Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products | FDA

Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products | FDA





FDA Announces Availability of Final Guidance – Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products

Today, FDA is announcing the availability of a final guidance for industry titled, "Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products." This guidance describes the conditions under which FDA generally does not intend to take action regarding required stability studies for repackaged products and the expiration date to assign under those conditions. This guidance finalizes the revised draft guidance issued in August 2017.

Unit-dose containers hold a quantity of drug for administration as a single dose. In the last few decades, health care settings, such as hospitals and long-term care facilities, have increased their demand for solid oral dosage form drug products repackaged into unit-dose containers. This increase in unit-dose repackaging has led to questions regarding stability studies and appropriate expiration dates for these repackaged products. This guidance addresses repackaging of prescription and over-the-counter solid oral dosage form drugs into unit-dose containers by commercial pharmaceutical repackaging firms that are required to register with FDA under section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and to comply with current good manufacturing practice (CGMP) regulations in 21 CFR parts 210 and 211.