Medication - Sterile Compounding - Extending Beyond Use Dates (BUD) with Closed System Transfer Devices (CSTD)
Can a Closed System Transfer Device be utilized to extend the beyond use date of a single dose container ?
Any examples are for illustrative purposes only.
The Joint Commission would evaluate compliance with the use of a closed system transfer device (CSTD) based on the FDA approved indications of a device. Based on feedback received directly from the FDA, the extension of a beyond use date beyond 6 hours for a single dose vial has not been approved as an indication.
The Joint Commission is aware of published articles which supports the use of these devices to extend beyond use dating longer than the 6 hours allowed for a single dose vial. However, this has not been approved by the FDA and is not supported as a standard of practice.
The Joint Commission would evaluate compliance with the use of a closed system transfer device (CSTD) based on the FDA approved indications of a device. Based on feedback received directly from the FDA, the extension of a beyond use date beyond 6 hours for a single dose vial has not been approved as an indication.
The Joint Commission is aware of published articles which supports the use of these devices to extend beyond use dating longer than the 6 hours allowed for a single dose vial. However, this has not been approved by the FDA and is not supported as a standard of practice.
Manual:
Home Care
Chapter:
Medication Compounding MC
First published date: January 23, 2018
This Standards FAQ was first published on this date.
This page was last updated on November 05, 2024
with update notes of: Editorial changes only
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