What is the maximum allowable expiration date on a repackaged unit-dose medication?

The maximum allowable expiration date on a repackaged unit-dose medication is determined by regulatory guidelines, which state that this date should be established as whichever occurs first between one year from the date of repackaging and the manufacturer’s expiration date. This criterion helps ensure that the medication remains safe and effective for patients while adhering to established safety protocols.

Setting the expiration date to one year is a standard practice that allows for a reasonable duration of use, ensuring the medication does not remain in circulation beyond its efficacy. However, if the manufacturer's expiration date is earlier than one year, it takes precedence to prevent patients from receiving medications that may be ineffective or unsafe due to age.

This approach emphasizes the importance of both safety and adherence to the original manufacturer’s guidance, ensuring that repackaged medications are handled properly within clinical settings. Therefore, when repackaging medications for unit-dose distribution, the correct practice is to use the sooner of these two dates—maintaining a balance between compliance and patient safety.