see what they will break down into. The toxicology/pharmacology of these degradation products are somewhat known (that’s an area I didn’t work in, so I’m not comfortable saying more than that). So treatment for having consumed an expired/degraded drug and having unwanted effects from it will be in response to the known major degradation products, or to the known metabolites in the case of overdose (as I understand it, IANAD).
That’s why there’s an expiry date - it MEANS “this drug is expired, don’t take it.” I expect that the liability probably falls on the person taking it, not on the manufacturer, especially 10 years past expiry.
Why isn’t 3 years long enough? Would 5 do? 10? I think no matter what expiry dates and stability regulations existed, people would still be asking whether it was safe to take expired medicine (to the OP: I know that wasn’t the question asked, but the topic came up in the thread…)
[rant, not directed at Reply or anyone in particular, but I’m in this kind of mood]
Really, this always surprises me. Think about it for a second; the purpose of drugs is to fuck with your body’s chemistry. That’s what you WANT it to do, to cure a disease, alleviate symptoms, whatever.
It’s absurd to think that a drug will target only one specific thing, one specific disease, given as most illnesses aren’t due to one thing only; if it were that simple, we’d have cured most things by now. People panic and bitch when drugs cause side effects, as if that’s somehow unexpected. It’s fucking up your body’s chemistry, as desired, but also fucking up your body’s chemistry!
When they degrade, they degrade into things that can also fuck up your body’s chemistry, given as degradation products are often drugs in their own right, though not always good ones. Why is that surprising? So companies check that a drug will only fuck things up in a certain way for X amount of time, with w, y, z, side effects, but is really isn’t surprising that after that time, once they expire, more things might happen that could fuck with your body’s chemistry.
