FDA issues new unit-dose repackaging guidance
Unit-dose repackaged oral solid medications will generally not be subject to US Food and Drug Administration (FDA) action regarding nonconformance with expiration date provisions, so long as certain requirements are met.The agency issued the guidance in the context of the increasingly common practice of repackaging solid oral medications into unit-dose containers for hospitals and long-term care facilities. “The increase in unit dose repackaging has led to questions regarding stability studies and appropriate expiration dates for these repackaged products,” noted FDA in the new guidance.
For unit-dose repackaged products that are assigned and labeled with an expiration date not exceeding a period of time that is the shorter of 6 months from the date of repackaging or 25% of the time between the repackaging date and the original expiration date, FDA does not intend to take action regarding nonconformance with expiration dating determined by stability studies as provided in 21 CFR parts 211.137 and 211.166, according to the guidance.
However, the agency includes additional requirements repackagers must meet to fall under the new guidance. Unit-dose containers must also comply with Class A or B standards as set forth in General Chapter 671 of the US Pharmacopeia (USP). The guidance includes additional specifications for when class B containers may be used. Also, light-sensitive drug products must be repackaged in a container providing at least as much light protection as the original container-closure system.
Further, repackaging must occur in one operation from an original container that had not previously been opened. Repackaging and storage should happen in “an environment that is consistent with the conditions described in the original drug product’s labeling,” according to the guidance, and the original labeling must not caution against repackaging.
Repackagers should have data from “appropriate studies, using an adequate number of samples” showing that the repackaging container-closure system protects the drug at least as well as did the original packaging.
The agency clarified that the guidance does not address repackaging for liquid dosage forms, or for products that are repackaged by state licensed pharmacies, federal facilities, or outsourcing facilities.
FDA