Once a multi-dose vial (MDV) has been opened, what is the maximum beyond-use date unless otherwise specified?

The maximum beyond-use date for a multi-dose vial (MDV) once it has been opened is 28 days, in accordance with the standards outlined in USP 797. This guideline is in place to ensure patient safety and the integrity of compounded sterile products.

Multi-dose vials are designed for multiple uses and have preservatives that allow them to be used over a period of time. However, once the vial is opened, it becomes more susceptible to contamination and degradation, which can occur due to exposure to the environment or through repeated punctures. The 28-day designation helps to mitigate these risks by providing a clear timeframe within which the contents of the vial should be used to maintain safety and efficacy.

It's important for practitioners to adhere to this timeline and document the opening date on the vial, as it helps in managing product inventory and assures compliance with safety standards intended to protect patients.