Company Warned for Arbitrarily Assigning Pill Expiration Dates

Company Warned for Arbitrarily Assigning Pill Expiration Dates

October 11th, 2011 // 1:25 pm @

File this under Inventory Management 101. Want to know a novel way to determine an expiration date for your pills? Align it with sales performance. No, a drugmaker did not engage in such unusual thinking, but a dietary supplement maker has done so. And while this site generally does not venture often into the supplement world, we thought pointing out the – ingenuity? foolishness? – would be worth noting.

Here is the short version: Last May, the FDA inspected facilities run by Herbal Nitro in Yucaipa, California, which actually uses contract manufacturers to produce its various supplements. The company markets pills for various purposes, but the two cited in a September 22 warning letter from the FDA mentions capsules that are for weight loss and the male libido.

The agency found various problems, such as failing to conduct at least one appropriate test or exam to verify the identity of a component that is a dietary ingredient, prior to its use. And Herbal Nitro also failed to establish specifications for identity, purity, strength, and composition for each component used to make its supplements.

These are basic procedures and the failures suggest serious problems. But toward the bottom of the letter, a more intriguing passage is found. The FDA says its inspectors were told that expiration dates “are arbitrarily assigned based on product sales.” In other words, if there is an inventory build up, just change the expiration date until the product moves. Why waste pills, right?

As the agency notes, “any expiration date you place on a product label should be supported by data that demonstrates the product’s shelf life.” This should have been obvious. Then again, no one in the pharmaceutical industry, which is squeezing costs left and right, should get the wrong message from this episode, yes?

Source: Pharmalot


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