Issue Date: July 29, 2020
Issued by: Center for Drug Evaluation and Research
Topic(s): Current Good Manufacturing Practice (CGMP), Pharmaceutical Quality
Status: Final
Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products: Guidance for Industry
The last few decades have seen an increasing demand in various health care settings for solid oral dosage form drug products repackaged into unit-dose containers, which hold a quantity of drug for administration as a single dose. The increase in unit-dose repackaging has led to questions regarding stability studies and appropriate expiration dates for these repackaged products. This guidance describes the circumstances under which FDA generally does not intend to take action regarding required stability studies for these repackaged products and appropriate expiration dates under those circumstances.
Download the Guidance Document
