25-27 April 2023
The U.S. Food and Drug Administration (FDA) 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 in line with USP (United States Pharmacopeia) standards on expiration dating.
The FDA states that this action was taken in response to "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".
The draft guideline Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products was announced on August 8, 2017, and replaces the draft guidance for industry Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy Guide (2005). In addition, once final, it will supersede Compliance Policy Guide 480.200 Expiration Dating of Unit-Dose Repackaged Drugs (1995). Comments regarding the draft document should be submitted within 60 days of publication.
In the previous draft guidance on expiration dating issued in May 2005, the FDA had proposed to set the expiration date for nonsterile, unit-dose repackaged drugs to one year, which was also aligned with USP standards at the time for beyond use dating for unit-dose repackaging by dispensers.
According to the FDA, the present draft guidance "addresses repackaging of prescription and over-the-counter solid oral dosage form drugs into unit-dose containers by commercial pharmaceutical repackaging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 under section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and to comply with current good manufacturing practice (cGMP) regulations in 21 CFR parts 210 and 211".
The 7-paged guidance does not cover
FDA’s cGMP regulations for finished products require that "each drug product bear an expiration date determined by appropriate stability testing and that the date must be related to any storage conditions stated on the labeling, as determined by stability studies". Samples used for stability testing must be in the same container-closure system as the marketed drug to ensure the drug product’s safety and efficacy over its intended shelf life.
Additionally, United States Pharmacopeia (USP) General Chapter <7> Labeling states that “the label of an official drug product … shall bear an expiration date.” For unit-dose repackaged products, USP General Chapter <1178> Good Repackaging Practices recommends that the expiration date “not exceed
FDA will not enforce certain stability study requirements for repackaged drug products in the following cases:
The FDA also proposes to permit the expiration date to exceed the ones described above, provided the above-listed conditions are met and if repackagers have supportive data from appropriate studies (including a risk-based assessment), using an adequate number of samples. These samples need to demonstrate that the container closure system used for repackaging is at least as protective for the drug product as the original packaging. However, "the expiration date of the repackaged product does not exceed the original manufacturer’s expiration date".