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

A new 4-page guidance from FDA comes on the heels of an increase in repackaging drugs for administration as a single dose.

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The practice of repackaging oral solid dose drugs into unit-dose containers has increased in the last few decades.

 Per the FDA’s release, “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.”

Drugs must meet five criteria, including that the drug’s original labeling does not caution against repackaging.

View the 4-page guidance here:  Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products

Submit comment here: Federal Register

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