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

Summary:

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:

  • if an expiration date that does not exceed 6 months from the date of repackaging is assigned, or

  • if 25 percent of the time between the date of repackaging and the expiration date on the container of the original manufacturer’s product is used as expiration date, whichever time period is shorter and further the following conditions are met:

    • The unit-dose container complies with Class A or Class B standards as described in USP General Chapter <671> ContainersPerformance Testing.
    • The unit-dose repackaging container-closure system provides light protection equal to or greater than that of the drug product’s original container-closure system.
    • The drug product’s original container has not been opened previously and the entire contents are repackaged in one operation.
    • Repackaging and storage occur in an environment that is consistent with the conditions described in the original drug product’s labeling.
    • The drug product’s labeling does not caution against repackaging.

FDA also proposed to permit the expiration date to exceed the ones described above, provided the above-listed conditions are met and if supportive data from appropriate studies, using an adequate number of samples, demonstrate that the container-closure system used for repackaging is at least as protective of the drug product as is the original packaging. However, the expiration date of the repackaged product should not exceed the original manufacturer’s expiration date.