Determining Drug Product Shelf Life

Occasionally I get asked why a compounded product does not have an expiration date as long as that of a manufactured product. Expiration dates are required by the FDA for commercially manufactured products and are determined after years and years of extensive study of the product’s stability. Most expiration dates are expressed in years for commercial products.

Since compounded products do not undergo years of extensive study to determine the product’s stability, a much more conservative methodology, dictated by USP 797 guidelines, must be used for sterile compounded products. Under USP 797, sterile compounded products are not assigned an expiration date, instead, they are assigned a “beyond use date” (BUD). BUDs are generally days or month long and are determined after careful interpretation of appropriate information sources for the same or similar formulations. The BUDs, for products produced by those pharmacies that do not test drug strength or stability, are strictly limited to USP 797 guidelines resulting in BUDs of as little as 24 hours to a maximum of 45 days. When pharmacies send their products to a lab for strength and stability testing, like JCB does, BUDs as long as 6 months can be assigned. So, while a compounded product will have a BUD based on sound clinical information and testing, it will not have a BUD equal to that of a manufactured product.

Compounded products fill a vital need in today’s healthcare arena whether by customizing a medication for a physician or by solving a critical drug shortage. Ensure confidence with your staff and patients by performing the necessary due diligence to make sure that your sterile compounding pharmacy uses sound procedures to determine Beyond Use Dates.

Posted in