Business · 30/07/2020

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

The Food and Drug Administration (FDA) has released a final guidance for the pharmaceutical industry regarding the expiration dating of unit-dose repackaged solid oral dosage form drug products. The guidance clarifies the circumstances under which the FDA will not require stability studies or set expiration dates for these products.