In the normal course of business, firms typically have an expiration date on their product and, when the product reaches its labeled expiration date, the product is not supposed to be used beyond that date. We all know that the expiration date on a product is usually not always a bright line after which being crossed the product will crash and burn. It is just a date after which the sponsor or the Agency has no data upon which to recommend continued usage of the product based on their own stability programs.
The FDA actually has a program in place for expiration date extension for drugs held in the national stockpile of medications. Often, participating products are evaluated at given pre- and post-expiration date intervals to determine whether a “beyond expiration use” is advisable. The FDA looks at data that it generates, as well as manufacturers’ data, and decides whether to replace product in the stockpile or extend the expiration date beyond the original expiration date on the label. This program is not open for run-of-the-mill product, but only for those products deemed necessary for storage in the national stockpile.
However, faced with the plethora of certain drug shortages, the FDA may evaluate data submitted by sponsors that, in specific circumstances, may be used to support an extension of an expiration dating period beyond the product’s labeled expiration date. The FDA has just released its newest update to that list of acceptable-beyond-expiration-date products, along with the new period of acceptable “beyond use” dates. This is one way the Agency is addressing drug shortages and often the expiration dates are extended by a few months to up to a year.
The FDA says:
Based on stability data provided by the manufacturers and reviewed by FDA, the following extended use dates are supported for specific lot numbers indicated in the searchable table below. Providers and patients that have the lot numbers in stock will be able to use them through the corresponding new use dates to help with supply. As data become available, this list can continue to expand.
FDA is not requiring or recommending that the identified lot numbers in the following table be relabeled with their new use dates. However, if replacement product becomes available during the extension period, then the agency expects the lots in these tables will be replaced and properly disposed of as soon as possible.
The full list of products can be found here.
