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Insider’s Look at Drug & Vitamin Expiration Dates

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VitaminsAfter my last post on drugs, vitamins and expiration dates, I received an anonymous email from someone who claims to work in the pharmaceutical industry. They wanted to share some insider knowledge on how drug and vitamin expiration dates really work. A lot of it confirms and expands on what I wrote initially but includes some first hand knowledge that corroborates what I’ve only found researching online.

So while I can’t confirm he or she works in the pharmaceutical industry, I have no reason to believe (and I think you’ll agree) what he or she says is true.

As a person who works daily with the production of both Liquid and Solid Dose vitamins and all sorts of OTC pain relievers etc, I would almost consider myself an expert on this topic and wanted to give you the low down.

For all of the types of drugs and vitamins we make, the expiration date only holds one meaning: The date that my company will guarantee the legal claim efficacy of the drug. For example, certain vitamins degrade over time, so we put in a safe “overage” – knowing based on statistical stability data, etc, we will know that in X number of months, vitamin Y will degrade by a certain percentage. Our standard formulation process is to work backwards from 24 months and put in the correct amount of each vitamin, (or drug, same principle) so that at 24 months from the date of manufacture, all the nutrition or drug facts on the box are correct – that 24 month date is the expiration date on the box.

The only way for us to put a longer claim on the box is to have actual stability data (not statistical) – for example, if we haven’t changed the formula of the product or the bottle or tube it goes in for 3 years, and we do a bunch of testing on stuff that was made 3 years ago and it still meets the label claims, we can change the expiration date to 3 years. Unfortunately, this rarely happens because someone is always tweaking a formula or changing packaging materials for some reason or another, so its tough to do.

Oh, one other thing in response to a comment left by one of your readers – companies do not want short expiration dates – yeah, it might be nice to have someone have to go back to the store to by more drugs frequently, but there is way more risk for the company. Right now, I am managing roughly $150MM in finished product inventory, and I want as much time as I can to sell it. As it stands today, Walmart and most other retailers won’t accept product with less than 1 year of dating, so anything we can’t sell in that first 12 months after something’s made is usually destroyed.

If product is destroyed, not only is it a huge waste of money, I also have to make new product to replace what I just threw in the garbage – talk about waste.

Editor’s Note: So in summary, drugs and vitamins do work past their expiration date by quite a margin, but drug makers don’t label it as such because they aren’t able to meet the statutory requirements to prove that it does. I thought it was an interesting insider’s look, I hope you did too.


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36 Responses to “Insider’s Look at Drug & Vitamin Expiration Dates”

  1. fredrick Zinos says:

    Rx products, no matter what the product, must be at 100% of label potency at manufacture and at the expiration date. No exemptions, no exceptions.

    Physicians/pharmacies may elect to remove products that are within expiration dating if they feel that the products were subject to conditions that could have altered the potency and thus the expected outcome of taking the drug. For example ambient heat or humidity or suboptimal storage conditions may influence potency.

  2. jc says:

    I work in pharma indus. and we r importing vitamin from other country. my question is that after the vitamins are manufactured in foreign country, 2years are given to such vitamin and before I receive those vitamin, it takes at least 6months to be ready to be kept in the inventory and another few months in the inventory to be sold due to primary inventory. Which means that these vitamins eventually be left with just little over 1year. What happened was that I changed the package type from Bottle to PTP blister about a year ago. Is this can be a good reason to extend exp dd from 2 to3? since I have removed the Air contact issue and solved by packing with PTP package ? Can this be a suitable reason to get the approval for exp dd extention?

  3. Anonymous says:

    thank you this was so great to read.

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