> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Unit-Dose Expiration Dating Guidance
- URL: https://www.fdaweb.com/unit-dose-expiration-dating-guidance/
- Published: 2020-07-29T12:00:00.000Z
- Updated: 2026-09-14T16:23:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147305

FDA has published a guidance, *Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products*, to describe the circumstances under which the agency generally does not intend to take action regarding required stability studies for the repackaged products and appropriate expiration dates under those circumstances. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/expiration-dating-unit-dose-repackaged-solid-oral-dosage-form-drug-products?utm%5Fcampaign=SBIA%3A%20Guidance%20Repackaged%20solid%20oral%20dose&utm%5Fmedium=email&utm%5Fsource=Eloqua) 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.

FDA says the guidance does not address repackaging involving other dosage forms or products repackaged by state-licensed pharmacies, federal facilities, and outsourcing facilities.