Beyond use dates (BUDs) are different from expiration dates. Manufactured drugs have expiration dates, which are determined through extensive studies of the drugs’ stability, whereas compounded medications use BUDs.
A BUD is the time after which a compounded product, either nonsterile or sterile, may not be stored or transported (1). BUDs can be determined based on stability information about the specific drug, but also can rely on the United States Pharmacopeia (USP) standards for default dating when stability studies aren’t available. In the absence of stability testing, the maximum BUDs for non-sterile compounds can be found in the table below.
A compounding pharmacy may send a compounded product that has a BUD that differs from the table. BUDs can be extended when appropriate stability information has been published in peer-reviewed journals. There are many resources that publish information about BUDs, including Trissel’s Stability of Compounded Formulations, United States Pharmacopeia, Journal of Pharmaceutical Sciences, and the International Journal of Pharmaceutical Compounding. The compounding pharmacy should reference the citation that allows them to extend the BUD, if you have questions regarding the product.
|Category||Beyond Use Date||Storage|
|Nonaqueous formulations (containing no water)||No longer than 6 months; or the earliest expiration date of any ingredient used||Controlled room temperature|
|Water-containing oral formulations||No longer than 14 days; or the earliest expiration date of any ingredient used||Controlled cold temperature|
|Water-containing topical/dermal and mucosal liquid and semisolid formulations||No longer than 30 days; or the earliest expiration date of any ingredient used||Controlled room temperature|
- USP Compounding Standards and Beyond-Use Dates (BUDs). United States Pharmacopeia, 3 June 2019. https://www.usp.org/sites/default/files/usp/document/our-work/compounding/usp-bud-factsheet.pdf.
This month’s column is from Alex Gochenauer, PharmD, FSVHP.