What does Beyond-use dating (BUD) guide?

• A. Requirements for labeling and patient counseling.
• B. Recommendations for assigning safe BUDs based on formulation, sterility, and stability testing.
• C. Criteria for determining when a drug must be recalled.
• D. Procedures for compounding non-sterile preparations only.

Answer: (B)

Beyond-use dating sets the safe time window for using a compounded preparation after it leaves the pharmacy. This date isn’t the same as an expiration; it reflects how long the product is expected to remain potent and free from contamination under specified storage conditions.

The guidance is based on what the preparation is and how it’s made: the formulation, whether it’s sterile or non-sterile, and the stability data supported by testing. For sterile products, sterility considerations and validated storage and handling influence the BUD. For non-sterile products, microbial risk and stability data drive the recommended dating. In all cases, the BUD is pulled from testing that demonstrates the product stays within specification over time, including how packaging and storage conditions affect integrity.

Keep in mind that this isn’t about labeling and patient counseling in isolation, nor about recalling drugs, and it isn’t limited to non-sterile preparations. BUDs apply to both sterile and non-sterile compounded items and hinge on empirical stability and sterility information.