Many prescription pharmaceuticals retain their full potency for decades beyond their manufacturer-ascribed expiration dates

Tuesday, February 21st, 2023

Eight long-expired medications with 15 different active ingredients were discovered in a retail pharmacy in their original, unopened containers:

All had expired 28 to 40 years prior to analysis. Three tablets or capsules of each medication were analyzed, with each sample tested 3 times for each labeled active ingredient. No analytical standard for homatropine could be found, so that ingredient was not tested.

[…]

Twelve of the 14 drug compounds tested (86%) were present in concentrations at least 90% of the labeled amounts, the generally recognized minimum acceptable potency. Three of these compounds were present at greater than 110% of the labeled content. Two compounds (aspirin and amphetamine) were present in amounts of less than 90% of labeled content. One compound (phenacetin) was present at greater than 90% of labeled amounts from 1 medication tested, but less than 90% in another medication that contained that drug.

[…]

The Shelf-Life Extension Program (SLEP) checks long-term stability of federal drug stockpiles. Eighty-eight percent of 122 different drugs stored under ideal environmental conditions had their expiration dates extended more than 1 year, with an average extension of 66 months and a maximum extension of 278 months. In our data set, 12 of 14 medications retained full potency for at least 336 months, and 8 of these for at least 480 months.

[…]

The most important implication of our study involves the potential cost savings resulting from lengthier product expiration dating. Each dollar spent on SLEP to demonstrate longer than labeled drug stability results in $13 to $94 saved on reacquisition costs. Given that Americans currently spend more than $300 billion annually on prescription medications, extending drug expiration dates could yield enormous health care expenditure savings.

In conclusion, this study provides additional evidence that many prescription pharmaceuticals retain their full potency for decades beyond their manufacturer-ascribed expiration dates. Given the potential cost-savings, we suggest the current practices of drug expiration dating be reconsidered.

Comments

  1. Gavin Longmuir says:

    28 to 40 years ago, those medications were made in the US. Today, the active ingredients in most medications come either directly from China or indirectly from China through India, which much less US insight & control of the manufacturing process.

    Might that affect the conclusion about extending the shelf life?

  2. Felix says:

    They compare these 8 drugs’ contents to the FDA’s current content requirements. Not to the contents of actual drugs at the time these drugs were made – which contents may have varied as much as these 8′s.

    And only 8 types of drugs is an anecdote, not “truth”.

    But they acknowledge all this.

    Question is: How much drugs are tossed out because they’ve aged out, either at the pharmacy or warehouse or home?

  3. Lu An Li says:

    I am not sure but this article the U. S. Army did some years ago and did conclude the shelf life of pharma tends to be much longer than labeled. You might well guess the army has warehouses stockpiled with all sorts of medications.

    Quite a cost saving measure if true. Rather than just throw out whole shelves full of pills and replace by life date on label.

  4. Jim says:

    Very interesting.

  5. Harvey says:

    Are there any simple, easy to perform, steps to help prescription drugs last longer such as refrigeration?

  6. Isegoria says:

    Yes, the usual measures should work. Keep them in a cool, dark, dry place.

Leave a Reply