Optimization of repackaging practices for solid oral forms

Introduction
Drug repackaging consists of transferring a medicinal product from its original primary packaging to a unit-dose format. In 2024, a total of 78,785 units were repackaged in our facility using heat sealing at 117°C. Post-repackaging beyond-use dates (BUDs) were set at 6 months for intact products and 3 months for those with a desiccant or subject to splitting. During an inventory, altered sodium valproate tablets were discovered, raising concerns about the impact of repackaging on drug quality.

Objective
This study aims to optimize the repackaging practices of solid oral forms by defining clear criteria in line with current recommendations. This includes revising BUDs and developing a feasibility assessment file applicable to relevant medicinal products.
Method:
The study followed four steps: analysis of existing guidelines and literature review, regional audit of current practices, development of a feasibility file template, and application to repackaged medicines.

Results
The analysis of recommendations and literature revealed inconsistencies, particularly regarding BUD determination. The regional audit highlighted heterogeneous practices: out of 12 centers surveyed, 7 responded. Three centers apply a default BUD of 6 months, reduced when desiccants or splitting are involved; one follows the 2023 Good Preparation Practices (GPP); one applies a 2-month BUD (in line with the Pharmacy Automation Users Group – CUAP recommendations); and one does not perform repackaging. Upon review, the GPP methodology appeared unsuitable for repackaging solid oral forms. A hybrid approach, combining CUAP guidelines and bibliographic data, was therefore adopted. This led to a reduction in BUDs to 2 months for intact products and 1 month in cases involving desiccants or splitting, unless a stability study is available, with a maximum limit of 6 months (GPP). A feasibility file template was developed in accordance with the 2023 GPP. The integration of recommendations from the National Institute for Occupational Safety and Health (NIOSH) altered practices: drugs classified as hazardous will now be split under a fume hood to limit exposure. In total, 35 feasibility files were completed after reviewing all repackaged medicines.

Conclusion
Optimizing the repackaging practices for solid oral forms has enabled procedure harmonization, improved risk control, and revised BUDs. The development of validated feasibility files ensures a structured approach aligned with regulatory requirements. These results underscore the importance of ongoing reassessment of repackaging practices to ensure the quality of repackaged medicines.

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