USA – FDA issues new unit-dose repackaging guidance

Unit-dose repackaged oral solid medications will generally not be subject to US Food and Drug Administration (FDA) action regarding nonconformance with expiration date provisions, so long as certain requirements are met.

The agency issued the guidance in the context of the increasingly common practice of repackaging solid oral medications into unit-dose containers for hospitals and long-term care facilities. “The increase in unit dose repackaging has led to questions regarding stability studies and appropriate expiration dates for these repackaged products,” noted FDA in the new guidance.

For unit-dose repackaged products that are assigned and labeled with an expiration date not exceeding a period of time that is the shorter of 6 months from the date of repackaging or 25% of the time between the repackaging date and the original expiration date, FDA does not intend to take action regarding nonconformance with expiration dating determined by stability studies as provided in 21 CFR parts 211.137 and 211.166, according to the guidance…