In-use Storage Time of Reconstituted Medicines

The Council of Europe’s CD-P-PH/PC Committee (co-ordinated by the EDQM) has published a position paper on in-use storage times for reconstituted parenteral medicines. The new paper highlights a gap between the stability data submitted for marketing authorisations and clinical use, calling for regulatory requirements that better reflect hospital practices.

Background

Based on a 2024 survey of hospital pharmacists in Council of Europe member states, it notes that hospital pharmacies sometimes set longer in-use times than those stated in the SmPC (Summary of Product Characteristics) due to practical constraints. The paper cautions that extending storage beyond SmPC limits

• May compromise safety and efficacy,
• Occurs outside authorised conditions,
• Places responsibility on the healthcare professional performing the reconstitution.

It also identifies a mismatch between stability data used for marketing authorisation and real clinical use, calling for regulatory requirements that better reflect hospital practice and urging industry to generate additional in-use stability data and seek SmPC/package leaflet updates where justified.

For more information please see the Council of Europe position paper published in the EDQM Newsroom.