The USFDA recently finalized the guidance for industry entitled “Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products”. This guidance addresses repackaging of prescription and over-the-counter (OTC) solid oral dosage form drugs into unit-dose containers by commercial pharmaceutical repackaging firms. As per the FDA guidance, the increase in unit-dose repackaging over last few decades has led to questions regarding stability studies and appropriate expiration dates for these repackaged products.
USFDA proposed to tighten the previously proposed expiration dates for oral solid drugs from one year to just six months after they are repackaged into unit doses, except under certain circumstances. This is aligned with USP (United States Pharmacopeia) standards on expiration dating.
USFDA does not intend to take action regarding certain stability study requirements for repackaged drug products in the following cases: