Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products; Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products." The guidance describes the circumstances under which FDA generally does not intend to take action regarding required stability studies for unit-dose repackaged solid oral dosage form drug products and appropriate expiration dates under those circumstances. This guidance finalizes the revised draft guidance for industry issued in August 2017.