What is the beyond-use dating (BUD) for nonaqueous formulations prepared in a community pharmacy?

• A. 2 weeks
• B. 3 months
• C. 6 months
• D. 12 months

Answer: (C)

Beyond-use dating for compounded products is the date after which a preparation should not be used, based on how it’s made and what ingredients it contains. For nonaqueous formulations—oil-based or solvent-based mixtures—the absence of water reduces microbial risk, but chemical stability still limits how long the product stays safe and effective. Because of that, the standard BUD is six months, unless an ingredient’s expiration date is sooner. In practice, you assess the earliest expiration among all ingredients and that becomes the BUD if it’s earlier than six months. A longer date like twelve months isn’t allowed for these formulations, while a much shorter date like two weeks would be unnecessarily conservative given typical stability.