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# Draft Unit-Dose Expiration Dating Guidance
- URL: https://www.fdaweb.com/draft-unit-dose-expiration-dating-guidance/
- Published: 2017-08-08T12:00:00.000Z
- Updated: 2026-09-14T22:39:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139331

FDA has published a draft guidance, *Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products*, describing the conditions under which the agency does not intend to take action regarding required stability studies and expiration dates for repackaged unit-dose solid oral dosage form drug products. The [document](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070278.pdf?ref=fdaweb.com) addresses repackaging of prescription and over-the-counter solid oral dosage form drugs into unit-dose containers by commercial pharmaceutical repackaging firms that are required to register with FDA and to comply with current good manufacturing practice regulations.

According to the guidance, FDA does not intend to take action if the covered products are assigned an expiration date that does not exceed **(1)** six months from the date of repackaging, or **(2)** 25% of the time between the date of repackaging and the expiration date on the container of the original manufacturer’s product, whichever time period is shorter, and if five specified conditions are met. And FDA will not act against products with longer expiration dates if additional specified conditions are met.