Beyond-use date (BUD) by type of formulation*
- Non-aqueous formulations: the BUD is not later than the time remaining until the earliest expiry date of any API or six months, whichever is earlier.
- Water-containing oral formulations: the BUD is not later than 14 days with storage at controlled cold temperatures.
- Water-containing topical/dermal, mucosal liquid, and semi-solid formulations (such as preparations for topical application, like creams, gels, etc.): the BUD is not later than 30 days.
*These maximum BUDs are recommended for non-sterile compounded drug preparations in the absence of stability information that is applicable to a specific drug or preparation. The BUD shall not be later than the expiration date on the container or any component.
For water-containing topical/dermal, mucosal liquid, and semi-solid formulations, the assigned BUD must generally not be later than 30 days. Assigning alternative BUD dates requires a critical appraisal of literature and stability documentation that is applicable to the specific drug or preparation in question. “Water-containing” may refer both to preparations where water has been added as an ingredient, or where water is already inherently a component of the formulation (e.g., creams, gels, etc.).