Which item must be included on compounded drug products made in advance?

• A. Expiration date or BUD
• B. The repackager's license number
• C. The patient's name
• D. The color of the container

Answer: (A)

When drugs are prepared ahead of time, the label must communicate how long the product remains safe and effective. The expiration date or beyond-use date tells you the exact window in which the compounded preparation should be used, given how long it’s been stored and under which conditions. This date is essential for safety and potency, guiding storage, handling, and when to discard the product to avoid using an item that may have degraded or become unsafe.

Other items aren’t required on every label for compounded products made in advance. A repackager’s license number isn’t a universal labeling requirement for such goods, the patient’s name is only necessary when the product is specifically prepared for that patient, and the color of the container has no direct impact on safety or regulatory labeling requirements.